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Data Published in The Lancet Compare Dabigatran Etexilate to Dose-Adjusted Warfarin Across RE-LY® Trial Centers

Sun, 29 August 2010 15:00:00 GMT

- Sub-analysis shows no significant interaction between trial centers’ time in therapeutic range and stroke with either dose of dabigatran etexilate compared to warfarin¹ -

Ridgefield, CT, August 29, 2010 — Boehringer Ingelheim today announced results from a pre-specified, retrospective, un-blinded sub-analysis of the RE-LY® trial – the largest atrial fibrillation outcomes trial ever conducted² – were published in The Lancet. The sub-analysis evaluated the primary outcomes of RE-LY® in relation to each center’s average time in therapeutic range (cTTR) (INR 2.0-3.0) for patients taking warfarin.¹

Study centers were placed into one of four groups based on cTTR (<57.1%, 57.1%-65.5%, 65.5%-72.6% and >72.6%).¹ Primary outcomes were assessed across the three treatment arms (dabigatran etexilate 110mg BID, dabigatran etexilate 150mg BID, warfarin)¹ and demonstrated:

There was no significant interaction between cTTR and stroke and systemic embolism for either dabigatran etexilate 110mg BID or dabigatran etexilate 150mg BID compared to warfarin (interaction p=0.89 and 0.20)¹

There was no significant interaction between cTTR and major bleeding with dabigatran etexilate 110mg BID (interaction p=0.50); however, there was a significant interaction when comparing dabigatran etexilate 150mg BID to warfarin (interaction p=0.03), with lower rates at centers where INR control was low, and similar rates at centers where control was higher¹

There was no significant interaction between cTTR and intracranial bleeding for either dabigatran etexilate 110mg BID or dabigatran etexilate 150mg BID compared to warfarin (interaction p=0.71 and 0.89)¹

“Well-controlled warfarin is very effective for the prevention of stroke in patients with atrial fibrillation; however, we know in clinical practice there can be large variations in the level of control,” said Dr. Michael Ezekowitz, professor & vice president, clinical research, Lankenau Institute. “The results of this sub-analysis suggest the level of control achieved across RE-LY trial centers did not influence the effects of dabigatran etexilate compared to warfarin for stroke prevention.”

About the sub-analysis
The individual time in therapeutic range (iTTR) during the trial was calculated using the Rosendaal method for 5,791 patients randomized to warfarin, excluding INRs from the first week and after discontinuation of study drug.¹ For patients who temporarily discontinued warfarin, the time interval between temporary discontinuation and restart of medication was also not counted.¹

Each center’s time in therapeutic range was calculated based on the average iTTR in the group of patients randomized to warfarin.¹ Among the 951 centers, cTTR could not be appropriately estimated at 45 centers because too few patients with serial INR values were available.¹ Accordingly, 18,024 patients from 906 sites were included in the analysis.¹

About RE-LY®: The largest AFib outcomes trial to date²
RE-LY® (Randomized Evaluation of Long-Term Anticoagulation Therapy, Warfarin, Compared with Dabigatran) was a global, Phase III, randomized trial² of 18,113³ patients enrolled in 951 centers in 44 countries,³ investigating whether dabigatran etexilate (two blinded doses) was as effective as well-controlled warfarin – INR 2.0 - 3.0 – (open label) for stroke prevention.³ Patients with non-valvular atrial fibrillation and at least one other risk factor for stroke (i.e., previous ischemic stroke, transient ischemic attack, or systemic embolism, left ventricular dysfunction, age > 75 years, age > 65 years with either diabetes mellitus, history of coronary artery disease, or hypertension) were enrolled in the study for two years with a minimum follow-up period of one year.³

The primary endpoint of the trial was incidence of stroke (including hemorrhagic) and systemic embolism.³ Secondary outcome measures included a composite of incidence of stroke (including hemorrhagic), systemic embolism and all death, as well as a composite of incidence of stroke (including hemorrhagic), systemic embolism, pulmonary embolism, acute myocardial infarction, and vascular death (including death from bleeding).³ Additional safety endpoints included bleeding events (major and minor), intracerebral hemorrhage, other intracranial hemorrhage, elevations in liver transaminases, bilirubin and hepatic dysfunction, and other adverse events. ³

The primary analysis was designed to test whether either dose of dabigatran etexilate was non-inferior to warfarin.³ After non-inferiority of both doses of dabigatran etexilate was established, statistical analysis allowed testing of superiority.³

About atrial fibrillation and stroke
Atrial fibrillation is the most common sustained heart rhythm abnormality⁴ and is associated with up to 15 percent of all strokes in the U.S.⁵ Atrial fibrillation is associated with nearly a five-fold increased risk of stroke,⁵ and atrial fibrillation-related strokes can be about twice as likely to be fatal⁶ or severely disabling⁷ as non-atrial fibrillation-related strokes. An estimated 2.3 million Americans currently have atrial fibrillation⁴ and the prevalence is expected to increase 2.5 fold to 5.6 million by 2050,⁴ reflecting the growing population of elderly individuals. The annual cost of stroke among Medicare atrial fibrillation patients is estimated to be $8 billion.⁸

About dabigatran etexilate
Dabigatran etexilate is not approved by the FDA. Dabigatran etexilate is an investigational oral direct thrombin inhibitor9 being studied in the prevention and treatment of acute and chronic thromboembolic diseases. ^{3,10,11,12,13,14,15}

About Boehringer Ingelheim Pharmaceuticals, Inc.
Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, CT, is the largest U.S. subsidiary of Boehringer Ingelheim Corporation (Ridgefield, CT) and a member of the Boehringer Ingelheim group of companies.

In 2009, Boehringer Ingelheim posted net sales of US $17.7 billion (12.7 billion euro) while spending 21% of net sales in its largest business segment, Prescription Medicines, on research and development.

For more information, please visit http://us.boehringer-ingelheim.com and follow us on Twitter at http://twitter.com/boehringerus.

References

Wallentin, L, et al."Efficacy and Safety of Dabigatran Compared to Warfarin at Different Levels of INR Control for Stroke Prevention in Atrial Fibrillation" Lancet. 2010
2 Ezekowitz MD, et al. “Rationale and Design of RE-LY: Randomized Evaluation of Long-Term Anticoagulation Therapy, Warfarin, Compared with Dabigatran.” American Heart Journal. 2009; 157:805-810.
Connolly S.J., et al. "Dabigatran versus Warfarin in Patients with Atrial Fibrillation." New England Journal of Medicine. 2009; 361.
Go, Alan S., and Elaine M. Hylek, et al. Prevalence of Diagnosed Atrial Fibrillation in Adults: National Implications for Rhythm Management and Stroke Prevention: the ATRIA Study. JAMA . 285(2001): 2370-2375
Wolf P.A., et al. "Atrial Fibrillation as an Independent Risk Factor for Stroke: The Framingham Study." Stroke. 1991; 22:983-988.
Lin H.J., et al. “Stroke Prevention in Atrial Fibrillation: The Framingham Study.” Stroke. 1996; 27:1760-1764.
Dulli D, et al. “Atrial Fibrillation is Associated with Severe Ischemic Stroke.” Neuroepidemiology. 2003; 22: 118-123.
Caro, J. “An Economical Model of Stroke in Atrial Fibrillation: The Cost of Suboptimal Oral Anticoagulation.” The American Journal of Managed Care. 2004; 10:S451-S461.
Di Nisio, et al. “Direct Thrombin Inhibitors.” New England Journal of Medicine. 2005; 353: 1028-40.
Eriksson BI, et al. “Dabigatran Etexilate Versus Enoxaparin for Prevention of Venous Thromboembolism After Total Hip Replacement: a Randomized, Double-Blind, Non-Inferiority Trial.” The Lancet. 2007; 370:949-956.
The RE-MOBILIZE Writing Committee. “Oral Thrombin Inhibitor Dabigatran Etexilate vs North American Enoxaparin Regimen for Prevention of Venous Thromboembolism After Knee Arthroplasty Surgery.” The Journal of Arthroplasty. 2009; 24:1-9.
ClinicalTrials.gov. “A Phase III Randomised, Parallel Group, Double-Blind, Active Controlled Study to Investigate the Efficacy and Safety of Orally Administered 220 mg Dabigatran Etexilate Capsules (110 mg Administered on the Day of Surgery Followed by 220 mg Once Daily) Compared to Subcutaneous 40 mg Enoxaparin Once Daily for 28-35 Days, in Prevention of Venous Thromboembolism in Patients With Primary Elective Total Hip Arthroplasty Surgery. (RE-NOVATE II).” Available at: http://www.clinicaltrials.gov/ct2/show/NCT00657150?term=dabogatran&rank=7. Accessed on: January 28, 2009.
ClinicalTrials.gov. “A Randomised, Multicenter, Double-Blind, Active Controlled Study to Investigate the Efficacy and Safety of Dabigatran Etexilate, 150 mg b.i.d Administered Orally (Capsules) for 18 Months, Compared to Warfarin Tablets p.r.n. (Target INR) for the Secondary Prevention of Venous Thromboembolism.” Available at: http://www.clinicaltrials.gov/ct2/show/NCT00329238?term=dabigatran&rank=12. Accessed on: January 28, 2009.
ClinicalTrials.gov. “A Phase III, Randomised, Double Blind, Parallel-Group Study of the Efficacy and Safety of Oral Dabigatran Etexilate (150 mg Bid) Compared to Warfarin (INR 2.0-3.0) for 6 Month Treatment of Acute Symptomatic Venous Thromboembolism, Following Initial Treatment (5-10 Days) With a Parenteral Anticoagulant Approved for This Indication.” Available at: http://www.clinicaltrials.gov/ct2/show/NCT00680186?term=dabigatran&rank=5. Accessed on: January 28, 2009.
ClinicalTrials.gov. “RELY-ABLE Long Term Multi-center Extension of Dabigatran Treatment in Patients with Atrial Fibrillation Who Completed RE-LY Trial to Assess the Effect of a Knowledge Translation Intervention on Patient Outcomes.” Available at: http://www.clinicaltrials.gov.ct2.show/NCT00808067?term=dabigatran&rank=10. Accessed on: July 23, 2009.

Study shows once-daily, extended-release formulation of nevirapine was not inferior to twice-daily VIRAMUNE in treatment-naïve HIV-1 infected patients

Thu, 22 July 2010 15:00:00 GMT

Ridgefield, CT, July 22, 2010 – New data were presented today at the 18th International AIDS Conference from the VERxVE study that show an investigational, once-daily extended-release (400 mg QD) formulation of nevirapine was non-inferior to twice-daily immediate release Viramune® (nevirapine) tablets (200 mg BID), both in combination with Truvada® (tenofovir and emtricitabine) tablets in treatment-naïve HIV-1 infected patients through 48 weeks.

“We are pleased to see that the VERxVE study met its primary endpoint, and provided data on the efficacy and safety of an investigational, extended-release formulation of nevirapine,” said Peter Piliero, M.D., executive director, Medical Affairs, Boehringer Ingelheim Pharmaceuticals, Inc.

The investigational, extended-release formulation of nevirapine had a similar safety profile to immediate release VIRAMUNE in the trial.

VERxVE was a randomized, double-blind, double-dummy, parallel group, active controlled trial that evaluated the antiviral efficacy of the extended-release formulation of nevirapine in comparison to immediate release VIRAMUNE, both in combination with Truvada®, in treatment-naive HIV-1 infected patients. A total of 1,068 patients enrolled in VERxVE and 1,011 patients were randomized and received either the extended-release (400 mg QD) formulation of nevirapine or immediate release VIRAMUNE (200 mg BID) after a required 14-day lead-in period with immediate release VIRAMUNE for all patients. All patients also received a NRTI backbone of Truvada®.

The study’s primary endpoint was confirmed virologic response through 48 weeks of treatment, with response defined as a viral load of <50 copies/mL measured on two consecutive occasions at least two weeks apart prior to or at week 48 and without subsequent rebound or change of therapy prior to or at week 48. VERxVE follow-up is currently planned to continue for a total of 144 weeks.

Boehringer Ingelheim Pharmaceuticals, Inc. is working with regulatory authorities to make the extended-release formulation of nevirapine available.

VERxVE Results
Of the patients who received the extended-release formulation of nevirapine (400 mg QD) in the study, 81 percent (409/505) achieved the study’s primary endpoint of viral load of < 50 copies/mL on two occasions by week 48 and without subsequent rebound or change of antiretroviral therapy prior to or at week 48, vs. 76 percent (384/506) of patients taking immediate release VIRAMUNE (200 mg BID) (95 percent CI -0.11 to +9.96).

In patients with a HIV-RNA >100,000 copies/mL at baseline, the response rate was 73 percent for the extended-release formulation of nevirapine vs. 71 percent for immediate release Viramune® (nevirapine) tablets. In patients with baseline HIV-RNA ≤ 100,000 copies/mL, the response rate was 79 percent for patients taking immediate release VIRAMUNE compared to 86 percent for patients taking the extended-release formulation of nevirapine.

In the VERxVE trial, a double-blind, double-dummy study, adverse events seen with the extended-release formulation of nevirapine were similar to those seen with the FDA-approved immediate release VIRAMUNE. The most common adverse events for the extended-release formulation of nevirapine were nasopharyngitis (inflammation of the nasal passages), diarrhea, upper respiratory tract infection, rash and headache. No new or unexpected safety issues were identified for immediate release VIRAMUNE. The number of discontinuations due to adverse events in the extended-release formulation of the nevirapine study arm was 32 (6.3 percent) vs. 45 (8.9 percent) in the immediate release VIRAMUNE study arm. The rate of symptomatic hepatic events was 1.6 percent in patients taking the extended-release formulation of nevirapine compared to 2.8 percent in those taking immediate release VIRAMUNE. The rate of rash events in the study was 8.3 percent vs. 8.7 percent respectively for the extended-release formulation of nevirapine and immediate release VIRAMUNE. The safety data presented in this paragraph showed no statistically significant difference between arms.

Three cases of Stevens-Johnson syndrome occurred with the use of immediate release VIRAMUNE during the two week lead-in dose while another two cases occurred after randomization, also in the immediate release arm. There was no occurrence of Stevens-Johnson syndrome in patients randomized to the extended-release formulation of nevirapine. The VERxVE data demonstrates a similar safety profile between the two arms, and therefore, the absence of Stevens-Johnson syndrome with the extended-release formulation of nevirapine in this study does not mean that it cannot occur.

Data captured during the 14-day lead-in period (when all patients received immediate release VIRAMUNE (200 mg QD) before being randomized to the extended-release formulation of nevirapine or immediate release VIRAMUNE arms of the study) are not included in the VERxVE analysis. The immediate release formulation of VIRAMUNE (200 mg BID) is not otherwise approved for once-daily dosing, as the safety and efficacy of once-daily dosing has not been established.

Important Safety Information for immediate release Viramune® (nevirapine) tablets
VIRAMUNE is indicated for use in combination with other antiretroviral agents for the treatment of HIV infection.

VIRAMUNE does not cure HIV or AIDS, and has not been shown to reduce the risk of passing HIV to others through sexual contact or blood contamination.

VIRAMUNE can cause severe liver disease and skin reactions that can cause death. These reactions occur most often during the first 18 weeks of treatment, but can occur later. Ask your healthcare provider about how to recognize symptoms of skin and liver problems.

Stop taking Viramune® (nevirapine) tablets if you have any of these reactions. Do not restart VIRAMUNE if you experience any of these reactions. Call your healthcare provider immediately if you have any of these reactions.

VIRAMUNE is only for people diagnosed with HIV. If you have not been diagnosed as HIV positive, then do not take VIRAMUNE.

Any patient can experience liver problems with VIRAMUNE, but women and patients who have higher CD4 counts when they begin VIRAMUNE treatment have a greater risk. If you are a woman with CD4+ >250 cells/mm3, or a man with CD4+ >400 cells/mm3, you should not begin taking VIRAMUNE unless you and your doctor have decided that the benefit of doing so outweighs the risk. Women, including pregnant women, with CD4+ cell counts >250 cells/mm3 are at the greatest risk.

Do not take VIRAMUNE if you have severe liver problems.

The dose of VIRAMUNE for adults is one 200-mg tablet daily for the first 14 days, followed by one 200-mg tablet twice daily. VIRAMUNE is always taken with other anti-HIV medications. The 14-day lead-in period is important because it can help reduce your chances of getting a potentially serious skin rash. If you have a skin rash during the first 14 days, immediately contact your doctor and do not increase your VIRAMUNE dose to twice a day. The total duration of the once daily lead-in dosing period should not exceed 28 days, at which point an alternative regimen may need to be started.

Other side effects that patients have experienced include nausea, fatigue, fever, headache, vomiting, diarrhea, abdominal pain, and myalgia. Changes in body fat may occur in patients receiving antiretroviral therapy. Immune reconstitution syndrome has been reported in patients treated with combination ARV therapy.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please see full Prescribing Information, including boxed WARNING, and Medication Guide for VIRAMUNE at www.viramune.com.

For more information, please visit http://us.boehringer-ingelheim.com and follow us on Twitter at http://twitter.com/boehringerus.

*Truvada is a registered trademark of Gilead Sciences, Inc.

New Game on Facebook Helps People with Diabetes Improve Everyday Behaviors

Mon, 14 June 2010 22:00:00 GMT

-HealthSeeker Players Can Enlist ‘Friends’ for Ongoing Support in Improving their Understanding and Management of Diabetes -

Ridgefield, CT, June 14, 2010 — A new game called HealthSeeker™ launched today to more than 400 million active users of Facebook®¹, with the goal of helping adults with specific lifestyle and nutritional challenges. While the benefits of the game are available to anyone, HealthSeeker specifically helps people with diabetes make more informed lifestyle decisions in an innovative way that complements their daily use of social media.

HealthSeeker is a unique online experience that combines a supportive social networking environment with important information on managing diabetes. The game utilizes the player's own Facebook friends as sources of inspiration and support along the road to better health. There are MISSIONS and ACTION STEPS to help players achieve several LIFESTYLE GOALS. The MISSIONS and ACTION STEPS that players select must be completed in order to advance in the game. The LIFESTYLE GOALS include eating healthier, achieving an optimal weight, lowering blood sugar levels and lowering cardiovascular risk factors. As ACTION STEPS are completed and players return to report their progress, they receive experience points and other awards for their achievements.

HealthSeeker is a unique collaboration between experts, advocates and industry partners who are on the front lines of diabetes care. It was developed by Diabetes Hands Foundation in collaboration with Joslin Diabetes Center, with support provided by Boehringer Ingelheim Pharmaceuticals, Inc.

"With HealthSeeker, we wanted to harness the Facebook phenomenon to help people with diabetes make necessary changes in their daily lives," said Manny Hernandez, president, Diabetes Hands Foundation, who has been living with diabetes since 2002. "I cannot overstate how important a source of support, information and inspiration social networking tools like this one can be for someone living with a chronic condition like diabetes."

Many people with diabetes struggle with the lifestyle changes that are needed to help manage their condition, such as adding more fiber, fruit and vegetables to their diets, or increasing their daily activity. HealthSeeker can help people with diabetes stay motivated by presenting simple, everyday steps to help them achieve their lifestyle goals.

"As a clinician who has been treating people with diabetes for more than 30 years, I can tell you that food is often the most frustrating area of concern for people with the condition," said Richard Jackson, MD, an endocrinologist and director of medical affairs, healthcare services, Joslin Diabetes Center and assistant professor of medicine, Harvard Medical School. "We hope this novel and engaging game will break down some of the barriers that prevent people with diabetes from building a successful lifestyle approach to their condition."

HealthSeeker can be accessed free of charge at www.healthseekergame.org. The game was designed by Ayogo Games, Inc.

Support from Boehringer Ingelheim Pharmaceuticals, Inc. for HealthSeeker is part of a global initiative that includes a collection of creative online diabetes games reflecting the company’s commitment to transforming one way that people learn, through innovative education.

About Diabetes
Approximately 27² million Americans and 285 million people worldwide2 have diabetes. Type 2 diabetes is the most common type, accounting for more than 90 percent of all diabetes cases in the developed world.³ Each year, more than 231,000 people in North America² and more than 3.96 million people worldwide die from diabetes and its complications2 – a number which is expected to increase by more than 50 percent over the next decade.³ Diabetes is a chronic disease that occurs when the body either does not properly produce, or use, the hormone insulin.⁴

For more information, please visit http://us.boehringer-ingelheim.com
On Twitter: twitter.com/boehringerus.

About Diabetes Hands Foundation (DHF)
Diabetes Hands Foundation is a 501(c)(3) nonprofit dedicated to connecting people touched by diabetes (those with diabetes, as well as their loved ones) and raising diabetes awareness.

Through its online communities (TuDiabetes.org in English, EsTuDiabetes.org in Spanish) and its other social media channels, DHF offers support and information to nearly 200,000 people every month.

Since 2008, DHF has developed pioneering diabetes awareness programs such as Word In Your Hand™, Drawing Diabetes, No-Sugar Added Poetry, Making Sense of Diabetes and The Big Blue Test.

For more information, please visit www.diabeteshandsfoundation.org
On Facebook: www.facebook.com/diabetesHF
On Twitter: twitter.com/diabetesHF
On YouTube: www.youtube.com/DiabetesHands

DHF does not endorse products or services.

About Joslin Diabetes Center
Joslin Diabetes Center is the world's preeminent diabetes research and clinical care organization. Joslin is dedicated to ensuring that people with diabetes live long, healthy lives and offers real hope and progress toward diabetes prevention and a cure. Founded in 1898 by Elliott P. Joslin, M.D., Joslin is an independent, nonprofit institution affiliated with Harvard Medical School.

For more information, please call 1-800-JOSLIN-1 or visit www.joslin.org
For research and clinical news at Inside Joslin: www.joslin.org/news/inside_joslin.html
On Facebook: www.facebook.com/joslindiabetescenter
On Twitter: twitter.com/JoslinDiabetes

Joslin Diabetes Center does not endorse products or services.

About Ayogo Games, Inc.
Ayogo Games, Inc. is a Vancouver-based studio that creates innovative gaming experiences enjoyed on social networks (Facebook, MySpace, Bebo, etc.), and mobile platforms (iPhone, Android, BlackBerry, etc.). We help content creators and rights holders build new revenue streams and new audiences for their content.

For more information, please visit: www.ayogo.com
For CEO Michael Fergusson’s Social Game Design Blog: www.ayogo.com/social-game-design
On Facebook: www.facebook.com/ayogo

On Twitter: twitter.com/ayogogames

References

Facebook. Statistics. Press Room, 2010. Available at: http://www.facebook.com/press/info.php?statistics. Accessed on: May 6th, 2010.
International Diabetes Federation. Diabetes Atlas. 4th edn. Brussels: International Diabetes Federation, 2009..
World Health Organization. Fact Sheet No. 312: What is Diabetes? Available at: http://www.who.int/mediacentre/factsheets/fs312/en/. Accessed on: February 4, 2009.
International Diabetes Federation. Diabetes Atlas. 3rd edn. Brussels: International Diabetes Federation, 2006.

DRIVE4COPD Makes Its Mark on American Health

Fri, 11 June 2010 22:00:00 GMT

- 100,000 People Screened for COPD Risk since February Launch -

Ridgefield, CT, June 11, 2010 —In just four months since its launch, DRIVE4COPD has already encouraged more than 100,000 people to be screened to see if they may be at risk for chronic obstructive pulmonary disease (COPD). The country’s newest health initiative that aims to raise awareness of COPD in the hopes that people will talk to their doctor and get diagnosed instead of suffering in silence. Currently, half of the estimated 24 million Americans who may have COPD remain undiagnosed and untreated, and most are not diagnosed until they have lost half their lung function.

“Many people confuse common COPD symptoms, like shortness of breath or a cough that won’t go away, with normal signs of aging and wait too long to see a doctor,” said [Brian Carlin, MD, Pulmonary and Critical Care Medicine, Drexel University School of Medicine]. “Hopefully these first 100,000 people will be an inspiration for others to recognize the importance of finding out if they are risk.”

To determine one’s risk for COPD, people aged 35 and older can log onto DRIVE4COPD.COM and answer five brief questions on a validated screening tool. If the screener indicates they may be at risk for COPD, the results should be printed and brought to their doctor to discuss.

Spearheaded by campaign ambassador and NASCAR Nationwide Series™ driver Danica Patrick, the DRIVE4COPD Race Team is in a year-long competition to screen the most people who may be at risk for COPD. The Race Team includes Emmy-nominated actor Jim Belushi, Olympic Gold Medalist Bruce Jenner, Grammy Award-winning country music star Patty Loveless and Pro Football great Michael Strahan. Each has a loved one who struggled with the disease.

“I couldn’t believe it when I heard COPD was the fourth leading cause of death – it kills more people each year than diabetes and breast cancer combined,” said Patrick, whose grandmother died of emphysema, a form of COPD. “I’m so grateful that my fans and their families have taken it seriously, taken the screener, and are helping to spread the word about DRIVE4COPD.”

In addition to online screenings, the DRIVE4COPD campaign includes “Pit Stop” events across the country at NASCAR®-sanctioned races, state fairs, country music festivals and major sporting events. Log onto DRIVE4COPD.COM to find upcoming Pit Stop locations.

DRIVE4COPD is led by Boehringer Ingelheim along with a powerful coalition of organizations including the American Lung Association, COPD Foundation and NASCAR®. DRIVE4COPD is the Official Health Initiative of NASCAR.

“It’s inspiring to collaborate with so many great people dedicated to raising awareness of this progressive and deadly disease,” said Chris Barrett, Senior Vice President at Boehringer Ingelheim Pharmaceuticals, Inc. “Every screener taken means another person may get the help they need by sharing their results with their healthcare provider.”

Winner of Ultimate NASCAR® Weekend Announced
Of the 100,000 Americans who have been screened to date, one lucky participant won the Ultimate NASCAR® Weekend at the 2010 NASCAR Sprint Cup Series™ "Coke Zero 400," which takes place July 2-4, 2010. Chicago resident Karl R. took the screener at DRIVE4COPD.COM and is going to be taking his family with him to the race.

“I wasn’t really aware of COPD before I took the screener,” said Karl. “You don’t hear about it as much as you hear about heart disease or cancer, but I’m glad to know that right now I am not at a high risk for COPD.”

New Prizes Announced
People who take the five-question screener now have the option of entering to win one of two new prizes:

The Ultimate NASCAR® Weekend is a four-day/three-night trip for the winner and a guest, including tickets to the 2011 Daytona 500, plus VIP passes*.
CMA Awards Trip Package: a three-day/two-night trip for the winner and a guest to attend the 2010 CMA Awards in Nashville, TN.**

More details about the complete winner’s packages can be found at DRIVE4COPD.COM.

About COPD
Both types of chronic obstructive pulmonary disease (COPD) – chronic bronchitis and emphysema – make it harder to breathe because less air is able to flow in and out of the lungs.

As many as 24 million Americans may have COPD – even those who haven’t smoked in years – and half of them remain undiagnosed. COPD is the fourth leading cause of death in the United States. It kills one person every four minutes and more people each year than breast cancer and diabetes combined.

Common symptoms of COPD include coughing, with or without mucus, or shortness of breath. These symptoms are often confused with normal signs of aging. As COPD progresses, symptoms tend to get worse and more damage occurs in the lungs. Breathing gradually becomes more difficult until people with COPD feel like they are inhaling and exhaling through a small straw.

Because of its gradual onset, many patients are not diagnosed until they are hospitalized or require emergency care to treat the disease. By that time, their lungs may have already been critically damaged and they avoid activities that they used to enjoy because they become short of breath more easily. As such, COPD changes not only the life of the diagnosed person, but also of surrounding family and friends.

COPD can be managed to help people live and breathe easier. Early diagnosis of COPD is critical, as lung damage is not reversible but is treatable. Proper management of COPD is important to help patients breathe better, remain independent, prevent complications and exacerbations, and improve quality of life. Lifestyle changes like staying active and quitting smoking can help improve symptoms. Yet even when people are diagnosed with COPD, only half of them are prescribed treatment to help them breathe better.

COPD Screener
Given the underdiagnosis of COPD, there was a need for a reliable, self-scored questionnaire to identify individuals at risk for COPD. The development of this questionnaire began with a list of items identified for inclusion by a clinician working group of 10 pulmonologists and primary care physicians. A national survey of nearly 700 patients at 12 practitioner sites found five items that positively predicted airflow obstruction: breathlessness, productive cough, activity limitation, smoking history and age. These five items became the COPD Population Screener™. The study validating this screener was published in April 2008 [Martinez, F. J., Raczek, A. E., Seifer, F. D., Conoscenti, C. S., Curtice, T. G. & D'Eletto, T., et al. Development and Initial Validation of a Self-Scored COPD Population Screener Questionnaire (COPD-PS). COPD: Journal of Chronic Obstructive Pulmonary Disease, 5:2, 85-95].

DRIVE4COPD Partnering Organizations
Boehringer Ingelheim Pharmaceuticals, Inc., the founding sponsor of the campaign, has joined forces with a cross-section of organizations on DRIVE4COPD to bring COPD to the forefront including:

American Lung Association
Now in its second century, the American Lung Association is the leading organization working to save lives by improving lung health and preventing lung disease. With your generous support, the American Lung Association is "Fighting for Air" through research, education and advocacy. For more information about the American Lung Association or to support the work it does, call 1-800-LUNG-USA (1-800-586-4872) or visit www.lungusa.org.

COPD Foundation
The COPD Foundation is a not-for-profit organization created in 2004, and has become the COPD community’s forefront organization, driven by the individuals affected by COPD, that has addressed educational, research and advocacy issues that concern the community in order to improve the quality of life for the 24 million Americans affected by COPD. For more information about the COPD Foundation and its programs, call the C.O.P.D. Information Line at 1-866-316-COPD (2673) or visit the website at www.copdfoundation.org.

NASCAR
The National Association for Stock Car Auto Racing, Inc. (NASCAR) is the sanctioning body for one of North America's premier sports. NASCAR races are broadcast in more than 150 countries and 20 languages. NASCAR fans are the most brand-loyal in all of sports, and as a result more Fortune 500 companies participate in NASCAR than any other sport.

For more information, please visit http://us.boehringer-ingelheim.com.

*No Purchase Necessary. Program starts 5/2/10 & ends 12/1/10. Open only to legal residents of the 50 United States (including DC) who are 35 years of age or older at the time of entry. This Program is void in Puerto Rico & where prohibited. For official rules & complete details visit www.DRIVE4COPD.com. NASCAR, Inc. is not a sponsor of this promotion.

**No Purchase Necessary. Program starts 5/17/10 & ends 9/1/10. Open only to legal residents of the 50 United States (including DC) who are 35 years of age or older at the time of entry. This Program is void in Puerto Rico & where prohibited. For official rules & complete details visit www.DRIVE4COPD.com.

©2010 Boehringer Ingelheim Pharmaceuticals, Inc. All rights reserved.
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Zantac Teams with Travel Channel for “Beat the Heat” Tour

Tue, 25 May 2010 22:00:00 GMT

Ridgefield, CT, May 25, 2010 — Zantac®, a trusted name in heartburn relief, is teaming up with the Travel Channel to bring its “Beat the Heat” tour to cities nationwide this summer. The tour will kick off at Marc’s Great American Rib Cook-Off and Music Festival in Cleveland, Ohio over Memorial Day weekend and will make its final stop in Yarmouth, Maine on July 18.

In the Zantac interactive exhibit, attendees will be able to virtually meet Adam Richman, star of Travel Channel’s “Man v. Food”, by standing in front of a green screen environment for a customized photo with the star, along with a plate of heartburn-inducing food. Participants will then step into the Zantac Cool Zone, a retreat that will relax and entertain them with cool mist fans and “Man v. Food” episodes available for their viewing pleasure. Zantac team members will distribute coupons, product samples and other giveaways to attendees. And finally, visitors will have the opportunity to register at internet kiosks for their chance to win the “Beat the Heat” Sweepstakes where one lucky winner will win a 7-day / 6-night trip for two to their choice of two destinations previously featured on “Man v. Food”, including exciting destinations such as New York City and San Francisco.

Travel Channel is providing an overlay to the Zantac tour that allows consumers to take-on their own “Man v. Food” challenge. An emcee will call the shots as fans attempt to beat the clock and win bragging rights and a “Man v. Food” t-shirt.

The full tour schedule includes the following events:

May 28-31, 2010	Marc’s Great American Rib Cook-Off and Music Festival, Cleveland, OH
June 4-6, 2010	Troy Strawberry Festival, Troy, OH
June 11-13, 2010	Taste of Charlotte, Charlotte, NC
June 18-20, 2010	Belleville National Strawberry Festival, Belleville, MI
June 24-27, 2010	Summerfest, Milwaukee, WI
June 29-July 4, 2010	Taste of Chicago, Chicago, IL
July 10-11, 2010	Taste of Buffalo, Buffalo, NY
July 16-18, 2010	Hannaford Supermarket and Pharmacy, US Route 1, Yarmouth, ME

“Zantac is a natural fit at these events as it allows event-goers to enjoy the various foods offered at these great events, without worrying about the threat of heartburn,” commented Linnea Teetsel, Senior Brand Manager Zantac, Boehringer Ingelheim Consumer Health Care.

About Boehringer Ingelheim Consumer Health Care
Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, CT, is the largest U.S. subsidiary of Boehringer Ingelheim Corporation (Ridgefield, CT) and a member of the Boehringer Ingelheim group of companies.

For more information, please visit http://us.boehringer-ingelheim.com and follow us on Twitter.com/BoehringerUS.

Boehringer Ingelheim to present new data regarding its investigational compound BIBW 2992 in head and neck cancer and non-small cell lung cancer

Thu, 20 May 2010 22:00:00 GMT

-Preliminary findings support continued development of BIBW 2992 in these tumor types -

Ridgefield, CT, May 20, 2010 —Boehringer Ingelheim will announce preliminary data in the areas of head and neck cancer and non-small cell lung cancer (NSCLC) for one of the company’s investigational compounds, BIBW 2992. These data will be presented at the 2010 Annual Meeting of the American Society of Clinical Oncology (ASCO) meeting in Chicago. BIBW 2992 is an orally-administered, small molecule under development that irreversibly inhibits the epidermal growth factor receptor (EGFR/HER1) and human epidermal receptor 2 (HER2) tyrosine kinases.

BIBW 2992 data in head and neck cancer1
New data will report preliminary best response analysis for 74/109 patients from an ongoing Phase 2 study of 124 patients with metastatic or recurrent squamous cell carcinoma of the head and neck (SCCHN) who did not respond to platinum-containing therapy. In this study, patients were initially randomly assigned to either BIBW 2992 or cetuximab. Twenty-two percent of the 34 patients receiving BIBW 2992 experienced reduction in tumor size (measured as partial response), compared to 13 percent of the 40 patients receiving cetuximab. Preliminary safety analyses revealed diarrhea and skin-related adverse events as the most common adverse events associated with BIBW 2992.

“Metastatic head and neck cancer has a very poor prognosis, and patients are in desperate need for new treatment options,” says Tanguy Y. Seiwert, M.D., lead investigator of the trial, University of Chicago Medical Center. “These findings, while preliminary, are encouraging and warrant further investigation of BIBW 2992 in head and neck cancer.”

BIBW 2992 data in NSCLC2
In LUX-Lung 2, a Phase 2 study, 444 patients with advanced adenocarcinoma of the lung who were untreated or progressed after one course of chemotherapy were tested for common EGFR mutations. Of the patients who tested positive for EGFR mutations, 129 patients received treatment with BIBW 2992. The overall response rates (primary endpoint) for patients with the common EGFR mutations deletion 19 and L858R were 62 percent and 52 percent, respectively. Median progression-free survival (secondary endpoint) was estimated to be 12 months for the overall group. The most common drug-related adverse events were diarrhea and rash (reported in 95% for each), with 18 percent and 19 percent of patients experiencing grade 3 symptom severity, respectively.

LUX-Lung 2 is part of the comprehensive LUX-Lung clinical trial program evaluating BIBW 2992 in various patient populations, all with NSCLC. This LUX-Lung trial program currently comprises five trials.

“Boehringer Ingelheim is using scientific advances to develop a range of targeted therapies in areas of medical need, including various solid tumors and hematological cancers,” said Dr. Andree Amelsberg, Executive Director and Medical Leader Oncology, Boehringer Ingelheim Pharmaceuticals, Inc. “We are pleased with the preliminary results of these Phase 2 studies, which support continued development of BIBW 2992 as a potential new treatment option for head and neck cancer and non-small cell lung cancer.”

About head and neck cancer
Head and neck cancer can occur in over 30 different places in any of the tissues or organs in the head and neck3 and is the sixth most frequently occurring cancer worldwide.4 Most head and neck cancers are squamous cell carcinomas,5 over 90 percent of which express EGFR,6 which is critical for tumor growth.7

About lung cancer
Lung cancer is the world’s most common cancer and kills more people than any other cancer. In 2009, approximately 219,440 new cases of lung cancer were diagnosed in the United States, with 159,390 Americans dying from the disease.8 NSCLC is the most common form of lung cancer, accounting for about 85 percent of all lung cancers.8

About Boehringer Ingelheim in Oncology
Building on scientific expertise and excellence in the fields of pulmonary and cardiovascular medicine, metabolic disease, neurology, virology and immunology, Boehringer Ingelheim has embarked on a major research program to develop innovative cancer drugs. Working in close collaboration with the international scientific community and a number of the world’s leading cancer centers, Boehringer Ingelheim is committed to discovering and developing novel cancer treatments. The current focus of research includes compounds in three areas: angiogenesis inhibition, signal transduction inhibition and cell-cycle kinase inhibition.

BIBW 2992 is currently in Phase 3 clinical development in NSCLC, and was granted Fast Track designation for a treatment indication in NSCLC after prior treatment with an EGFR-tyrosine kinase inhibitor (TKI) by the U.S. Food and Drug Administration.

Apart from BIBW 2992, Boehringer Ingelheim’s late stage oncology portfolio includes BIBF 1120, also in Phase 3 development for the treatment of patients in two different indications, advanced NSCLC and ovarian cancer. The ongoing LUME-Lung Phase 3 clinical trial program is investigating BIBF 1120 in combination with standard second-line chemotherapy treatments for patients with advanced NSCLC.

BIBF 1120 is an investigational, orally-administered compound that simultaneously inhibits fibroblast growth factor receptor (FGFR), platelet-derived growth factor receptor (PDGFR) and vascular endothelial growth factor receptor (VEGFR), three of the receptor tyrosine kinases (RTKs) shown to aid in the regulation of angiogenesis. The formation and maintenance of new blood vessels (angiogenesis) play a critical role in tumor growth and metastasis.

In the area of cell-cycle kinase inhibition, Boehringer Ingelheim is developing inhibitors of polo-like kinase 1 (Plk1). Plk1 is a key regulator of cell division (mitosis) and is known to be overexpressed in a wide variety of tumors. The company’s compound, BI 6727, is currently being investigated in several Phase 2 studies, including acute myeloid leukemia (AML), NSCLC and Urothelial cancers.

In 2009, Boehringer Ingelheim posted net sales of US $17.7 billion (12.7 billion euro) while spending 21 percent of net sales in its largest business segment, Prescription Medicines, on research and development.

For more information, please visit http://us.boehringer-ingelheim.com and follow us on Twitter at http://twitter.com/boehringerus.

References

Seiwert TY et al. “BIBW 2992 versus cetuximab in patients with metastatic or recurrent head and neck cancer (SCCHN) after failure of platinum-containing therapy with a cross-over period for progressing patients: Preliminary results of a randomized, open-label Phase II study.” Oral Presentation. 7 June 2010, Session Time: 8:00 a.m.–12:00 p.m. Abstract #5501.
Yang CH et al. “A Phase II study of BIBW 2992 in patients with adenocarcinoma of the lunch and activating EGFR mutations (LUX-Lung 2).” Poster Discussion Presentation. 7 June 2010, Session Time: 8:00 a.m.–12:00 p.m. Abstract #7521.
MacMillan Cancer Support. http://www.macmillan.org.uk/Cancerinformation/Cancertypes/Headneck/Aboutheadnec kcancers/Headneckcancers.aspx. Last accessed 7 May 2010.
Hunter KD et al. Profiling early head and neck cancer. Nat Rev Cancer. 2005 Feb; 5 (2): 127-35.
Lutzky VP. Biomarkers for Cancers of the Head and Neck. Clinical Medicine: Ear, Nose and Throat, 2008:1.
Grandis JR and Tweardy DJ. Elevated levels of transforming growth factor alpha and epidermal growth factor receptor messenger RNA are early markers of carcinogenesis in head and neck cancer. Cancer Res., 1993. 53:3579–84.
Normanno N et al. The ErbB receptors and their ligands in cancer: an overview. Current Drug Targets. 2005. May;6(3):243-47.
Cancer Trends Progress Report – 2009/2010 Update, National Cancer Institute, NIH, DHHS, Bethesda, MD, April 2010, http://progressreport.cancer.gov.

Boehringer Ingelheim Announces New Data on Flibanserin in Pre-Menopausal Women with Hypoactive Sexual Desire Disorder

Tue, 18 May 2010 22:00:00 GMT

- New analyses from pivotal Phase III flibanserin trials presented today -

Ridgefield, CT, May 18, 2010 —Data from pivotal Phase III clinical trials demonstrate that a higher proportion of pre-menopausal women with Hypoactive Sexual Desire Disorder (HSDD) receiving flibanserin 100mg reported both an improvement in their condition and a meaningful benefit from their treatment, compared to placebo. Flibanserin is an investigational compound being developed by Boehringer Ingelheim Pharmaceuticals, Inc. for the treatment of HSDD in pre-menopausal women. HSDD is a persistent or recurrent decrease or lack of sexual desire that causes distress for the patient, may put a strain on relationships with partners, and is not due to the effects of a substance, including medications, or another medical condition.

The findings, presented at the 58th Annual Clinical Meeting of the American College of Obstetricians and Gynecologists in San Francisco, include data from a pre-specified pooled analysis of two pivotal North American trials (DAISY® and VIOLET®) assessing flibanserin 100mg in pre-menopausal women suffering from HSDD.

“These new data offer a unique perspective on the effects of flibanserin 100 mg from the patient’s point of view. Not only did pre-menopausal women with HSDD report feeling an improvement in their symptoms of low desire and associated distress when taking flibanserin, but they also reported that this change had a meaningful benefit to them,” said John Thorp, MD, study investigator, Professor of Obstetrics and Gynecology, University of North Carolina Medical School.

These findings add to data from the primary and secondary endpoint analysis of flibanserin pivotal trials. According to the pre-specified pooled analysis of women who completed 24 weeks of treatment, flibanserin 100mg showed statistically significant improved measures of sexual desire, overall sexual functioning, distress associated with low sexual desire, and the number of satisfying sexual events (SSE), compared with placebo.

“HSDD is an under-recognized and often misunderstood condition that can take a toll on women,” said Peter Piliero, MD, executive director, Medical Affairs, Boehringer Ingelheim Pharmaceuticals, Inc. “We are committed to advancing flibanserin’s development to help understand and find a treatment for women affected by this distressing medical condition.”

North American Phase III Trial Results
Patient Perspective Analysis
The pooled analysis included 1,378 pre-menopausal women with HSDD treated with either flibanserin 100 mg or placebo for 24 weeks. The women evaluated their overall improvement in “bothersome decreased sexual desire” using the Patient’s Global Impression of Improvement (PGI-I), which is a 7-point scale from 1 (very much improved) through 4 (no change) to 7 (very much worse). By 24 weeks, 48.3 percent of women receiving flibanserin and 30.3 percent of women receiving placebo reported feeling very much improved, much improved or minimally improved (p<0.0001).

In addition, more women in the flibanserin group versus placebo reported experiencing a meaningful benefit from the study medication (40.5 percent versus 25.2 percent, respectively; p<0.0001), using a single-question Patient Benefit Evaluation (Overall, do you believe that you have experienced a meaningful benefit from the study medication?).

Analysis of Completers
The pooled analysis included 971 (flibanserin 100 mg qhs: 450; placebo: 521) pre-menopausal women who completed the 24-week trials. In that analysis, flibanserin 100mg significantly increased the frequency of SSE versus placebo (increase of 2.1 events vs. 0.9 events, respectively; p<0.0001) over the 24-week study period. The analysis also found that, compared with placebo, flibanserin 100 mg showed statically significant improved measures of sexual desire using an electronic daily diary or eDiary (primary endpoint) and on the Female Sexual Function Index (FSFI) desire domain (secondary endpoint). Compared with placebo, flibanserin also showed statistically significant improved sexual functioning (as measured by the FSFI total score), and distress related to low sexual desire (based on the Female Sexual Distress Scale-Revised, FSDS-R, total score), which were secondary endpoints.

The FSFI and FSDS-R desire scores are independently developed and validated tools that provide additional measurement of changes in desire over a four-week recall period. The FSFI is a 19-item self-administered questionnaire composed of six domains (desire, arousal, lubrication, orgasm, satisfaction, and pain). The FSDS-R is a 13-item self-administered questionnaire. The total score ranges from zero to 52, with the higher scores indicating more sexual distress.

Pivotal Trials Safety Data
The most commonly reported adverse events (AEs) with flibanserin 100mg in the pivotal North American trials were mild to moderate and emerged during the first 14 days of treatment. These AEs reported by more women on flibanserin than on placebo included somnolence (daytime sleepiness), dizziness, fatigue, anxiety, dry mouth, nausea and insomnia. The majority of these AEs resolved with continued treatment. About 15 percent of women on flibanserin 100mg and seven percent of women on placebo discontinued treatment due to AEs.

About Flibanserin
Flibanserin is an investigational compound being developed by Boehringer Ingelheim for the treatment of HSDD in pre-menopausal women. Pooled data from pivotal phase III trials demonstrated that flibanserin 100mg increased the number of satisfying sexual events (SSE) and sexual desire while decreasing the distress associated with HSDD. The most commonly reported adverse events (AEs) with flibanserin 100mg were mild to moderate and emerged during the first 14 days of treatment. These AEs reported by more women on flibanserin than on placebo included somnolence (daytime sleepiness), dizziness, fatigue, anxiety, dry mouth, nausea and insomnia. The majority of these AEs resolved with continued treatment. About 15 percent of women on flibanserin 100mg and seven percent of women on placebo discontinued treatment due to AEs.

About Hypoactive Sexual Desire Disorder
Low sexual desire is the most commonly reported female sexual complaint. Approximately one in 10 women report low sexual desire with associated distress, which may be HSDD. HSDD is a form of female sexual dysfunction (FSD) and has been recognized as a medical condition for more than 30 years. As defined by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR), HSDD is the persistent or recurrent lack (or absence) of sexual fantasies or desire for any form of sexual activity causing marked distress or interpersonal difficulty and not better accounted for by another disorder (except another sexual dysfunction), direct physiological effects of a substance (including medications), or a general medical or psychiatric condition. Generalized, acquired HSDD is not limited to certain types of stimulation, situations or partners, and develops only after a period of normal functioning. There is an unmet need for women as there is no FDA-approved treatment for HSDD. It can affect women of all ages and at any stage of life.

The Boehringer Ingelheim group is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 142 affiliates in 50 countries and more than 41,500 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel products of high therapeutic value for human and veterinary medicine.
In 2009, Boehringer Ingelheim posted net sales of US $17.7 billion (12.7 billion euro) while spending 21% of net sales in its largest business segment, Prescription Medicines, on research and development.

For more information, please visit http://us.boehringer-ingelheim.com

When it Comes to Sparking a Woman’s Sexual Desire, Most Men – and Even Women – May Not Know Where to Start

Wed, 12 May 2010 22:00:00 GMT

- Actress Lisa Rinna kicks off campaign highlighting connection between brain, body and sexual desire -

Washington, D.C., May 12, 2010 —When it comes to sex, more than half of men and women don’t recognize the brain as an important female sexual organ, according to a new survey.*

“The root of a woman’s desire is complex, but it is thought to start with her brain. The brain is the center for thoughts and emotions, but it is also home to a complex system of nerves, hormones and other chemicals that can affect sexual desire,” said Laura Berman, LCSW, Ph.D., and sex and relationship expert.

Interestingly, the survey revealed that women and men’s feelings about sex and sexual desire are more alike than people may think, as they both agree that sexual health is important for a woman’s overall health and well being. Yet, while most women surveyed would be concerned if they experienced, and most men would be concerned if their partner experienced, a decrease in sexual desire, less than half of both women and men have ever discussed these issues with their partner.

Today, the Society for Women’s Health Research (SWHR), along with actress and TV personality Lisa Rinna, launched “Sex Brain Body: Make the Connection,” a new educational campaign about female sexual health, particularly about the role the brain is thought to play in female sexual desire.

“As a woman, wife and mother, I know that women’s sexual desire can fluctuate. For some women that’s normal, but for others it may be something more,” Rinna said. “Everyone is entitled to a healthy sex life. That’s why I’m encouraging women to learn more about their sexual health and the brain’s potential role in desire, so they can talk more openly about it with a partner and health care provider. By visiting www.SexBrainBody.com, I want to empower women to learn more about their sexual health and better understand sexual desire.”

Experts believe that chemicals in the brain may play a role in sexual response, impacting a woman’s sexual desire. Women and men surveyed believe that desire is important for a healthy sex life, and that a decline in a woman’s desire would be distressing to the woman. Yet, few people realize that a lack of sexual desire accompanied by distress might be something more than stress from a demanding career or family commitments. It may be a medical condition known as Hypoactive Sexual Desire Disorder, or HSDD.

By visiting www.SexBrainBody.com, women can learn more about HSDD, as well as find helpful tips for starting what may be an uncomfortable conversation with their partners or health care providers about their sexual health and any issues they may be experiencing.

“For 20 years, SWHR has provided resources and knowledge to empower women to take control of their health. We are proud to be supporting this campaign to help women understand their sexual health and give them the confidence to discuss their needs,” said Phyllis E. Greenberger, M.S.W., President and CEO of SWHR in Washington, D.C.

Survey Findings
The “Sex Brain Body: Make the Connection” survey included 1,300 women ages 30 to 55 years and 1,129 men ages 30 to 65 years. The survey was designed to explore the attitudes and behaviors of women regarding their sexual health, as well as men’s perception of a woman’s sexual health.

Highlights of the survey include the following:

Nearly 75 percent of women report experiencing a lack of sexual desire at least occasionally, with 20 percent reporting a lack of desire frequently
Both women and men believe a woman’s lack of desire for sex would cause distress in a relationship (78 percent women, 63 percent men); more than half of women and men say that a lack of desire would have a negative impact on their relationship
Most women (roughly 60 percent) say they would discuss low sexual desire with their health care provider, yet only 14 percent have actually done so
More women would rather discuss other health topics such as allergies, skin care, hair loss and weight issues with their health care provider than talk about their sexual health
Women are seven times more familiar with erectile dysfunction (66 percent) than Hypoactive Sexual Desire Disorder (HSDD) (9 percent)

About “Sex Brain Body: Make the Connection”
“Sex Brain Body: Make the Connection” is an educational campaign meant to help women recognize the potential links between the brain, the body and sexual desire, so they can better understand and address their own sexual health. The campaign is sponsored by the Society for Women’s Health Research and content was developed with the support of a sponsorship from Boehringer Ingelheim Pharmaceuticals, Inc. To learn more about the sex-brain-body connection, visit www.SexBrainBody.com.

Low sexual desire is the most commonly reported female sexual complaint. Approximately one in 10 women reported low sexual desire with associated distress, which may be HSDD. HSDD is a form of female sexual dysfunction (FSD) and has been recognized as a medical condition for more than 30 years. As defined by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR), HSDD is the persistent or recurrent lack (or absence) of sexual fantasies or desire for any form of sexual activity causing marked distress or interpersonal difficulty and not better accounted for by another disorder (except another sexual dysfunction), direct physiological effects of a substance (including medications), or a general medical or psychiatric condition. Generalized, acquired HSDD is not limited to certain types of stimulation, situations or partners, and develops only after a period of normal functioning. There has been an unmet need for women as there is no FDA-approved treatment for HSDD. It can affect women of all ages and at any stage of life.

*About the Survey
A demographically representative national internet sample of 1,300 women between the ages of 30 and 55 and 1,129 men 30-65 were invited via email to participate in a 10-minute self-administered online survey. Women meeting any of the following criteria were eliminated from participating: had a full hysterectomy, currently take hormone replacement therapy, are post-menopausal and have already gone through menopause. The surveys were administered between February 8 and March 18, 2010. Data for these studies are tested for statistical difference at a confidence level of 95 percent. Data are weighted to reflect accurate representation of population.

About Society for Women’s Health Research
The Society for Women’s Health Research (SWHR), a national non-profit organization based in Washington, D.C., is widely recognized as the thought leader in research on sex differences and is dedicated to improving women’s health through advocacy, education, and research. SWHR was founded in 1990 by a group of physicians, medical researchers and health advocates who wanted to bring attention to the myriad of diseases and conditions that affect women uniquely. Women’s health, until then, had been defined primarily as reproductive health. Women were not routinely included in most major medical research studies and scientists rarely considered biological sex as a variable in their research.

About GfK Healthcare
GfK Healthcare (www.gfkhc.com) is the largest provider of fully integrated custom health care marketing research in the United States. With the broadest range of custom, syndicated and proprietary research offerings, paired with expertise in managed markets and sales force effectiveness, GfK Healthcare is equipped to meet a product’s needs across its life cycle, through flexible marketing research resources, responsive to clients’ evolving challenges. GfK Healthcare is part of the GfK Group.

For more information, please visit http://us.boehringer-ingelheim.com.

New Survey Finds Parents Need Help Encouraging Their Kids in Science

Mon, 10 May 2010 22:00:00 GMT

- Science Classroom on Wheels and Comprehensive Outreach Program Help Bridge Science Education Gap in Connecticut Schools and Encourage Family Involvement -

Ridgefield, CT, April 22 , 2010 —Boehringer Ingelheim Pharmaceuticals, Inc. and Connecticut United for Research Excellence, Inc. (CURE) today announced the launch of Boehringer Ingelheim Science Quest, a comprehensive initiative designed to bring hands-on science education directly to the Connecticut elementary schools that need it most.

A centerpiece of the effort is the Boehringer Ingelheim Science Quest mobile laboratory – a high-tech science classroom on wheels – that will visit priority school districts across the state. The program also will include tools and resources to facilitate science instruction in the classroom and encourage family involvement in science together at home.

The future of science education is a growing concern nationwide. According to the 2005 National Assessment of Educational Progress (NAEP) study, 37 percent of fourth grade students lacked a basic level of science proficiency. The need among Connecticut elementary school students is particularly acute, especially among those from lower-income families. In fact, a December 2009 report by the Connecticut State Department of Education found that fifth-grade students eligible for free and reduced-price meals scored 44 percent lower than non-eligible students in science performance on the 2008 Connecticut Mastery Test, a statewide education assessment test.

The Boehringer Ingelheim Science Quest mobile laboratory will bring science to life by creating an interactive and hands-on experience. Beginning at Shelter Rock Elementary school on May 17 in Danbury, the mobile laboratory will be making the first of its visits to Connecticut schools. Currently scheduled stops are the Mahan School in Norwich, the Park City Magnet School in Bridgeport, the Bernard School in New Haven, the Annie Fisher STEM Magnet School in Hartford, the Holmes School in New Britain, the Winthrop Elementary School in New London, and the Walsch School in Waterbury. The program will focus on Connecticut's priority school districts with the greatest academic need, as defined by the State Department of Education.

"For 125 years, Boehringer Ingelheim has been committed to improving the lives of patients and their families through the discovery of innovative science," said Jim Baxter, senior vice president of development at Boehringer Ingelheim. "A priority for Boehringer Ingelheim is to further science education and help extend the learning process into the homes and families of the students, in hopes of building a strong pipeline of scientists for the next 125 years. Through the Boehringer Ingelheim Science Quest initiative, we hope to encourage a passion for science in children beginning at an early age."

"CURE has focused on bringing the highest level of science education to students around Connecticut through a variety of education initiatives," said Paul Pescatello, president and CEO at CURE. "Programs like the Boehringer Ingelheim Science Quest are an investment in the future, helping prepare Connecticut children early on for careers in science and technology that will continue to drive our state's economic engine in the coming decades."

The official launch of the Science Quest mobile laboratory takes place today in Hartford. Dr. Thomas Steitz – the 2009 Nobel Prize Winner in Chemistry – and state officials will be on site to experience first-hand what the mobile laboratory will bring to schools around Connecticut. Dr. Steitz will lead a science experiment aboard the new vehicle.

On May 17, Boehringer Ingelheim and CURE will host the official dedication ceremony of the Science Quest mobile laboratory at Shelter Rock Elementary school in Danbury. Mark McQuillan, Connecticut Commissioner of Education, and executives from both Boehringer Ingelheim and CURE will be on hand for the ribbon cutting ceremony, followed by students conducting experiments on the mobile laboratory.

About BioScience Explorations
CURE BioScience Explorations, an award-winning service of CURE (Connecticut United for Research Excellence), includes three main programs:

Boehringer Ingelheim Science Quest focuses on improving elementary science education through a mobile laboratory and equipment loan program, together with related science curriculum and teacher training.
The CURE BioBus focuses on improving science education for students in grades 4-12 utilizing a mobile science laboratory, together with bioscience curricula and teacher training.
CURE BioConnection focuses on improving middle and high school science via an equipment loan program, together with relevant bioscience curricula and teacher training.

The programs, which are offered free of charge thanks to the continuing support of sponsors, have made more than 445 school visits, reached more than 60,000 students, and trained more than 775 teachers since 2001.

About CURE
CURE (Connecticut United for Research Excellence, Inc.) is a member-supported coalition of educational and research institutions, biotechnology and pharmaceutical companies, and other businesses supporting BioScience in the state of Connecticut. It is dedicated to promoting the growth and increased public understanding of biomedical research and science (http://curenet.org).

The Boehringer Ingelheim group is one of the world's 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 142 affiliates in 50 countries and more than 41,500 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel products of high therapeutic value for human and veterinary medicine.

For more information, please visit http://us.boehringer-ingelheim.com.

New Boehringer Ingelheim Science Quest Mobile Laboratory Brings Hands-On Science Education to Priority Connecticut Elementary Schools

Thu, 22 Apr 2010 22:00:00 GMT

- Nearly all science teachers wish their students’ parents had more opportunities to engage in science with their children, and many parents admit they need help -

Arlington, VA, and Ridgefield, CT, May 10, 2010 — A new survey announced today finds the vast majority (94%) of science teachers wish their students’ parents had more opportunities to engage in science with their children. However, more than half (53%) of parents of school-aged children admit that they could use more help to support their child’s interest in science. The survey was conducted by the National Science Teachers Association (NSTA) and Boehringer Ingelheim Pharmaceuticals, Inc., among a sample of 500 science teachers and 506 parents, including 406 parents of school-aged children.

While science teachers agree (98%) that parental involvement is important for children’s interest in science, the survey shows it to be among the subjects parents are least comfortable discussing with their kids. In fact, barely half (51%) of parents say they are “very familiar” with what their children are learning in science and only 15% cited it as the subject they feel “most comfortable” discussing with them, compared to 33% for language arts and 28% for math. Approximately seven in 10 parents say they are “very familiar” with what their children are learning in language arts (71%) and math (69%).

“Science education has been identified as a national priority, but science teachers can’t do the job on their own. They need the help and support from key stakeholders, especially parents,” said Francis Eberle, NSTA executive director. “We know that family involvement is important, and parents need help getting involved with their kids in a subject they may not feel comfortable with themselves. We must continue to find ways to break down the walls of the classroom and encourage learning together among families.”

The future of science education is a growing concern nationwide, with leaders making a concerted effort to move American students from the middle to the top of the pack in science achievement over the next decade. The gap is significant: Only 18% of American high school seniors perform at or above the proficient level in science, according to the most recent National Assessment of Educational Progress figures. International test scores show that US students lag significantly behind their peers in science.

When asked what they think prevents parents from encouraging their children’s interest in science, 77% of teachers say parents don’t feel comfortable talking about science with their children. Part of the problem may stem from lack of resources and community involvement. Half of science teachers say parents don’t have access to materials (52%) or community resources that encourage their children’s interest in science (49%). Parents agree, with nearly four out of five (78%) saying it would encourage their child’s interest if they had a place in their community where they could take their children to explore science.

“For 125 years, Boehringer Ingelheim has been committed to improving the lives of patients and their families through the discovery of innovative science,” said Jim Baxter, senior vice president of development at Boehringer Ingelheim. “A priority for Boehringer Ingelheim is to further science education and help extend the learning process into the homes and families of students, in hopes of building a strong pipeline of scientists for the next 125 years. Through the Boehringer Ingelheim Science Quest initiative, we hope to encourage a passion for science in children beginning at an early age.”

Boehringer Ingelheim and Connecticut United for Research Excellence, Inc., (CURE) recently launched Boehringer Ingelheim Science Quest, a comprehensive initiative designed to bring hands-on science education directly to the Connecticut elementary schools that need it most. A centerpiece of the effort is the Boehringer Ingelheim Science Quest mobile laboratory – a high-tech science classroom on wheels – that will visit priority school districts across the state. The program also will include tools and resources to facilitate science instruction in the classroom and encourage family involvement in science together at home.

Video tutorials featuring several simple and fun experiments families can do together at home can be found at: http://www.youtube.com/user/FamilyScienceQuest. More tips for parents on how to get engaged in science with their children can be found at: http://www.nsta.org/sciencematters.

Survey Methodology
The survey of teachers was conducted by Opinion Research Corporation via telephone from March 12-18, 2010, among a sample of 500 teachers in the continental United States using a telephone listing of households across the United States which have a teacher living there. The teachers qualified for participation if they taught science exclusively or taught science along with other subjects. If the sample had been randomly selected, the margin of error for the sample of 500 teachers would be +/-4.3%.

The parents’ survey was conducted via telephone from March 11-15, 2010, using the Random Digit Dialing omnibus services of Opinion Research Corporation. Completed interviews are weighted by four variables (age, sex, geographic region, and race) to ensure reliable and accurate representation of the total population, 18 years of age and older. The margin of error for the total sample of 506 parents is ±4.3% (weighted sample size: 715), and the margin of error for the total unweighted sample of 406 parents of school-aged children is ±4.8% (weighted sample size: 525).

About National Science Teachers Association and Science Matters
The National Science Teachers Association (NSTA) is the largest organization in the world committed to promoting excellence and innovation in science teaching and learning for all. The NSTA Science Matters initiative brings content, news, and information that supports quality science education to parents and teachers nationwide. Science Matters because the pipeline for our next generation of scientists, engineers, and technicians begins in the K-6 classroom. Quality elementary science lessons capture children’s attention when they are most open, most curious, and most naturally disposed to asking questions about the world around them. Young children who receive a strong foundation in science during their elementary school years do better in science in later grades. Engaging students in science at an early age also provides them with more information on career opportunities in science, technology, engineering and mathematics (STEM) careers.

For more information, please visit http://us.boehringer-ingelheim.com and follow us on Twitter at twitter.com/boehringerUS.

FDA maintains essential use status of Combivent® (ipratropium bromide and albuterol sulfate) Inhalation Aerosol through 2013

Tue, 13 Apr 2010 22:00:00 GMT

- COMBIVENT remains on the market and available to chronic obstructive pulmonary disease (COPD) patients -

Ridgefield, CT, April 13 , 2010 — Boehringer Ingelheim Pharmaceuticals, Inc. (BIPI) today announced that the U.S. Food and Drug Administration (FDA) has determined that the “essential use” status of Combivent® (ipratropium bromide and albuterol sulfate) Inhalation Aerosol will be effective through December 31, 2013. With this ruling, COMBIVENT will remain on the market and available to the more than two million chronic obstructive pulmonary disease (COPD) patients who rely on it as a bronchodilator.¹

As a result of the Montreal Protocol, the U.S. Food and Drug Administration (FDA) is phasing-out all remaining prescription oral pressurized metered dose inhalers (MDIs) that use chlorofluorocarbons (CFCs) by removing the “essential use” designation on these products. The FDA’s Final Rule, issued today, determines the timing for this phase-out for the seven remaining MDIs used to treat asthma and COPD.

BIPI has invested more than ten years researching and developing a CFC-free replacement product that will deliver the active ingredients in COMBIVENT and we are committed to working closely with the FDA on its development. The replacement product is in late-stage clinical development and the Company’s goal is that this new product will be available to patients prior to the December 31, 2013 effective date to allow ample time for a seamless transition.

“BIPI requested this status be maintained to allow uninterrupted patient care while we develop a chlorofluorocarbon (CFC)-free COMBIVENT product,” said Christopher Corsico, M.D., MPH, US medical director, Boehringer Ingelheim Pharmaceuticals, Inc. “As a leader in respiratory care, we are dedicated to providing optimal patient care, and are pleased the FDA ruling will allow continued access to COMBIVENT for patients.”

Uninterrupted patient care is important for patients with COPD. This population is particularly vulnerable because nearly 50% of patients who use COMBIVENT are 65 or older² and 84% of patients who use COMBIVENT often have other diseases requiring various treatments to stabilize their health.²

About COPD
COPD is a progressive, but preventable and treatable lung condition that is characterized by a restricted flow of air into and out of the lungs and loss of lung function over time. It includes chronic bronchitis, emphysema, or both.

COPD is the fourth-leading cause of death and the second-leading cause of disability in the United States, and is projected to become the third-leading fatal illness by 2020. Each year, COPD kills 120,000 Americans – that’s one death every four minutes.

The disease primarily affects current and former smokers and symptoms include shortness of breath, coughing (sometimes with phlegm or mucus) and wheezing. When most severe, COPD may even limit a person’s ability to perform simple tasks such as washing and dressing. The damage in the lungs caused by COPD is not reversible, but it is treatable.

About Combivent® (ipratropium bromide and albuterol sulfate) Inhalation Aerosol
COMBIVENT Inhalation Aerosol is indicated for use in patients with chronic obstructive pulmonary disease (COPD) on a regular aerosol bronchodilator who continue to have evidence of bronchospasm and who require a second bronchodilator.

Important Safety Information
COMBIVENT Inhalation Aerosol should not be used in patients who:

Are allergic to soya lecithin or related food products such as soybeans and peanuts
Are allergic to any of the ingredients in COMBIVENT Inhalation Aerosol or to atropine or other similar drugs

COMBIVENT Inhalation Aerosol can cause the narrowing of the airways to get worse (paradoxical bronchospasm) in some patients, which may be life threatening. Stop taking COMBIVENT Inhalation Aerosol and call your doctor or get emergency help if this happens.

COMBIVENT Inhalation Aerosol can cause serious allergic reactions. Symptoms include itching, swelling of the face, lips, tongue, or throat (which may cause difficulty in breathing or swallowing), skin rash, hives, bronchospasm (airway narrowing), or anaphylaxis. Stop taking COMBIVENT Inhalation Aerosol and call your doctor or get emergency help if you get any of these symptoms.

COMBIVENT Inhalation Aerosol can cause serious heart-related side effects, such as an increase in pulse, blood pressure, and/or related symptoms.

Deaths have been reported with similar inhaled medicines in asthma patients who use the medicine too much. Do not use COMBIVENT Inhalation Aerosol more often than your healthcare provider has directed.

Certain medical conditions may increase your risk of side effects.

Tell your healthcare provider about all your conditions and medicines you take, including if you:

Have narrow-angle glaucoma
Have prostate or urinary problems
Have a history of heart disease (e.g., reduced heart circulation, irregular heartbeat, and high blood pressure)
Have seizures
Have a thyroid disorder
Have diabetes
Have low potassium levels
Have kidney disease
Have liver disease
Are pregnant or planning to become pregnant or are breast-feeding
Are taking any heart medications or drugs to treat depression

Read the step by step Patient's Instruction for use before using this medicine.

Remember to vigorously shake your COMBIVENT Inhalation Aerosol for 10 seconds before each use or inhalation. Do not get the spray into your eyes.

For full prescribing information, please visit www.Combivent.com.

The Boehringer Ingelheim group is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 138 affiliates in 47 countries and approximately 41,300 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel products of high therapeutic value for human and veterinary medicine.

In 2008, Boehringer Ingelheim posted net sales of US $17 billion (11.6 billion euro) while spending approximately one-fifth of net sales in its largest business segment, Prescription Medicines, on research and development.

For more information, please visit http://us.boehringer-ingelheim.com.

References

Vector One National (VONA) Verispan, L.L.C.; Jan 2006 - Dec 2006. Vector One®: Total Patient Tracker from Verispan; January 2006 – December 2006. (DATA ON FILE WITH BI)
Harley C, et al., Use of Combivent Among Patients with Chronic Obstructive Pulmonary Disease (DATA ON FILE WITH BI)

Once-daily MIRAPEX ER now approved by FDA for both early and advanced Parkinson’s disease

Tue, 23 Mar 2010 22:00:00 GMT

- New treatment option for the nearly one million Americans affected by Parkinson’s disease -

Ridgefield, CT, March 23 , 2010 —Boehringer Ingelheim Pharmaceuticals, Inc., today announced that the U.S. Food and Drug Administration (FDA) has approved once-daily Mirapex ER® (pramipexole hydrochloride) extended-release tablets for the signs and symptoms of idiopathic Parkinson’s disease (PD), which includes early and advanced PD.¹ PD is the second most common chronic neurological disorder in older adults after Alzheimer’s.² Parkinson’s disease has no cure.³

“In a pivotal trial of patients with advanced Parkinson’s disease, MIRAPEX ER not only demonstrated significant symptom improvement, but also increased the number of hours during which people with advanced Parkinson’s disease had better mobility,” said Anthony Schapira, M.D., head of department and chairman of Clinical Neurosciences Specialties, The Institute of Neurology, University College London, London, UK. “With this approval, MIRAPEX ER may now help early as well as advanced PD patients with its convenient once-daily dosing schedule.”

Study findings showed that patients with advanced PD who were treated with MIRAPEX ER experienced superior symptom relief versus placebo. In addition, MIRAPEX ER demonstrated benefits similar to Mirapex® (pramipexole dihydrochloride) tablets, each versus placebo. Treatment with MIRAPEX ER also resulted in significant reductions of off-time (period of time when symptoms return) versus placebo.¹

“With the approval of MIRAPEX ER, we are hopeful that this once-daily treatment option may help ease some of the burden and obstacles that people with advanced Parkinson’s disease face on a daily basis,” said Albert Ros, executive vice president, Boehringer Ingelheim Pharmaceuticals, Inc.

Clinical Trials
The FDA approval of MIRAPEX ER for advanced PD patients was supported by efficacy data from one randomized, double-blind, placebo-controlled, 3-parallel group clinical study.¹ The clinical trial program involved 517 patients with advanced Parkinson’s disease who were treated with varying doses of MIRAPEX ER, MIRAPEX or placebo. The primary efficacy outcome was the adjusted mean change from baseline to week 18 in Unified Parkinson’s Disease Rating Scale (UPDRS) Parts II+III score with Part II averaged for on- and off-time and Part III assessed during on-time. The key secondary efficacy outcome was change in daily off-time at week 18. Maintenance of efficacy was analyzed at 33 weeks.⁴

In the trial, superiority of Mirapex ER® (pramipexole hydrochloride) extended-release tablets over placebo was demonstrated after 18 weeks of treatment, on both primary and key secondary efficacy endpoints.¹ In addition, maintenance of efficacy was shown in patients who completed 33 weeks of treatment. In the study, MIRAPEX ER demonstrated similar benefits as MIRAPEX, each versus placebo, in people with advanced PD.¹

The most common adverse events (incidence ≥ 5 percent and greater than placebo) in advanced PD concomitantly treated with levodopa were dyskinesia, nausea, constipation, hallucinations, headache, and anorexia.¹

*The Unified Parkinson’s Disease Rating Scale (UPDRS)
The Unified Parkinson’s Disease Rating Scale (UPDRS) is a comprehensive tool, which was developed to follow the longitudinal course of PD-related disability and impairment. The UPDRS II+III score was used as the primary efficacy endpoint in clinical trials. UPDRS Part II relates to activities of daily living and UPDRS Part III relates to motor symptoms. The UPDRS II+III score ranges from 0 (no disability) to 160 (worst disability).¹

About Parkinson’s disease
Parkinson’s disease is a progressive neurological disorder⁵ that affects nearly one million people in the U.S.⁶ It is the second most common chronic neurological disorder in older adults after Alzheimer’s.² Every nine minutes someone is diagnosed with Parkinson’s disease.⁶ Symptoms include tremor, muscle rigidity, slowed motion, shuffling gait, and a loss of facial expression.⁷ The symptoms vary from individual to individual, but become more severe over time.^7,2 Although promising research is being conducted, there is currently no cure for Parkinson’s disease.³

About Mirapex® (pramipexole dihydrochloride) tablets and Mirapex ER® (pramipexole dihydrochloride) extended-release tablets
MIRAPEX is indicated in the U.S. for the treatment of the signs and symptoms of idiopathic Parkinson’s disease in a three times daily immediate-release formulation.⁸ MIRAPEX ER is now approved in a once-daily, extended-release formulation to treat the signs and symptoms of idiopathic Parkinson’s disease, which includes early and advanced PD.¹ MIRAPEX is supported by more than twelve years of real-world experience in the treatment of Parkinson’s disease, with more than 16 million prescriptions written in the U.S. since its launch in 1997.^9,8

MIRAPEX ER is not indicated for the treatment of restless legs syndrome (RLS).

When taking MIRAPEX ER or MIRAPEX, hallucinations (unreal visions, sounds or sensations) may occur and you may sometimes feel dizzy, nauseated, faint or sweaty when you sit up or stand quickly.

The most common side effects in people taking MIRAPEX ER tablets for early PD are sleepiness, nausea and vomiting, constipation, dizziness, fatigue, hallucinations, dry mouth, muscle spasms, and edema (swelling of the feet and ankles). The most common side effects in people taking MIRAPEX ER tablets who have later-stage PD are abnormal movements, nausea, constipation, hallucinations, headache, and anorexia.

The most common side effects in people taking MIRAPEX for PD are nausea, dizziness, sleepiness, constipation, hallucinations, insomnia, muscle weakness, confusion, and abnormal movements.

Some patients taking certain medicines to treat PD, including MIRAPEX ER and MIRAPEX, have reported problems, such as gambling, compulsive eating, compulsive buying, and increased sex drive. If you or your family members notice that you are developing unusual urges or behaviors, talk to your doctor.

For full MIRAPEX ER or MIRAPEX prescribing information, please contact Boehringer Ingelheim’s Drug Information Unit at 1-800-542-6257.

For more information, please visit http://us.boehringer-ingelheim.com.

References

Mirapex ER® (pramipexole dihydrochloride) extended-release tablets Prescribing Information (Rev. March 2010).
Parkinson Primer: Overview of Parkinson Disease. National Parkinson Foundation. http://www.parkinson.org/NETCOMMUNITY/Page.aspx?pid=226&srcid=200 [Last accessed 2/18/10].
National Parkinson Foundation. Your Guide to Parkinson’s disease. 2005.
Schapira, A et al. Efficacy and safety of pramipexole extended-release for advanced Parkinson’s disease. Poster We-199, presented at 13th International Congress of Parkinson’s Disease and Movement Disorders (MDS), Paris, France, 09 June 2009).
Parkinson’s Disease: Hope Through Research. National Institute of Neurological Disorders and Stroke. Parkinson’s Disease. http://www.ninds.nih.gov/disorders/parkinsons_disease/detail_parkinsons_disease.htm#58003159 [Last accessed 2/18/10].
Obeso JA, Olanow CW, Nutt JG. Levodopa motor complications in Parkinson’s disease. Trends Neurosci. 2000; 23: S2-S7.
Kittle G. Parkinson Disease: A Basic Understanding. Parkinson Disease: What You and Your Family Should Know. 2006; 3-10.
Mirapex® (pramipexole dihydrochloride) Prescribing Information (Rev. April 2009).
IMS Data on file, Boehringer Ingelheim Pharmaceuticals, Inc.

Diabetes Experts Call for Early, Integrated Treatment Approach to Help Prevent Complications and Improve Patient Outcomes

Mon, 11 Mar 2010 22:00:00 GMT

Ridgefield, CT, March 11, 2010 — Results from a new online survey of more than 300 practicing endocrinologists and family medicine physicians¹ show that a large majority of physicians (83 percent)¹ indicated that using a team of specialists early in the course of type 2 diabetes (T2D) treatment can help prevent serious T2D-related complications. However, more than nine out of 10 physicians (93 percent)¹ surveyed do not believe their peers are using this team approach. The online survey was supported by Boehringer Ingelheim Pharmaceuticals, Inc. and conducted by Sermo.

Physicians surveyed identified cardiovascular disease, diabetic neuropathy (nerve pain) and diabetic nephropathy (kidney disease) as the most common complications experienced by their T2D patients.¹ Other serious complications cited include stroke, blindness and limb amputation.¹ Between 2002 and 2007, the cost of T2D-related complications to our healthcare system more than doubled from $24.6 billion to $58 billion.^2,3 The survey also measured prevalence of T2D-related complications, with more than 40 percent of physicians surveyed (44 percent) saying that over half of their T2D patients develop at least one complication.¹

“So many patients with type 2 diabetes suffer needlessly from serious and often deadly complications,” said Deborah S. Fillman, president of the American Association of Diabetes Educators and a member of the steering committee that developed the survey. “As a public health director, I have seen firsthand what an enormous burden these complications can have not only on type 2 diabetes patients themselves, but also on the healthcare system."

An integrated treatment approach means utilizing a team of specialists such as a dietitian, diabetes educator, endocrinologist, cardiologist and nephrologist to help T2D patients manage all aspects of the complex condition. While the approach has been used over the last decade in diabetes care centers across the country, its potential value to patients, in terms of increasing understanding of and preventing complications like heart attack and kidney failure, warrants further exploration.

Physicians surveyed confirmed the need for increased patient understanding of T2D-related complications. For example, despite the fact that T2D is a leading cause of kidney disease and dialysis,⁴ 40 percent of physicians surveyed do not believe the majority of their newly-diagnosed patients know that T2D can lead to kidney disease.¹

“It’s concerning that so many newly-diagnosed patients are unaware that kidney problems are a common complication of type 2 diabetes,” said Dr. Mark Williams, clinical investigator and senior staff physician, Joslin Diabetes Center and a member of the steering committee. “My patients often associate kidney damage with the need for dialysis, but they don’t realize that the damage starts early on. Many people who are diagnosed with type 2 diabetes already have some degree of kidney impairment.”

Research shows that kidney impairment can also be an independent predictor of other T2D-related complications such as heart disease,⁵ which can account for up to 50 percent of all diabetes deaths.⁶ People with T2D are more than twice as likely to have a heart attack than those who don't have the condition.⁷

Additional Survey Findings

Physicians surveyed report lack of motivation, lack of adherence to medication and inability to lose weight as the most common reasons their T2D patients are not effectively controlled.¹ Compliance with lifestyle modifications, compliance with medication and patient understanding are the top-reported obstacles to preventing complications.¹
Seven out of 10 endocrinologists polled (71 percent)¹ have a diabetes educator in their practice; only three out of 10 family physicians (32 percent) have one.¹
Half of physicians (52 percent)¹ say they monitor for all T2D-related complications equally.
Family physicians polled are more likely than endocrinologists to refer to nephrologists when mild kidney impairment is detected (32 percent vs. 12 percent); endocrinologists tend to wait until kidney function has declined to “moderate.”¹
Endocrinologists tend to be more enthusiastic than family practitioners about referring their T2D patients to healthcare specialists. Nearly four of 10 (36 percent)¹ endocrinologists surveyed consider the integrated approach to be "extremely beneficial" while one in four (25 percent)¹ family medicine practitioners say the same.

“We hope that these survey findings serve as a call to action for the type 2 diabetes treatment community,” said Deborah S. Fillman. “Now is the time to defy this type 2 diabetes epidemic and the common, and potentially preventable, complications that affect millions of patients.”

About the Steering Committee
Boehringer Ingelheim Pharmaceuticals, Inc. convened a multi-disciplinary steering committee to develop a survey and interpret its findings with the aim of educating and inspiring action among T2D patients who are at risk for serious complications. Following the completion of the survey, the committee is continuing to work closely with the diabetes care community to help patients better understand the impact of T2D-related complications and empower them to work more closely with their healthcare team to better manage all aspects of their T2D.

Steering committee members include:

Deborah S. Fillman, MS, RD, LD, certified diabetes educator, president of the American Association of Diabetes Educators (AADE)
Vivian Fonseca, MD, endocrinologist, Tulane University Medical Center
Peter A. McCullough, MD, cardiologist, William Beaumont Hospital
Mark Williams, MD, nephrologist, Joslin Diabetes Center

About the Survey
A total of 303 physicians (203 family medicine, 100 endocrinologists)¹ were polled online via Sermo in December 2009. Physicians polled treated an average of 47 T2D¹ patients per week and have been practicing for an average of 19 years.¹

About Sermo
Sermo is the largest online physician community, where over 110,000 physicians¹ collaborate to improve patient care. Through a unique set of social media tools, Sermo provides access to its community for organizations that need fast, actionable physician insights. Visit http://www.sermo.com to learn more.

About Type 2 Diabetes
There are approximately 27 million Americans⁸and 285 million⁸ people worldwide with diabetes. Every ten seconds two people develop diabetes and one person dies from diabetes-related causes around the world.⁷ Diabetes is a chronic disease that occurs when the body either does not properly produce or use the hormone, insulin.⁷ Type 2 diabetes is the most common form, accounting for more than 90 percent of all cases in the developed world.⁶

For more information, please visit http://us.boehringer-ingelheim.com and follow us on Twitter at twitter.com/boehringerus.

References

Sermo. Survey Analysis: Type 2 Diabetes Mellitus Treament. January 2010.
American Diabetes Association. Economic Costs of Diabetes in 2002. Diabetes Care, March 2003 vol. 26 no3. 917-93.
American Diabetes Association. Economic Costs of Diabetes in 2007. Diabetes Care, March 2008 vol. 31 no3. 596-615.10.
Centers for Disease Control. National Diabetes Fact Sheet-2007. Available at: http://www.cdc.gov/diabetes/pubs/pdf/ndfs_2007.pdf. 8. Accessed on: March 1, 2010.
Borch-Johnsen K et al. Urinary albumin excretion. An independent predictor of ischemic heart disease. Arterioscler Thromb Vasc Biol 19(8): 1992-1997,1999
World Health Organization. Fact Sheet No. 312: What is Diabetes? Available at: http://www.who.int/mediacentre/factsheets/fs312/3. en/. Accessed on: March 1, 2010.
International Diabetes Federation. Diabetes Atlas. 3rd ed. Brussels: International Diabetes Federation, 2006.
International Diabetes Federation. Diabetes Atlas. 4th ed. Brussels: International Diabetes Federation, 2009.

FDA approves once-daily MIRAPEX ER for the treatment of early Parkinson’s disease

Mon, 22 Feb 2010 22:00:00 GMT

Ridgefield, CT, February 22, 2010 — Boehringer Ingelheim Pharmaceuticals, Inc., today announced that the U.S. Food and Drug Administration (FDA) has approved Mirapex ER® (pramipexole dihydrochloride) extended-release tablets, a new once-daily treatment option for the signs and symptoms of early idiopathic Parkinson’s disease (PD).¹ MIRAPEX ER is not indicated in advanced PD. Parkinson’s disease is a chronic, slowly progressive and potentially debilitating neurological condition² affecting nearly one million people in the U.S., with one person newly diagnosed every nine minutes.³

“MIRAPEX ER for early Parkinson’s disease is a positive development in the treatment of this disease. This new, once-daily treatment has a more convenient dosing schedule, offering greater flexibility as someone with early Parkinson’s disease plans his or her day,” said Robert Hauser, M.D., professor of Neurology, and director, Parkinson's Disease & Movement Disorders Center at the University of South Florida College of Medicine. “In general, patients often prefer once-daily dosing to a more frequent regimen because of convenience.”

Findings from clinical studies show MIRAPEX ER to be superior to placebo and with benefits comparable to the currently available immediate-release MIRAPEX in early Parkinson’s disease.⁴ More than twelve years of real-world experience supports the use of pramipexole in the treatment of Parkinson’s disease.⁵

“We are committed to providing effective treatment options that may help ease the burden of Parkinson’s disease, and the MIRAPEX ER approval is very exciting,” said Albert Ros, executive vice president, Boehringer Ingelheim Pharmaceuticals, Inc. “The Parkinson’s community now has an important new treatment option with benefits similar to the currently available immediate-release formulation.”

Clinical Trials
The FDA approval was supported by clinical pharmacokinetic data, and by a single randomized, double-blind, placebo-controlled multicenter clinical trial. A second study evaluated an overnight switch from MIRAPEX to MIRAPEX ER.¹ The clinical trial program involved more than 400 patients with early Parkinson’s disease who were treated with varying doses of MIRAPEX ER, MIRAPEX or placebo⁴ and assessed after periods of nine weeks and 18 weeks.⁴ The first study, conducted in people with early Parkinson’s disease, compared MIRAPEX ER and MIRAPEX, each versus placebo. Patients treated with MIRAPEX ER experienced clinically significant symptom relief, as measured by mean change from baseline in Unified Parkinson’s Disease Rating Scale (UPDRS)* II+III score, compared with placebo.¹ A second study evaluated the efficacy of an overnight switch from MIRAPEX to MIRAPEX ER.¹ Eighty-five percent (87 of 104) of patients who completed the trial were successfully switched to Mirapex ER® (pramipexole dihydrochloride) extended-release tablets. Some patients required dose adjustments.¹

Early Parkinson’s disease Clinical Highlights:

Patients with early PD who were treated with MIRAPEX ER showed clinically significant improvement in symptoms after 18 weeks compared to placebo.1 In the same study, MIRAPEX-treated patients experienced similar clinically significant improvements, compared to placebo.⁴

After 18 weeks, patients treated with MIRAPEX ER experienced statistically significant improvement versus placebo in UPDRS II+III score.¹

In a nine-week study, the majority of early PD patients treated with MIRAPEX were successfully switched overnight to MIRAPEX ER.⁴

Patients treated with MIRAPEX were randomized overnight to MIRAPEX ER or to MIRAPEX. Primary efficacy endpoint was the proportion of patients successfully switched (no worsening of UPDRS II+III >15 percent from baseline and no drug-related adverse event leading to withdrawal) to MIRAPEX ER.⁴ More than 95 percent of patients completed the trial.⁶ Eighty-five percent (87 of 104 patients) were successfully switched (some patients required dose adjustments) to the once-daily formulation.¹ These data support a 1:1 switch from MIRAPEX to MIRAPEX ER for most patients.⁴

In both of the studies, the safety and tolerability profile of MIRAPEX ER in patients with early PD was similar to that of MIRAPEX when each was compared with placebo.⁴

About Parkinson’s disease
Parkinson’s disease is a progressive neurological disorder² that affects nearly one million people in the U.S.³ It is the second most common chronic neurological disorder in older adults after Alzheimer’s.⁷ Every nine minutes someone is diagnosed with Parkinson’s disease.³ Symptoms include tremor, muscle rigidity, slowed motion, shuffling gait, and a loss of facial expression.⁸ The symptoms vary from individual to individual, but become more severe over time.^8,7 Although promising research is being conducted, there is currently no cure for Parkinson’s disease.⁹

About Mirapex® (pramipexole dihydrochloride) tablets and Mirapex ER® (pramipexole dihydrochloride) extended-release tablets
MIRAPEX is indicated in the U.S. for the treatment of the signs and symptoms of idiopathic Parkinson’s disease in a three times daily immediate-release formulation.¹⁰ MIRAPEX ER is now approved in a once-daily, extended-release formulation for early Parkinson’s disease.¹ MIRAPEX is supported by more than twelve years of real-world experience in the treatment of Parkinson’s disease, with more than 16 million prescriptions written in the U.S. since its launch in 1997.^11,5

Mirapex ER® (pramipexole dihydrochloride) extended-release tablets are not indicated for advanced Parkinson’s disease or for the treatment of restless legs syndrome (RLS).

Important Safety Information:
MIRAPEX ER and MIRAPEX may cause you to fall asleep while you are doing daily activities such as driving, talking with other people, or eating. Talk to your doctor if you drink alcohol or take other medications that make you drowsy, as these can increase the chance that MIRAPEX ER or MIRAPEX will make you feel sleepy or fall asleep when you should be awake. When taking MIRAPEX ER or MIRAPEX, hallucinations (unreal visions, sounds or sensations) may occur and you may sometimes feel dizzy, nauseated, faint or sweaty when you sit up or stand quickly.

In a clinical trial for early Parkinson’s disease (PD), the most commonly reported side effects of MIRAPEX ER that were more frequent than with placebo are sleepiness, nausea and vomiting, constipation, dizziness, fatigue, hallucinations, dry mouth, muscle spasms, and edema (swelling of the feet and ankles).

In clinical trials for early PD, the most commonly reported side effects of MIRAPEX that were more frequent than with placebo are nausea, dizziness, sleepiness, difficulty falling asleep, weakness, and constipation.

Some patients taking certain medicines to treat PD, including MIRAPEX ER and MIRAPEX, have reported problems such as gambling, compulsive eating, compulsive buying and increased sex drive. If you or your family members notice that you are developing unusual urges or behaviors, talk to your doctor.

For full MIRAPEX ER or MIRAPEX prescribing information, please contact Boehringer Ingelheim’s Drug Information Unit at 1-800-542-6257.

For more information, please visit http://us.boehringer-ingelheim.com.

References

Mirapex ER® (pramipexole dihydrochloride) extended-release tablets Prescribing Information (Rev. February 2010).
Parkinson’s Disease: Hope Through Research. National Institute of Neurological Disorders and Stroke. Parkinson’s Disease. http://www.ninds.nih.gov/disorders/parkinsons_disease/detail_parkinsons_disease.htm#58003159 [Last accessed 2/18/10].
Obeso JA, Olanow CW, Nutt JG. Levodopa motor complications in Parkinson’s disease. Trends Neurosci. 2000; 23: S2-S7.
Boehringer Ingelheim Pharmaceuticals, Inc. 2.5 Clinical Overview (pramipexole dihydrochloride extended release tablets). Submitted to FDA October 3, 2008.
Mirapex (PD) FDA Approval Letter (7/1/1997).
Rascol O et al. Overnight switching from immediate- to extended-release pramipexole in early Parkinson’s disease. Abstract P06.152 presented on 29 April 2009 at AAN 61st Annual Meeting, Seattle, USA, 30 April – 02 May 2009.
Parkinson Primer: Overview of Parkinson Disease. National Parkinson Foundation. http://www.parkinson.org/NETCOMMUNITY/Page.aspx?pid=226&srcid=200 [Last accessed 2/18/10].
Kittle G. Parkinson Disease: A Basic Understanding. Parkinson Disease: What You and Your Family Should Know. 2006; 3-10.
National Parkinson Foundation. Your Guide to Parkinson’s disease. 2005.
Mirapex® (pramipexole dihydrochloride) Prescribing Information (Rev. April 2009).
IMS Data on file, Boehringer Ingelheim Pharmaceuticals, Inc.

Celebrities ‘Tweet’ to Drive COPD Awareness and Action

Thu, 18 Feb 2010 22:00:00 GMT

- Patty Loveless Wins the DRIVE4COPD “Race for the Missing Millions” by Screening Nearly 6,000 People during Celebrity Kickoff -

Ridgefield, CT, February 18, 2010 —Hollywood, sports and music stars brought the public along for the ride as they raced 6,000 miles in four days to find the millions of people who may be at risk for Chronic Obstructive Pulmonary Disease (COPD), which kills one person every four minutes. Through Twitter, Facebook, Flickr and YouTube, tens of thousands of people followed the celebrities as they traveled to 14 cities to screen thousands of people for this relatively unknown top cause of death.

The result: more than 27,000 people completed the validated five-question screener available at DRIVE4COPD.COM to see if they were at risk for COPD. The screener helps people talk to their doctor about their breathing problems, which is important because most people are not diagnosed with COPD until they have already lost half of their lung function. The goal is to drive 1 million people to get screened in the first year of the campaign.

“We were thrilled with this level of engagement since COPD has been largely ignored even though it is the nation’s fourth leading cause of death,” said Chris Barrett, Senior Vice President at Boehringer Ingelheim Pharmaceuticals, Inc., the founding sponsor of the campaign. “And this is just the beginning, as the campaign will continue to build with many more activities and partnerships planned this year.”

For Grammy Award-winning country music star Patty Loveless, Tweets from her fans and the buzz about her inspiring new single Drive bolstered the number of screeners she collected to win the first leg of the DRIVE4COPD “Race for the Missing Millions.” Loveless beat out her fellow DRIVE4COPD celebrity ambassadors – Emmy-nominated actor Jim Belushi, former Pro Football great Michael Strahan, and Olympic Gold Medalist Bruce Jenner – who participated in the race in memory of relatives with COPD.

“I met hundreds of people along my route and it seems like nearly everyone knows someone with COPD,” said Loveless, who lent her voice to the cause and traveled from Daytona, FL to Chicago. “It meant a lot to me to hear their stories and share my memories of my sister who struggled for years with emphysema, a form of COPD.”

Go Daddy and NASCAR Nationwide Series™ driver Danica Patrick, who was the Grand Marshall of the “Race for the Missing Millions,” had a strong showing with more than 9,000 screeners. Now, following the celebrity four-day race, the campaign continues with local COPD screening events at NASCAR races, major sporting events and country music concerts throughout the year. The DRIVE4COPD celebrity ambassadors will also be spreading their message through public service announcements and briefings on Capitol Hill.

It is estimated that half of the 24 million people in the United States who may have COPD remain undiagnosed. The serious, progressive disease – which includes chronic bronchitis, emphysema, or both – robs people of their ability to breathe and kills more Americans each year than breast cancer and diabetes combined.

“People often ignore symptoms, such as shortness of breath, until they have trouble doing everyday activities,” said Brian Carlin, MD, Pulmonary and Critical Care Medicine, Drexel University School of Medicine. “This campaign helps people understand if they are at risk so they can get on the road to breathing better sooner.”

The DRIVE4COPD campaign encourages the public to learn about COPD, recognize its early symptoms, complete a five-question screener at DRIVE4COPD.COM to find out if they may be at risk, and then talk to their doctor about their results. In addition to the validated risk screener, the DRIVE4COPD Web site provides information on the disease and on the importance of taking active steps to manage it with a doctor. It also includes many social media tools to get the word out.

DRIVE4COPD Screener
Given the underdiagnosis of COPD, there was a need for a reliable, self-scored questionnaire to identify individuals at risk for COPD. The development of this questionnaire began with a list of items identified for inclusion by a clinician working group of 10 pulmonologists and primary care physicians. A national survey of nearly 700 patients at 12 practitioner sites found five items that positively predicted airflow obstruction: breathlessness, productive cough, activity limitation, smoking history and age. These five items became the COPD Population Screener™ found at DRIVE4COPD.COM. The study validating this screener was published in April 2008 (Martinez, F. J., Raczek, A. E., Seifer, F. D., Conoscenti, C. S., Curtice, T. G. & D'Eletto, T., et al. Development and Initial Validation of a Self-Scored COPD Population Screener Questionnaire (COPD-PS). COPD: Journal of Chronic Obstructive Pulmonary Disease, 5:2, 85-95).

About COPD
Both types of Chronic Obstructive Pulmonary Disease (COPD) – chronic bronchitis and emphysema – make it harder to breathe because less air is able to flow in and out of the lungs.

As many as 24 million Americans have COPD – even those who haven’t smoked in years – and half of them are not diagnosed. COPD is the fourth leading cause of death in the United States. It kills one person every 4 minutes and more people each year than breast cancer and diabetes combined.

COPD can be managed to help people live and breathe easier. Early diagnosis of COPD is critical, as lung damage is not reversible but is treatable. Proper management of COPD is important to help patients breathe better, prevent complications and exacerbations, and improve quality of life. Lifestyle changes like staying active and quitting smoking can help improve symptoms. Yet even when people are diagnosed with COPD, only half of them are prescribed treatment to help them breathe better.

NASCAR
The National Association for Stock Car Auto Racing, Inc. (NASCAR) is the sanctioning body for one of North America's premier sports. NASCAR races are broadcast in more than 150 countries and 20 languages. NASCAR fans are the most brand loyal in all of sports, and as a result more Fortune 500 companies participate in NASCAR than any other sport.

For more information, please visit http://us.boehringer-ingelheim.com and follow us on Twitter at twitter.com/boehringerUS.

NASCAR® is a registered trademark of the National Association for Stock Car Auto Racing, Inc.

New Research Shows Emotional Impact of Low Sexual Desire and Associated Distress on Women

Thu, 18 Feb 2010 22:00:00 GMT

- Patient Registry Formed to Track Clinical Course of Hypoactive Sexual Desire Disorder -

Ridgefield, CT, February 18, 2010 — New findings from a European study show that women with low sexual desire and associated distress experience personal and emotional distress related to the sexual issue. The findings, presented today at the International Society for the Study of Women’s Sexual Health (ISSWSH) 2010 Annual Meeting in St. Petersburg, Fla., are based on a survey of 5,098 women with low sexual desire and associated distress. In the study (DESIRE®), many women reported experiencing negative emotions, such as dissatisfaction with their sex life, guilt about sexual difficulties and distress about their sex life, frequently or always during the previous three months.

The DESIRE® (Desire and its Effects on female Sexuality Including Relationships) study identified 7,542 women with low sexual desire and associated distress. Among these women, 5,098 participated and were surveyed on a wide range of attitudes and behaviors relating to their experience of low sexual desire. The reports of their frequency and level of sexual desire over the last 12 months were significantly correlated with reports of their level of distress about their low sexual desire and with each of these negative emotional responses.

The DESIRE study methodology consisted of 65,129 women, ages 18-88 years, from France, Germany, Italy, Spain and the UK, participating in a demographically representative research panel. These women completed an initial screening comprised of the first four questions of the Decreased Sexual Desire Screener® (DSDS®). The DSDS is a five-question diagnostic tool that assists non-expert clinicians in the clinical diagnosis of generalized, acquired Hypoactive Sexual Desire Disorder (HSDD), with more than 85 percent accuracy. In total, 7,542 women answered “yes” to all four questions and did not attribute their desire problem to partner sexual issues or physical trauma and 5,098 women further chose to participate in the in-depth survey.

About the HSDD Patient Registry
To understand the natural course of HSDD in women, the New England Research Institutes in Watertown, Mass., is conducting the first-ever registry in female sexual health. The HSDD Registry for Women is a prospective, multicenter, observational study, which will provide data on the natural history and long-term consequences of HSDD.

“The HSDD Registry for Women is the first sexual medicine registry of its kind to investigate the history and clinical course of generalized, acquired Hypoactive Sexual Desire Disorder in women,” said Ray Rosen, Ph.D., Chief Scientist of the New England Research Institutes. “With its in-depth analysis of medical co-morbidities, lifestyle factors and long-term outcomes, we expect the HSDD Registry to address a number of knowledge gaps surrounding HSDD in women.”

Nearly one in 10 women report low sexual desire with associated distress, which may be HSDD, an often under-diagnosed condition that is defined as a decrease or lack of sexual desire that causes distress for the patient, may put a strain on relationships with partners, and is not due to the effects of a substance, including medications, or another medical condition.

“Many of the women I see with HSDD experience a high level of guilt and feelings of confusion,” said Sheryl Kingsberg, Ph.D., President of ISSWSH, Chief of Behavioral Medicine at University Hospitals Case Medical Center, and professor in reproductive biology at Case Western Reserve University in Cleveland. “They also complain about the distance they feel between themselves and their partner. The emotional impact of HSDD is significant, so I am excited by the growing body of research being presented this year as it provides an in-depth look at this under-recognized but distressing condition.”

The study and patient registry are supported by unrestricted grants through Boehringer Ingelheim Pharmaceuticals, Inc.

About the DSDS
The DSDS diagnostic tool consists of five Yes or No questions:

In the past, was your level of sexual desire/interest good and satisfying to you?
Has there been a decrease in your level of sexual desire/interest?
Are you bothered by your decreased level of sexual desire/interest?
Would you like your level of sexual desire/interest to increase?

In a fifth Yes or No question, women are asked to note any factors from the following list they feel may be contributing to a loss of sexual desire or interest.

Medications, drugs or alcohol you are currently taking
Pregnancy, recent childbirth, menopausal symptoms
Other sexual issues you may be having (pain, decreased arousal or orgasm)
Your partner’s sexual problems
Dissatisfaction with your relationship or partner
Stress or fatigue

About Hypoactive Sexual Desire Disorder
Low sexual desire with associated distress is the most commonly reported female sexual complaint. Approximately one in 10 women report low sexual desire with associated distress, which may be HSDD. HSDD is a form of female sexual dysfunction (FSD) and has been recognized as a medical condition for more than 30 years. As defined by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR), HSDD is the persistent lack (or absence) of sexual fantasies or desire for any form of sexual activity causing marked distress or interpersonal difficulty and not better accounted for by another disorder (except another sexual dysfunction), direct physiological effects of a substance (including medications), or a general medical or psychiatric condition. Generalized, acquired HSDD is not limited to certain types of stimulation, situations or partners, and develops only after a period of normal functioning. There has been an unmet need for many women and there is no FDA-approved treatment for HSDD. It can affect women of all ages and at any stage of life.

For more information, please visit http://us.boehringer-ingelheim.com.

DRIVE4COPD Sheds Light on the Nation's 4th Leading Killer Through Unprecedented Public Health Initiative

Wed, 3 Feb 2010 22:00:00 GMT

- Hollywood, Sports and Music Stars Drive 6,000 Miles Cross Country to Identify the Millions of People with COPD Who May Not Know They Have It -

Ridgefield, CT, February 3, 2010 —A powerful group of entertainment, sports and healthcare organizations and celebrities have joined forces to screen millions of people who may be at risk for Chronic Obstructive Pulmonary Disease (COPD), the nation’s fourth leading cause of death. The American Lung Association, Boehringer Ingelheim Pharmaceuticals, Inc., COPD Foundation and NASCAR® today kicked off DRIVE4COPD, a multi-year public health initiative aiming to reach millions of Americans about the need for early detection of COPD.

An estimated half of the 24 million people in the United States who may have COPD remain undiagnosed. The serious, progressive disease – which includes chronic bronchitis, emphysema, or both – robs people of their ability to breathe and kills more Americans each year than breast cancer and diabetes combined.

“Most people believe their symptoms, such as shortness of breath, are just normal signs of aging so they are not diagnosed until they have already lost half of their lung function,” said Charles D. Connor, American Lung Association president and CEO. “It is important to recognize symptoms and see a doctor early before the lungs become severely damaged. We believe DRIVE4COPD will encourage people to take action when it comes to this progressive disease.”

That’s why NASCAR Nationwide Series™ driver, Danica Patrick, is joining with Emmy-nominated actor Jim Belushi, Olympic Gold Medalist Bruce Jenner, Grammy Award-winning country music star Patty Loveless and former Pro Football great Michael Strahan in the DRIVE4COPD campaign, a nationwide search for the millions of people who don’t realize they may be at risk for COPD.

“I remember how my grandma struggled to breathe and how it limited her life,” said Patrick, whose grandmother suffered from emphysema, one of the two forms of COPD. “That’s why our goal is to get at least 1 million people to take a five-question screener to find out if they may be at risk for COPD and talk to their doctor. Because the sooner you act, the sooner you can get on the road to breathing better.”

Race for the Missing Millions with COPD
Patrick is readying the members of the DRIVE4COPD Race Team -- who all have close family members touched by COPD -- to drive 6,000 miles across the country in four days in the “Race for the Missing Millions.” They will be calling on people to complete a five-question screener to see if they are at risk for this common disease. The screener can be found at DRIVE4COPD.COM.

The race starts on February 13, 2010 after Loveless debuts the song she composed for the campaign in front of packed stands at the historic Daytona International Speedway, a day prior to the famed DAYTONA 500®. The song, in memory of Loveless’ sister who died at a young age from emphysema, hopes to inspire others with COPD to take action to continue to live their life.

Following her performance, Loveless joins her fellow DRIVE4COPD Race Team members on the starting line of the prestigious NASCAR Nationwide Series™ season opener to drive around the track prior to Patrick taking to the track herself to race for the DRIVE4COPD 300 checkered flag. The celebrity drivers take off from this commemorative start on four routes across the country making “Pit Stops” in 14 cities to screen as many Americans as possible to see if they may be at risk for COPD. A map of the “Race for the Missing Millions” routes and event locations is at DRIVE4COPD.COM.

“This is an important cause for NASCAR and we’re committed to helping our fans and millions of Americans who have COPD by increasing public understanding of the disease,” said Steve Phelps, senior vice president and chief marketing officer, NASCAR. “We are thrilled that this campaign has become the official health initiative of NASCAR, making its first ‘Pit Stop’ during the popular Daytona weekend and coming to many other races this season.”

Following the celebrity four-day kick off, the race continues with local COPD screening events at NASCAR races, major sporting events and country music concerts. The DRIVE4COPD celebrity ambassadors will continue spreading their message through public service announcements and briefings on Capitol Hill throughout the year.

“Everyone in America knows someone with COPD and unfortunately half of them are symptomatic and don’t know they have it,” said John Walsh, president of the COPD Foundation and an individual living with COPD. “COPD affects more women than men. Although smoking’s a major risk factor, it’s not the only one. Environmental exposures and genetics are also involved. That’s why it’s important to spread awareness about COPD so individuals affected feel empowered and take charge.”

The campaign encourages the public to learn about COPD, recognize its early symptoms and complete a five-question screener at DRIVE4COPD.COM to find out if they may be at risk. Those at risk include people 35 years of age or older or those who have smoked more than 100 cigarettes in a lifetime. The DRIVE4COPD Web site provides information on the disease and on the importance of taking active steps to manage it with a doctor. Those completing the five-question screener also have a chance to win an Ultimate NASCAR® Weekend.*

“As a leader in respiratory health, and a company committed to improving the lives of patients and their families, we are proud to be the founding sponsor for this important awareness initiative, and to be collaborating with ambassadors and organizations who share our goal of shining a much-needed spotlight on COPD,” said J. Martin Carroll, president and CEO, Boehringer Ingelheim USA. “Someone dies from COPD every four minutes, yet most Americans still don’t know what COPD is. We are committed to helping people learn about their risk and recognize early symptoms, and encouraging them to take action today so they can breathe better tomorrow.”

About COPD
Both types of Chronic Obstructive Pulmonary Disease (COPD) – chronic bronchitis and emphysema – make it harder to breathe because less air is able to flow in and out of the lungs.

As many as 24 million Americans have COPD – even those who haven’t smoked in years – and half of them remain undiagnosed. COPD is the fourth leading cause of death in the United States. It kills one person every 4 minutes and more people each year than breast cancer and diabetes combined.

For more information, please visit http://us.boehringer-ingelheim.com and follow us on Twitter at twitter.com/boehringerUS.

Boehringer Ingelheim Cares Foundation Assists in Haiti Disaster Relief

Thu, 14 Jan 2010 22:00:00 GMT

Ridgefield, CT, January 14, 2010 - On Tuesday, January 12, a 7.3 magnitude earthquake hit 10 miles southwest of Port-au-Prince, followed by at least five powerful aftershocks. The massive destruction left in the wake of the quake is devastating and our hearts reach out to all those families affected.

The Boehringer Ingelheim Cares Foundation is working to respond to requests for assistance for Haiti. In disasters such as this, the Boehringer Ingelheim Cares Foundation Product Donation Program provides medical donations through our established donation partners, AmeriCares, Catholic Medical Mission Board, Direct Relief International and MAP International.

We have chosen to partner with each of these organizations because they are experts in providing disaster response, and many already have response teams assessing and responding to this catastrophe. We encourage you to visit these sites for additional information on how you can help the individuals and families affected by this terrible tragedy.

In addition to our medical donations, our partners are currently assessing the actual needs on the ground so that we can explore more ways in which our employees and our company can contribute to the disaster relief effort in Haiti.

AmeriCares:
http://www.americares.org/?linkid=donationbreadcrumb/

Catholic Medical Mission Board:
http://www.cmmb.org/

Direct Relief International:
http://www.directrelief.org/EmergencyResponse/2010/EarthquakeHaiti.aspx

MAP International:
http://www.map.org