Boehringer Ingelheim Pharmaceuticals, Inc. provides human prescription medicines. It offers pharmaceutical products for the treatment of lung health, cardiovascular diseases, men's prostate health, and anti-viral therapy. The company also provides angiotensin II receptor blocker Micardis tablets for the reduction of the risk of myocardial infarction, stroke, or death from cardiovascular causes in patients who are unable to take angiotensin-converting enzyme inhibitors; and COMBIVENT RESPIMAT (ipratropium bromide and albuterol), an inhaler for patients with chronic obstructive pulmonary disease. In addition, its products include Flibanserin, a compound for the treatment of hypoactive sexual d...
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Boehringer Ingelheim Pharmaceuticals, Inc. Announces Results from the RE-COVER II Study of Dabigatran Etexilate Mesylate Met Primary Endpoint for Six-Month Treatment of Deep Vein Thrombosis (DVT) And/Or Pulmonary Embolism (PE)
Dec 17 13
Boehringer Ingelheim Pharmaceuticals, Inc. announced results from the RE-COVER(TM) II study evaluating dabigatran compared to warfarin in patients diagnosed with acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE). In this Phase III study, published online in the American Heart Association's journal Circulation, dabigatran met the primary endpoint of non-inferiority to warfarin for recurrent, symptomatic, objectively-confirmed DVT and/or PE and related deaths during six months of treatment. DVT and PE are collectively referred to as venous thromboembolism (VTE), which is the third most common cardiovascular disorder after coronary artery disease and stroke. A DVT occurs when a blood clot develops in a deep vein, usually in the leg or pelvis, and either partially or totally blocks the flow of blood through the vein. A PE occurs when a DVT, or part of it, breaks off and travels through the bloodstream to the lungs, blocking a vessel. This is considered a life-threatening condition. RE-COVER II also showed that dabigatran was associated with a 31% reduction in the risk of major bleeding (15 dabigatran patients vs. 22 warfarin patients), which did not reach statistical significance. Additionally, the study demonstrated significantly less overall bleeding (33% reduced risk; 200 dabigatran vs. 285 warfarin patients) and major or clinically relevant non-major bleeding (38% reduced risk; 64 dabigatran vs. 102 warfarin patients). RE-COVER II was a randomized, double-blind, double-dummy study in 2,589 patients with acute symptomatic DVT and/or PE recruited at 208 study sites in 31 countries. The trial was designed to determine if dabigatran 150 mg twice daily is non-inferior to warfarin for the primary endpoint of preventing a recurrence of DVT and/or PE and related deaths, and to compare the safety of the two drug regimens during six months of treatment. In the trial, patients were treated with either dabigatran or warfarin after initial parenteral anticoagulation therapy (approximately 9 to 10 days). Patients in the warfarin group had their doses adjusted to maintain an International Normalized Ratio (INR) of 2.0-3.0. The efficacy analysis included 2,568 patients randomly assigned to the treatment groups. All patients analyzed received at least one dose of the study drug (1,279 in the dabigatran group and 1,289 in the warfarin group).* The analysis showed that dabigatran was non-inferior to warfarin for the prevention of recurrent or fatal DVT and/or PE (P<0.001 for both hazard ratios and difference in absolute risk criteria). Specifically, recurrent nonfatal or fatal DVT and/or PE was confirmed after central adjudication in 30 patients in the dabigatran group (2.3%) and in 28 patients (2.2%) in the warfarin group (hazard ratio, 1.08; 95% CI, 0.64 to 1.80). The safety analysis included 2,568 patients and was performed according to the treatment received (1,280 in the dabigatran group and 1,288 in the warfarin group). The safety findings were: Major bleeding occurred in 1.2% (15) of dabigatran patients and 1.7% (22) of warfarin patients (HR 0.69, 95% CI 0.36 to 1.32). Overall (any) bleeding occurred in significantly fewer patients in the dabigatran group compared to the warfarin group: 15.6% (200) vs. 22.1% (285), respectively (HR 0.67, 95% CI, 0.56 to 0.81). Major or clinically relevant non-major bleeding also occurred in significantly fewer dabigatran than warfarin patients: 5.0% (64) vs.7.9% (102), respectively (HR 0.62, 95% CI, 0.45 to 0.84). The overall rate of deaths and adverse events were similar in both groups, with the exception of dyspepsia, which was more common in the dabigatran group (1.0%) than in the warfarin group (0.2%). The incidence of acute coronary syndrome (ACS) was numerically higher with dabigatran than with warfarin (absolute risk increase of 0.1%). The combined studies randomized 5,107 patients who were all initially treated with parenteral anticoagulation therapy followed by warfarin or dabigatran. The hazard ratio for recurrent DVT and/or PE or related death for dabigatran compared to warfarin was 1.09 (95% CI, 0.76 to 1.57). The pooled analysis also showed lower rates of bleeding with dabigatran. The hazard ratio for major bleeding, with dabigatran compared to warfarin, was 0.73 (95% CI, 0.48 to 1.11); for any bleeding, 0.70 (95% CI, 0.61 to 0.79); and for major or clinically relevant non-major bleeding, 0.62 (95% CI, 0.50 to 0.76). Although RE-COVER and RE-COVER II individually showed a non-significant reduction in major bleeding with dabigatran, the reduction was statistically significant in the pooled analysis during the period following discontinuation of parenteral anticoagulation (i.e., during the double-dummy period): HR 0.60, 95% CI, 0.36 to 0.99. ACS occurred more with dabigatran (9 patients, 0.4%) than with warfarin (5 patients, 0.2%). Dabigatran is currently marketed as Pradaxa(R) (dabigatran etexilate mesylate) in the United States to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation; dabigatran is currently not approved by the FDA to treat DVT and/or PE.
Apollo Medical Holdings, Inc. and Boehringer Ingelheim Pharmaceuticals, Inc. to Collaborate On Care of ApolloMed Accountable Care Organization (ACO) Patients with COPD
Dec 11 13
Apollo Medical Holdings, Inc. and Boehringer Ingelheim Pharmaceuticals, Inc. announced a partnership dedicated to managing the care of ApolloMed ACO patients with chronic obstructive pulmonary disease (COPD). Boehringer Ingelheim has a vast array of provider and patient resources from their 'Strategies For Chronic Care' and 'InStep' programs, as well as the provision of provider education around the burden of illness and COPD disease management. More than 12.1 million people 18 years of age and older in the United States have been diagnosed with COPD. However, pulmonary function tests show that more than 26 million people may have the disease. According to the National Institutes of Health, chronic lower respiratory diseases, which include COPD, emphysema and asthma. This includes $29.5 billion in direct health care expenditures and $20.4 billion in indirect costs. More than 500 physicians have signed up with ApolloMed ACO, which was approved by CMS in July, 2012 to participate in the Medicare Shared Savings Program. ApolloMed ACO has initiated a high-risk program that is targeting chronic conditions, including COPD, and is excited to partner with Boehringer Ingelheim. Boehringer Ingelheim has a tradition of core competency in COPD and has developed unique resources for identifying and managing COPD patients in the outpatient and inpatient settings. In 2010, there were 822,500 hospital discharges with a diagnosis of COPD among adults age 40 years and older. Also, an additional 3.8 million hospital stays included COPD as a secondary or complicating condition during an admission for some other medical problem. Thus, nearly one out of every five patients 40 years or older in United States hospitals has a diagnosis of COPD. Hospitalization rates for acute exacerbation of COPD were highest among patients 75-84 years of age. COPD is also main cause of readmissions to the hospital. The 30-day readmission rate among patients hospitalized for COPD is 22.6%.
Boehringer Ingelheim Plans to Initiate Two New Global Clinical Trials of PRADAXA(R)
Nov 19 13
Boehringer Ingelheim Pharmaceuticals Inc. announced that it plans to initiate two new global clinical trials of PRADAXA. One of the new trials, RE-DUAL PCI(TM) ('Randomized Evaluation of Dual Therapy with Dabigatran vs. Triple Therapy Strategy with Warfarin in Patients with NVAF that have undergone PCI with Stenting'), is designed to evaluate the efficacy and safety of PRADAXA in patients with non-valvular atrial fibrillation (NVAF) who have undergone percutaneous coronary intervention (PCI), also known as angioplasty, with stent placement. The second of the new trials, RE-SPECT ESUS(TM) ('Randomized Evaluation in Secondary stroke Prevention Comparing the Thrombin inhibitor dabigatran etexilate versus ASA in Embolic Stroke of Undetermined Source'), is designed to evaluate the efficacy and safety of PRADAXA as a secondary stroke prevention therapy in patients who have suffered an embolic stroke of undetermined source (ESUS). Embolic strokes occur when a blood clot forms somewhere in the body and travels through the bloodstream to the brain. Both trials would become part of the extensive RE-VOLUTION clinical trial program for PRADAXA, which includes 10 completed phase III clinical trials involving approximately 40,000 patients in more than 44 countries globally, and are planning to begin enrollment in 2014 and 2015, respectively. RE-DUAL PCI is planned to be run cooperatively with Harvard Clinical Research Institute (HCRI) and led by Christopher Cannon, M.D., cardiologist at Brigham and Women's Hospital in Boston and Professor of Medicine at Harvard Medical School. RE-SPECT ESUS is planned to be run by Professor Hans-Christoph Diener, Professor of Neurology and Chairman of the Department of Neurology, University of Essen, Germany. The trial plans to include approximately 6,000 patients who had an ESUS within three months prior to enrollment.