BIPI to launch dabigatran etexilate Phase II trial in patients with mechanical heart valves

Boehringer Ingelheim Pharmaceuticals, Inc. (BIPI) today announced plans to launch RE-ALIGN™, a global, Phase II trial evaluating the safety and pharmacokinetics of dabigatran etexilate in 400 patients who have mechanical heart valves. The 12-week study will compare three doses of dabigatran etexilate (150mg bid, 220mg bid and 300mg bid) to warfarin in patients with both aortic valve replacements and mitral valve replacements. A RE-ALIGN extension study will evaluate the ongoing safety of dabigatran etexilate in this patient population for up to 84 months.

Mechanical heart valves are used to treat heart valve disease, which occurs when one or more valves in the heart does not function properly. An estimated 2.5 percent of the American population has heart valve disease. Approximately 100,000 patients undergo heart valve replacement in the U.S. each year, 55 percent of which are mechanical heart valves. Patients with mechanical heart valves require lifelong anticoagulation to help prevent blood clots from forming on or around the valve. A meta-analysis of 46 studies involving patients with mechanical heart valves found the annual incidence of thromboembolism for those who are untreated to be 8.6 percent.

"Boehringer Ingelheim is committed to ongoing research that will expand our understanding of dabigatran etexilate as a treatment option for patients with a variety of cardiovascular and thromboembolic conditions," said John Smith, MD, PhD, senior vice president for clinical development and medical affairs, Boehringer Ingelheim Pharmaceuticals, Inc. "We are proud to announce the launch of RE-ALIGN and plans for a RE-ALIGN extension study, to assess dabigatran etexilate as a potential treatment option to reduce stroke risk in patients with mechanical heart valves."

Dabigatran etexilate was approved by the FDA in October 2010 as the first oral anticoagulant in more than 50 years to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation (NVAF) and is sold under the brand name Pradaxa®. In the first eight months after approval, nearly 300,000 patients in the U.S. were prescribed PRADAXA.  

"PRADAXA has almost a full year of clinical use for the reduction of stroke risk in patients with non-valvular atrial fibrillation," said Chris Barrett, senior vice president, marketing, Boehringer Ingelheim Pharmaceuticals, Inc. "We continue to see a steady growth in the number of patients treated with PRADAXA and are proud of the widespread formulary coverage that has been achieved, providing access to 90 percent of covered lives in the U.S."

Findings from the Phase III RE-LY® trial showed that PRADAXA 150mg taken twice daily significantly reduced stroke and systemic embolism by 35 percent beyond the reduction achieved with warfarin (dosed to international normalized ratio (INR) 2.0 to 3.0, mean time in therapeutic range = 64.4 percent) in patients with NVAF. Effects of PRADAXA were more apparent in patients with lower levels of INR control.  Dabigatran is recommended in an update to atrial fibrillation treatment guidelines.