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.