Boehringer Ingelheim announced plans to launch RE-ALIGN, a global, phase II trial evaluating the safety and pharmacokinetics of dabigatran etexilate (Pradaxa) 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.
According to the American Heart Association, an estimated 2.5% of the American population has heart valve disease and approximately 100,000 patients undergo heart valve replacement in the USA each year. Butany J et al estimates that 55% of the heart valves replaced are mechanical heart valves. A report from the American College of Cardiology/American Heart Association suggests that patients with mechanical heart valves require lifelong anticoagulation to help prevent blood clots from forming on or around the valve.
“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, senior vice president for clinical development and medical affairs, Boehringer Ingelheim. “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.
Findings from the phase III RE-LY trial showed that Pradaxa 150mg taken twice daily significantly reduced stroke and systemic embolism by 35% beyond the reduction achieved with warfarin (dosed to international normalised ratio (INR) 2.0 to 3.0, mean time in therapeutic range = 64.4%) in patients with non-valvular atrial fibrillation.
