RIDGEFIELD, Conn., Aug. 26, 2011 /PRNewswire/ — 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.(1) 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.(1) A RE-ALIGN extension study will
evaluate the ongoing safety of dabigatran etexilate in this patient
population for up to 84 months.(1)
Mechanical heart valves are used to treat heart valve disease,
which occurs when one or more valves in the heart does not function
properly.(2) An estimated 2.5 percent of the American population
has heart valve disease.(3) Approximately 100,000 patients undergo
heart valve replacement in the U.S. each year,(4) 55 percent of
which are mechanical heart valves.(5) Patients with mechanical
heart valves require lifelong anticoagulation to help prevent blood
clots from forming on or around the valve.(6) 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.(7)
“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
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