The
off-label use of dabigatran (Pradaxa) in patients with mechanical heart valves
may be problematic, according to two case reports in the Journal of the American College of
Cardiology.
In both
instances, the patients had been switched from warfarin to dabigatran, which is
approved for reducing stroke risk in nonvalvular atrial fibrillation.
The
patients, two women in their 50s, became symptomatic within a month of
switching to dabigatran. One woman was on warfarin for 8 years after receiving
an aortic valve replacement. The other woman was on warfarin for about 5 years
for a prosthetic mitral valve, reported Joel Price, MD, MPH, and colleagues
from the University of Ottawa Heart Institute in Ontario, in a research
correspondence.
The
patients were compliant with warfarin and with dabigatran, and neither
experienced valve thrombus or bleeding while on warfarin.
"I
would not use factor IIa or Xa inhibitors in place of warfarin in patients with
a mechanical valve requiring anticoagulation except in the context of a
clinical trial or for compassionate use indications," Gordon Tomaselli,
MD, director of cardiology at Johns Hopkins School of Medicine in Baltimore,
told MedPage Today.
Boehringer
Ingelheim, dabigatran's manufacturer, last year launched the phase II RE-ALIGN
trial, which is testing three doses of the drug in patients with mechanical
valves.
POSTED BY: Steven
Almany M.D.
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