TOKYO and INDIANAPOLIS Results of a new study conducted by Eli Lilly and Daiichi Sankyo for their experimental blood thinner prasugrel showed some positives and negatives when compared to Bristol-Myers Squibb and Sanofi-Aventis’ blood thinner Plavix.
While the drug lowers the risk of cardiovascular death, it does increase the risk of major bleeding in patients when compared to Plavix.
In a study of 13,000 patients taking prasugrel had a 19 percent lower risk of cardiovascular death, nonfatal heart attacks and nonfatal strokes compared to Plavix. But, 2.4 percent of patients taking the drug experienced major bleeding compared to only 1.8 percent for those taking Plavix. Also, life-threatening bleeding occurred in 1.4 percent of patients taking prasugrel compared to 0.9 percent of Plavix patients.
The companies said they had identified three major risk factors for significant bleeding while on prasugrel: patients who were older than 75 years, weighed less than 132 pounds or had a history of transient ischemic attack or stroke. Patients without those risk factors had an equal risk of major bleeding whether they received prasugrel or Plavix.
The companies intend to submit the new drug application for prasugrel to the Food and Drug Administration by the end of the year.