Prasugrel Found to Reduce Death Risk But Increase Major Bleeding

Eli Lilly and Daiichi Sankyo have released study results showing their experimental blood-thinning drug prasugrel lowers risk of cardiovascular death but increases the risk of major bleeding compared with Plavix.

Patients taking prasugrel had a 19 percent lower risk of cardiovascular death, nonfatal heart attacks and nonfatal strokes compared with those taking Bristol-Myers Squibb and sanofi-aventis’ Plavix (clopidogrel bisulfate). The results came from a large Phase III clinical study with more than 13,000 patients.

In patients with diabetes, prasugrel reduced the risk of cardiovascular death, nonfatal heart attacks and nonfatal strokes by 30 percent.

However, 2.4 percent of prasugrel-treated patients experienced major bleeding compared with 1.8 percent of Plavix-treated patients. Life-threatening bleeding occurred in 1.4 percent of prasugrel patients compared with 0.9 percent of Plavix patients.

Eli Lilly and Daiichi Sankyo said they identified three major risk factors for significant bleeding — 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 FDA by the end of the year.