Effient approved for reduction of thrombotic cardiovascular events
EFFIENT (prasugrel) 5mg, 10mg tablets by Daiichi Sankyo and Eli Lilly
The FDA has approved Effient (prasugrel tablets, from Daiichi Sankyo and Eli Lilly), a platelet aggregation inhibitor, for the reduction of thrombotic cardiovascular events (including stent thrombosis) in patients with acute coronary syndrome (ACS) who are to be managed with percutaneous coronary intervention (PCI). This approval was based on results from the TRITON-TIMI 38 clinical trial which compared Effient with Plavix (clopidogrel bisulfate tablets, from Bristol-Myers Squibb and sanofi-aventis) in reducing cardiovascular events in 13,608 acute coronary patients managed with PCI. Effient taken with aspirin was shown to have a 19% relative risk reduction of the combined endpoint of cardiovascular death, non-fatal heart attack, or non-fatal stroke versus Plavix taken with aspirin. This benefit was seen as early as three days and continued over the 15 months of the trial. Effient also demonstrated an approximate 50% relative risk reduction in stent-related clots compared with Plavix. The risk of non-coronary artery bypass graft (non-CABG) related bleeding, however, was significantly higher with Effient (2.2%) compared to Plavix (1.7%). Analysis from TRITON-TIMI 38 which weighed the risk of major bleeding and the reduction in cardiovascular events found that for every 1,000 patients treated with Effient as compared to Plavix, there were 23 fewer patients with heart attacks and six more with major bleeding events.
Effient is expected to be available in August 2009 in 5mg and 10mg dosage strengths.