Eli Lilly and Daiichi Sankyo has presented data from a head-to-head study which shows that its investigational oral antiplatelet drug prasugrel could be more beneficial for diabetics than Sanofi-Aventis/Bristol-Myers Squibb’s blockbuster Plavix.
The study, presented at the European Society of Cardiology meeting in Munich, noted that there was a 13.2% reduction in the risk of patients with diabetes diagnosed with acute coronary syndromes having a subsequent heart attack when given prasugrel, compared with an 8.2% decrease for diabetics on Plavix (clopidogrel). The data, which comes from a sub-group analysis of the TRITON-TIMI 38 clinical trial, showed that in non-diabetics, there was also improvement in outcomes with prasugrel, with the primary endpoint occurring in 9.2% of patients, versus 10.6% on Plavix.
Presenting the data, Stephen Wiviott of the Brigham and Women’s Hospital in Boston, said that “the results observed from this sub-group analysis showed that antiplatelet therapy with prasugrel resulted in significantly greater reduction of cardiovascular events among patients with diabetes when compared to those who were treated with clopidogrel,”
September is a key month for prasugrel as the US Food and Drug Administration is scheduled to give its verdict on whether to approve the treatment on the 26th. Lilly and Daiichi Sankyo hope that the data from the TRITON trial which showed that prasugrel produced a 19% reduction in relative risk for cardiovascular death, non-fatal heart attack or non-fatal stroke when compared with Plavix, will be enough to get the thumbs-up from the agency.
Nevertheless, that data also revealed that prasugrel-treated patients also experienced a statistically significant increase in non-coronary artery bypass grafting major bleeding compared to Plavix.
