Patients who were diabetic and diagnosed with acute coronary syndromes (ACS) were 40 per cent less likely to suffer a heart attack if they were treated with prasugrel vs. clopidogrel, according to a sub-group analysis of the Triton-TIMI 38 trial (8.2 per cent vs. 13.2 per cent, P<0.001). In addition, according to this same analysis, the combined rate of cardiovascular death, non-fatal heart attack and non-fatal stroke was reduced by 30 per cent in diabetes patients treated with prasugrel compared to those treated with clopidogrel (12.2 per cent vs. 17.0 per cent, P<0.001). In patients without diabetes, there was also improvement in outcomes with prasugrel, with the primary endpoint occurring in 9.2 per cent of patients treated with prasugrel and 10.6 per cent of patients treated with clopidogrel (P=0.02).
The diabetic sub-group analysis was presented by Stephen Wiviott, assistant Professor of Medicine at Harvard Medical School and investigator with the Thrombolysis in Myocardial Infarction (TIMI) Study Group, Brigham & Women's Hospital, Boston, USA, at the Congress of the European Society of Cardiology (ESC) in Munich, Germany. In addition, the manuscript was simultaneously published online in Circulation, the medical journal of the American Heart Association (AHA).
"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," said Wiviott.
The reduction of cardiovascular events was consistent across the sub-group of diabetes patients regardless of diabetic therapies (insulin versus no insulin). The study showed a significant relative risk reduction in the primary endpoint of cardiovascular death, non-fatal heart attack and non-fatal stroke with prasugrel, 37 per cent for insulin treated and 26 per cent (P=0.001) for non-insulin treated diabetics. There was also a significantly lower rate of stent thrombosis among diabetes patients treated with prasugrel, resulting in a 48 percent relative risk reduction in stent thrombosis compared with clopidogrel (3.6 per cent vs. 2.0 per cent, P=0.007).
"These findings are interesting in view of previous studies that showed higher levels of platelet aggregation in insulin-treated diabetes patients after dual antiplatelet therapy compared to diabetes patients not treated with insulin," said Dr Wiviott.
Daiichi Sankyo Company, Limited (TSE: 4568) and Eli Lilly and Company are co-developing prasugrel, an investigational oral antiplatelet agent invented by Daiichi Sankyo and its Japanese research partner Ube Industries, Ltd., as a potential treatment, initially for patients with acute coronary syndrome undergoing PCI.
A global pharma innovator, Daiichi Sankyo Co, Ltd, was established in 2005 through the merger of two leading Japanese pharmaceutical companies. This integration created a more robust organization that allows for continuous development of novel drugs that enrich the quality of life for patients around the world. A central focus of Daiichi Sankyo's research and development is cardiovascular disease, including therapies for dyslipidemia, hypertension, diabetes, and acute coronary syndrome. Equally important to the company is the discovery of new medicines in the areas of infectious diseases, cancer, bone and joint diseases, and immune disorders.
Lilly, a leading innovation-driven corporation, is developing a growing portfolio of first-in-class and best-in-class pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations.