Daiichi Sankyo Company has reported results from Phase III study of an oral antiplatelet agent Prasugrel in patients with coronary artery disease in Japan.
The multi-centre, randomised, double-blind Prasugrel for Japanese patients with coronary artery disease undergoing elective PCI (PRASFIT-Elective) study evaluated the efficacy and safety of Prasugrel plus aspirin. Clopidogrel plus aspirin was used as a reference for patients with stable angina and chronic myocardial infarction undergoing elective percutaneous coronary intervention (PCI).
The rate of composite incidence of cardiovascular death, non-fatal myocardial infarction and non-fatal ischemic stroke was 4.1% in the Prasugrel group compared to 6.7% in the clopidogrel sulfate group.
The rate of non-coronary artery bypass graft (CABG) TIMI major, minor or clinically relevant bleeding was 5.4% in the Prasugrel group compared to 6.2% in the clopidogrel group.
There was no incidence of non-CABG TIMI major bleeding noted in the Prasugrel group while the figure was 2.2% in the clopidogrel group. Similar efficacy and safety results to these were observed in the prior PRASFIT-ACS study.
On the basis of results from the PRASFIT-ACS and PRASFIT-Elective studies, Daiichi Sankyo submitted a new drug application to the Ministry of Health, Labour and Welfare in Japan for patients with ischemic heart disease undergoing PCI.
A phase III trial of Prasugrel for patients with ischemic cerebrovascular disease is also being carried out in Japan. It is expected to be completed in 2014.