Daiichi Sankyo reports Prasugrel phase III PRASFIT-Elective study results

11th July 2013 (Last Updated July 11th, 2013 18:30)

Daiichi Sankyo has reported results from a phase III study of oral antiplatelet agent Prasugrel in patients with coronary artery disease in Japan.

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.