The Pharmaceutical Journal
Vol 279 No 7478 p555
17 November 2007

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Prasugrel cuts CV deaths but raises bleeding risk

Prasugrel is associated with fewer ischaemic events but more instances of bleeding than clopidogrel, a study of acute coronary syndromes patients scheduled to undergo percutaneous coronary intervention suggests (New England Journal of Medicine 2007;357:2001).

Death from cardiovascular causes, non-fatal myocardial infarction or non-fatal stroke (the study’s efficacy end point) occurred in 12.1 per cent of patients receiving clopidogrel, but in 9.9 per cent of patients receiving prasugrel (hazard ratio 0.81; 95 per cent confidence interval 0.73–0.90; P<0.001).

In addition, rates of myocardial infarction, urgent target-vessel revascularisation and stent thrombosis were lower in the prasugrel group.

However, instances of major bleeding occurred more frequently in the prasugrel group: 2.4 per cent of those receiving prasugrel suffered a major bleeding event, compared with 1.8 per cent of patients given clopidogrel (hazard ratio 1.32; 1.03–1.68; P=0.03). Although rates of life-threatening, non-fatal and fatal bleeding were all higher in the prasugrel group, the overall mortality rate did not differ across the two groups.

The researchers identified three groups of patients for whom prasugrel was less effective clinically and who also suffered more bleeding incidents: those with a history of stroke, the elderly and those with low body weight, all factors that have previously been associated with increased risk of adverse outcomes from antiplatelet or antithrombotic agents.

The authors conclude that clinicians should weigh the risks against the benefits of prasugrel’s intensive inhibition of platelet aggregation when considering the choice of treatment for patients with acute coronary syndromes.

The study enrolled 13,608 patients who had moderate- to high-risk acute coronary syndromes and were scheduled to undergo percutaneous coronary intervention. Patients received either prasugrel or clopidogrel for six to 15 months. Prasugrel was given as a 60mg loading dose and a 10mg daily maintenance dose. Clopidogrel was given as a 300mg loading dose and a 75mg daily maintenance dose.