Magazine article Drug Topics

New Trials May Cut Clopidogrel Use

Magazine article Drug Topics

New Trials May Cut Clopidogrel Use

Article excerpt

Atrio of late-breaking clinical trials could change standard drug treatment for patients undergoing percutaneous coronary intervention, or PCI. Dual antiplatelet therapy, aspirin plus a thienopyridine, is standard to prevent dirombotic complications in patients with acute coronary syndrome (ACS) and those undergoing PCI.

A phase III trial, TRITON-TIMI 38, could open the door for a new diienopyridine agent-prasugrel (Daiichi Sankyo/Lilly)-to compete with clopidogrel (Plavix, sanofiaventis/Bristol-Meyers Squibb) to reduce complications in patients who have undergone PCI. And two trials support institutions that are replacing abciximab (ReoPro, Centocor/Lilly) with eptifibatide (Integrilin, Schering-Plough) to maintain coronary perfusion following PCI. The three trials were discussed at the American Heart Association's annual Scientific Sessions in Orlando, Fla., last month.


A head-to-head trial of prasugrel and clopidogrel concluded that prasugrel is more potent, works more quickly, and has more consistent antiplatelet activity. "There was an early and sustained benefit from prasugrel mat started with the loading dose [LD]," said Elliott Antman, M.D., professor of medicine at Harvard Medical School. "The benefits the higher degree of inhibition of platelet aggregation achieved with prasugrel in TRITON-TIMI 38 represent the latest advance in antiplatelet therapy."

The international trial enrolled 13,608 patients at 707 sites, Antman said. All of the patients had moderate- to high-risk ACS and were scheduled to undergo PCI. Patients were randomized to receive either prasugrel (60 mg LD plus 10 mg daily maintenance) or clopidogrel (300 mg LD plus 75 mg daily maintenance) following PCI. Treatment continued for up to 15 months after PCI.

Prasugrel significandy reduced myocardial infarction (MI), urgent target vessel revascularization, and stent thrombosis compared with clopidogrel, Antman reported. The downside of the new drug is increased bleeding. The risk of major bleeding was concentrated in patients with prior stroke or transient ischemic attack (TLA) and the frail elderly (over 75, weighing <60 kg), he added. "This is an approvable drug. But I would not give it to a patient with a prior stroke or TLA. Fully 80% of the individuals in this trial had a net clinical benefit from prasugrel. …

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