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OPTIMUS-3: Prasugrel bested off-label doses of clopidogrel in small population of patients with type 2 diabetes

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American Heart Association Scientific Sessions 2009

Patients with type 2 diabetes and coronary artery disease who received a 60-mg loading dose and 10-mg maintenance dose of prasugrel achieved significantly greater platelet inhibition compared with a 600-mg loading dose and 150-mg maintenance dose of clopidogrel.

The OPTIMUS-3 study researchers evaluated 35 patients with type 2 diabetes who also had CAD who were taking aspirin.

Within four hours, the level of platelet inhibition as measured using the VerifyNow P2Y12 Test with a 60-mg loading dose of prasugrel (Effient, Daiichi-Sankyo, Eli Lilly) was higher than observed with an off-label, 600 mg loading dose of clopidogrel (89% vs. 28%). In addition, one hour after the loading dose, patients who were assigned to prasugrel had 50% inhibition of platelet activation (IPA) compared with 13% in patients assigned to clopidogrel. The level of IPA achieved at four hours remained unchanged for the following 24 hours.

“This helps ground us on some of the other data we’ve seen,” LeRoy LeNarz, MD, senior medical director of Lilly U.S.A. told Cardiology Today.

After seven days, results showed that a 10-mg maintenance dose of prasugrel was associated with greater platelet inhibition than a 150-mg maintenance dose of clopidogrel (62% vs. 44%, P<.0001).

The study was conducted at four U.S. sites among patients who did not have a specific indication for clopidogrel therapy (more than 12 months after an acute coronary event or bare metal stent placement and no drug-eluting stent in place). This study did not establish the relationship between IPA and clinical activity.

“Previous research has shown that patients with type 2 diabetes have more active platelets, so they might be more prone to clotting than [patients without diabetes] and may have suboptimal response to therapies that reduce platelet activity,” Dominick Angiolillo, MD, PhD, assistant professor of medicine and director of CV research in the division of cardiology at University of Florida, Gainesville, said in a press release.

It’s a provocative study and supports the same findings of the original pivotal trial data.

– Roger Blumenthal, MD

Cardiology Today Preventive Cardiology Section Editorial Board member

For more information:

• Angiolillo D. Abstract 4946. Presented at: American Heart Association Scientific Sessions 2009; Nov. 14-18; Orlando, Fla.