Comparison of Prasugrel Vs. High-dose Clopidogrel in Patients with Type 2 Diabetes Mellitus and CAD: Results of the OPTIMUS-3 trial
The Optimizing Antiplatelet Therapy in Diabetes Mellitus (OPTIMUS)-3 Study  was a prospective, randomized, double-blind, double-dummy, active-controlled, two-period study conducted to compare the use of standard-dose prasugrel with double-dose clopidogrel in patients with type 2 diabetes mellitus (DM) whose coronary artery disease had been determined by multiple platelet function assays. Generally, when medications are needed to prevent ischemic events, patients with DM are at increased atherothrombotic risk because of enhanced platelet reactivity and reduced response to oral antiplatelet medications. Therefore, investigators in the OPTIMUS-3 study sought to determine whether greater platelet inhibition in patients with DM would be achieved with prasugrel when compared with the use of double-dose clopidogrel.
Between April of 2008 and January of 2009, 35 patients were enrolled at four academic sites in the US. Patients were randomized to receive either prasugrel 60 mg loading dose (LD) with a 10 mg maintenance dose (MD) or clopidogrel 600 mg LD with a MD of 150 mg over two 1-week treatment periods, separated by a 2-week washout period. Primary endpoint was inhibition of platelet aggression (IPA) measured by the Verify-Now® P2Y12 assay 4 hours (4 h) after the administration of the study drug LD. At the primary end-point of 4 h post-LD, patients treated with prasugrel had greater IPA compared with clopidogrel: 89.3% (95% Confidence Interval [CI], 83.0–96.6) vs. 27.7% (95% CI, 21.5–33.9, P<0.0001). The difference between prasugrel and clopidogrel-treated patients was significant at all time points from 1 h post-LD through 7 days.
The investigators concluded that standard-dose prasugrel provides greater platelet inhibition and response profiles during both loading and maintenance periods than double-dose clopidogrel in patients with type 2 DM.
 Angiolillo DJ, Badimon JJ, Saucedo JF, et al. A pharmacodynamic comparison of prasugrel vs. high-dose clopidogrel in patients with type 2 diabetes mellitus and coronary artery disease: results of the Optimizing anti-Platelet Therapy In diabetes MellitUS (OPTIMUS)-3 Trial. Eur Heart J 2011;32:838-46
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