Small D, Payne C, Stauffer M, Li Y, Knadler Mary-Pat, Altamirano A, Ríos-Rodríguez BE

Language: Spanish
References: 10
Page: 68-73
PDF size: 315.14 Kb.

ABSTRACT

Introduction: The thienopyridine prasugrel was shown in TRITON-TIMI 38, a large phase 3 trial, to be more effective than clopidogrel in reducing the rate of ischemic events in patients with acute coronary syndromes undergoing percutaneous coronary intervention. However, that trial did not enroll subjects in Mexico. Objective: To characterize the pharmacokinetic (PK) and pharmacodynamic (PD) effects of prasugrel in healthy Mexican subjects. Material and methods: Twenty-four subjects were given a single dose of 60 mg prasugrel, followed by 7 once-daily doses of 10 mg prasugrel. Plasma concentrations of prasugrel’s active metabolite (Pras-AM) and its effect on adenosine diphosphate (ADP)-induced platelet aggregation were measured. Results: The mean (coeffecient of variation) area-under-curve of Pras-AM was 561 ng•h /mL (27%) following 60-mg prasugrel and 74.2 ng•h/mL (29%) following the final 10-mg dose. The 60-mg dose produced complete inhibition of ADP-induced platelet aggregation in most subjects by 2 hours post dose. Daily 10-mg doses maintained › 90% inhibition as measured using the Accumetrics^® VerifyNow^® P2Y12 assay. Prasugrel was well tolerated in healthy Mexican subjects in this study. Conclusions: The PK and PD effects of prasugrel, and its safety profile, in healthy Mexican subjects are similar to those in healthy Caucasian populations.

REFERENCES

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