Key result
Coadministration of fluvastatin and clopidogrel had no clinically relevant effect on fluvastatin pharmacokinetics (AUC was similar, Cmax increased 15.7%) or platelet inhibition.
Why the study?
Does coadministration of clopidogrel and fluvastatin affect fluvastatin pharmacokinetics or platelet function in healthy volunteers?
Does coadministration of clopidogrel and fluvastatin affect fluvastatin pharmacokinetics or platelet function in healthy volunteers?
Coadministration of fluvastatin and clopidogrel has no clinically relevant effect on fluvastatin pharmacokinetics or clopidogrel's antiplatelet efficacy.
This study assessed the effects of clopidogrel, a CYP 2C9 inhibitor, on fluvastatin pharmacokinetics in healthy volunteers. The effects of combined clopidogrel-fluvastatin treatment on platelet function were also determined. Subjects received 80 mg fluvastatin (extended-release formulation) alone on days 1 through 9, 80 mg fluvastatin and 300 mg clopidogrel (loading dose) on day 10, and 80 mg fluvastatin and 75 mg clopidogrel (maintenance dose) on days 11 through 19. Compared to treatment with fluvastatin alone, fluvastatin AUC was similar and C(max) increased marginally (15.7%) with concomitant treatment with clopidogrel. Platelet aggregation was inhibited by clopidogrel by 33% two hours after the loading dose and by 47% at steady state, similar to that reported for clopidogrel alone treatment. The authors conclude that coadministration of fluvastatin and clopidogrel has no clinically relevant effect on fluvastatin pharmacokinetics or on platelet inhibition by clopidogrel.
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Ayalasomayajula et al. (2007) studied Healthy volunteers. Clopidogrel vs. Fluvastatin alone was evaluated on Fluvastatin pharmacokinetics (AUC and Cmax) (15.7% increase in C(max)). Coadministration of fluvastatin and clopidogrel had no clinically relevant effect on fluvastatin pharmacokinetics (AUC was similar, Cmax increased 15.7%) or platelet inhibition.
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