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KMID : 0391020110190020073
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Journal of Korean Society for Clinical Pharmacology and Therapeutics
2011 Volume.19 No. 2 p.73 ~ p.83
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Influence of Simvastatin on Pharmacokinetics/Pharmacodynamics of Aspirin after Oral Co-administration in Healthy Volunteers
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Gu Nam-Yi
Kim Bo-Hyung
Chung Yong-Ju
Lim Kyoung-Soo
Seo Hyo-Bum
Yim Dong-Seok
Shin Sang-Goo
Jang In-Jin
Yu Kyung-Sang
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Abstract
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Background: Both aspirin and simvastatin are prescribed as treatments or prevention of cardiovascular diseases. The aim of this study was to investigate the influence of simvastatin on pharmacokinetics and pharmacodynamics of aspirin after oral co-administration in healthy subjects.
Methods: Subjects were orally administered aspirin 100 mg for 7 days followed by co-administration of aspirin 100 mg and simvastatin 40 mg for 7 days once daily. A series of blood samples were collected before and till 24hours after drug administration on Day 1 (single-dose of aspirin), Day 7 (multiple-dose of aspirin) and Day 14 (multiple-dose of aspirin and simvastatin). The effects of simvastatin on pharmacokinetics of acetylsalicylic acid and salicylic acid were assessed with the 90 % confidence intervals (CIs) of thegeometric mean ratios (GMRs) of Day 14 over Day 7 for maximum plasma concentration () and the area under the concentration-time curve (). Pharmacodynamics was assessed with maximal changes of platelet aggregation from baseline.
Results: Twenty-fourhealthy men aged 20 to 36 years were enrolled and 23 of them completed the study. GMRs (90 % CIs) of and for acetylsalicylic acid were 1.21 (1.04 - 1.42) and 1.28 (1.19 - 1.38), respectively. For salicylic acid, GMRs of and were 0.96 (0.91 - 1.00) and 1.00 (0.97 - 1.04), respectively. Maximal changes of platelet aggregation on Day 7 and Day 14 from baseline were not significantly different (p=0.41); % and %, respectively.
Conclusion: Coadministration of simvastatin slightly increased the systemic exposure of acetylsalicylic acid with no changes of systemic exposure of salicylic acid or inhibition of platelet aggregation.
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KEYWORD
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Aspirin, Simvastatin, Drug interactions, Pharmacokinetics, Platelet aggregation
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