Influence of gender on the pharmacokinetics, safety, and tolerability of cerivastatin in healthy adults

European Journal of Clinical Pharmacology
J IsaacsohnA H Heller

Abstract

The pharmacokinetics, safety, and tolerability of cerivastatin, a synthetic HMG-CoA reductase inhibitor were studied in 49 healthy volunteers. In this double-blind, parallel group, multiple-dose study, volunteers were randomized as age-matched, male-female pairs and stratified into younger (18-65 years, premenopausal females) or older (65-85 years, postmenopausal females) groups. Thirty-two (16 female, 16 male) subjects received 0.2 mg cerivastatin daily for 7 days; 17 received placebo. Between all males and females, no differences in cerivastatin pharmacokinetics were observed. The AUCnorm in older females was 21% higher than in older males, while the AUCnorm in younger females was 26% lower than in younger males. The Cmax in older females was 30% higher than in age-matched males or younger males and females. All other pharmacokinetic parameters, including half-life, tmax, accumulation ratios, and steady state plasma levels were similar in all treatment groups. The most common adverse events, including headache (4), dyspepsia (4), and rash (4), were equally distributed between groups. Treatment-emergent elevations (< 2 x ULN) in creatine kinase occurred in one subject. Transaminase elevations occurred in nine subjects, most we...Continue Reading

Citations

Jan 23, 2002·Pharmacoepidemiology and Drug Safety
Apr 6, 2002·Circulation Research·Carmen UrbichStefanie Dimmeler
Jul 6, 2005·European Heart Journal·Nicoline JochmannVerena Stangl
Apr 26, 2018·BioMed Research International·Xiao LiangQinghua Zhao

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