LACK OF DRUG-DRUG INTERACTION BETWEEN CERIVASTATIN AND NIFEDIPINE

Cerivastatin is a novel, potent HMG-CoA reductase inhibitor. It is pri marily cleared via demethylation and hydroxylation with involvement of cytochrome P450 (CYP) 3A4 and subsequent biliary and renal excretion of the metabolites. Both cerivastatin and the dihydropyridine calcium antagonist nifedipine, which is primarily metabolized by CYP 3A4, are used concomitantly in the prevention and therapy of coronary heart dis ease. To study the drug-drug interaction potential, the mutual effects of cerivastatin and nifedipine were investigated in a controlled, ran domized, non-blind 3-way crossover study in healthy male subjects. Sin gle oral doses of 0.3 mg cerivastatin or of 60 mg nifedipine were admi nistered either alone or concomitantly under fasting conditions. The m ean AUC- and C-max ratios (combination treatment versus monotherapy) i ncluding 90% confidence intervals were 1.04 (0.98 - 1.10) and 1.00 (0. 93 - 1.07) for cerivastatin, and 0.98 (0.73 - 1.32) and 0.95 (0.80 - 1 .13) for nifedipine, respectively. Our results indicate that no mutual drug-drug interaction between cerivastatin and nifedipine occurs.