RENAL DYSFUNCTION DOES NOT ALTER THE PHARMACOKINETICS OR LDL-CHOLESTEROL REDUCTION OF ATORVASTATIN

The objective of this study was to determine the effects of renal dysf unction on the steady-state pharmacokinetics and pharmacodynamics of a torvastatin, a 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibit or, Nineteen subjects with calculated creatinine clearances ranging fr om 13 mL/min to 143 mL/min were administered 10 mg atorvastatin daily for 2 weeks. Pharmacokinetic parameters and lipid responses were analy zed by regression on calculated creatinine clearance. Correlations bet ween steady-state atorvastatin pharmacokinetic pharmacodynamic paramet ers and creatinine clearance were weak and, in general, did not achiev e statistical significance. Although the elimination rate constant, la mbda(z) (0.579), was significantly correlated with creatinine clearanc e, neither maximum plasma concentration (C-max, -0.361) nor oral clear ance (Cl/F, 0.306) were; thus, steady-state exposure is not altered. R enal impairment has no significant effect on pharmacodynamics and phar macokinetics of atorvastatin.