Pharmacokinetic study of rosuvastatin in males and females.

ABSTRACT

Rosuvastatin is used to treat dyslipidemia and is metabolized by CYP2C9 that shows variable metabolic activity in males and females. Pharmacokinetics (PK) of drugs varies in males and females that may result in altered drug response and therapeutic efficacy. In current study, PK of rosuvastatin has been evaluated in males and females. A single oral dose (40 mg rosuvastatin), open-label and non-controlled PK study was arranged. A reversed phase HPLC method was applied for quantification of rosuvastatin in serum samples. PK parameters of rosuvastatin were compared in males and females by applying student t test at 95 % confidence interval. The C max, [Formula see text]and [Formula see text]of rosuvastatin was significantly higher (p < 0.05) in females compared with males. The Vd/F of rosuvastatin was insignificantly higher (p > 0.05) in males compared with females while CL/F was significantly (p < 0.05) faster in males when compared at 95 % confidence interval. Rosuvastatin plasma level was significantly high in females compared with males that may be a possible reason for higher incidence of cardiac myopathy and other side effects in females. The variation in PK of drugs in males and females may require dose adjustment for maximum therapeutic effectiveness and safety.