Pravastatin and fenofibrate in combination (Pravafenix®) for the treatment of high-risk patients with mixed hyperlipidemia

Pravafenix(®) is a fixed-dose combination of pravastatin 40 mg and fenofibrate 160 mg. The rationale for the use of Pravafenix is based on the increased residual cardiovascular risk observed for high-risk patients with either increased triglycerides or low HDL cholesterol levels despite statin monotherapy. This article reviews the current available information on the pharmacology, clinical efficacy and safety of Pravafenix. Pravafenix is recommended to be taken with food in the evening. In clinical trials, Pravafenix consistently produces complementary benefits on the overall atherogenic lipid profile of high-risk patients with mixed hyperlipidemia not controlled by either pravastatin 40 mg or simvastatin 20 mg. Within the limitations of the database, Pravafenix seems to be well tolerated up to 64 weeks, with an overall tolerability and safety profile consistent with findings generally observed with fenofibrate treatment. In particular, no myopathy or rhabdomyolysis has been reported. The actual European indication is restricted to high-risk patients with mixed hyperlipidemia whose LDL cholesterol levels are adequately controlled on pravastatin 40 mg monotherapy. Whether Pravafenix confers additional cardiovascular benefits in high-risk patients treated with a statin remains to be determined.