Pravastatin sodium/Fenofibrate

Although LDL cholesterol is the primary treatment objective for reducing cardiovascular risk, the increase in triglyceride levels and the reduction of HDL cholesterol levels constitute the so-called residual cardiovascular risk. Treatment with statins combined with fibrates is an actual possibility for the treatment of overall cardiovascular risk. However, this combination is often associated with adverse eff ects, especially muscular and hepatic. Due to its pharmacological characteristics, the combination of pravastatin and fenofibrate can be effective and safe, with few adverse eff ects. In this review, we analyze the available safety studies and conclude that Pravafenix(®) (the combination of 40-mg pravastatin and 160-mg fenofibrate) achieves complementary benefits on the overall atherogenic lipid profile, is well tolerated and has few adverse eff ects, which is similar to the monotherapy of each of its components. It remains to be seen whether this combination confers additional long-term benefits for patients treated with statins.

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.