COMPARATIVE EFFICACY AND SAFETY OF MICRONIZED FENOFIBRATE AND SIMVASTATIN IN PATIENTS WITH PRIMARY TYPE IIA OR IIB HYPERLIPIDEMIA

Background: Few studies have been performed to compare fenofibrate, a second-generation fibrate, and simvastatin, a 3-hydroxy-3-methylglutar yl coenzyme A reductase inhibitor. This study was aimed to compare the efficacy of both drugs in reducing atherogenic risk factors in type I Ia or IIb hyperlipidemia. Methods: Sixty-three patients entered this s ingle-center, double-blind, crossover trial. Sixty patients (32 with t ype IIa and 28 with type IIb hyperlipidemia) were randomized to treatm ent for 3 months with a single daily 200-mg dose of micronized fenofib rate or 20 mg of simvastatin and then changed to the alternative treat ment for a further 3-month period. Results: After the first treatment period, in both types Ila and Ilb, fenofibrate and simvastatin produce d similar significant reductions in levels of total cholesterol and lo w-density lipoprotein cholesterol; high-density lipoprotein cholestero l levels were increased with both drugs in type IIb. Only renofibrate decreased total triglyceride levels in type IIb, Lp(a) lipoprotein lev els in patients with high baseline values, and fibrinogen. After the s econd period of treatment, in both types IIa and IIb, snitching from f enofibrate to simvastatin resulted in a further reduction in total cho lesterol and low-density lipoprotein cholesterol levels. The differenc e in the response of the two treatments on levels of total triglycerid es, Lp(a) lipoprotein, and fibrinogen was confirmed after changing ove r to the alternative treatment. This short-term study showed few adver se effects for both drugs. Conclusions: Fenofibrate and simvastatin pr ovide similar variations on total cholesterol and low-density lipoprot ein cholesterol levels after a 3-month treatment period, with simvasta tin having the capacity to decrease these measures further when admini stered after fenofibrate. However, fenofibrate exhibits a significant effect on other established risk factors, such as total triglyceride, fibrinogen, and Lp(a) lipoprotein levels, and accordingly has a broade r spectrum of activity than simvastatin.