Efficacy and tolerability of fluvastatin and bezafibrate in patients with hyperlipidemia and persistently high triglyceride levels

Hyperlipidemia is an important cardiovascular risk factor. Lipid-lowering t herapy has been shown to decrease morbidity and mortality in these patients . Combination therapy with a 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA ) reductase inhibitor and a fibric-acid derivative has been reported to be more efficacious to reduce low-density lipoprotein (LDL) cholesterol and tr iglycerides but may be associated with an increased risk of myositis. The a im of this study was to investigate the efficacy and tolerability of fluvas tatin, an HMG-CoA reductase inhibitor, alone and in combination with bezafi brate, a fibric-acid derivative. In a randomized controlled trial with 454 hypercholesterolemic patients (mean cholesterol, 8.6 +/- 1.6 mM), fluvastat in (20 mg/day) significantly lowered total plasma cholesterol levels (-12.5 %; p < 0.0001 vs. placebo), LDL cholesterol (-14%; p < 0.0001), and triglyc erides (-4%; p = 0.05). A small increase in high-density lipoprotein (HDL) cholesterol levels (3%, NS) also was observed. Combination therapy with flu vastatin and bezafibrate (400 mg/day) in 71 patients with persistent hypert riglyceridemia during treatment with the statin resulted in a more pronounc ed reduction in triglyceride (-47%; p < 0.0001) and total cholesterol level s (-15%; p < 0.0001) than did fluvastatin alone. Furthermore, the additiona l bezafibrate significantly increased HDL cholesterol (+5%; p < 0.001). No significant increases in creatine phosphokinase levels or in frequency of m yalgia were observed. In summary, fluvastatin decreases both cholesterol an d triglyceride levels. In patients with persistent hypertriglyceridemia, co mbination therapy with fluvastatin and bezafibrate may be safely used to lo wer triglyceride and cholesterol levels more efficiently.