Long-term treatment with simvastatin in patients with familial combined hyperlipidemia

Simvastatin is a drug that inhibits 3-hydroxy-3-methylglutaryl-co-enzyme A reductase, the key enzyme in the synthesis of cholesterol. Simvastatin prevents mevalonate synthesis, thus reducing endogenous cholesterol production. The present study was performed to evaluate the efficacy and safety of simvastatin in the treatment of patients with familial combined hyperlipidemia who followed a hypolipidemic diet. Forty-two patients with familial combined hyperlipidemia (mean ± SD age, 65 ± 19 years; 24 men and 18 women) with baseline cholesterol levels higher than 250 mg/dL and serum triglyceride levels higher than 170 mg/dL and lower than 270 mg/dL were included in the study. All patients initially underwent 6 weeks of observation followed by adherence to a hypolipidemic diet for 6 weeks; subsequently, 23 patients received 20-mg simvastatin once daily and continued to follow the diet, while 19 patients were treated with diet only. The simvastatin treatment lasted 18 months and clinical and laboratory variables were monitored at given time points. Patients in the simvastatin group showed a significant reduction of total cholesterol, LDL cholesterol, and triglyceride levels, while HDL cholesterol levels increased significantly. During the treatment we did not observe serious drug-related clinical or laboratory side effects. In conclusion, therapy with simvastatin resulted in significant and sustained normalization of lipid profiles in patients with familial combined hyperlipidemia.