Abstract
Background: To compare the cholesterol-lowering potency of fluvastatin and lovastatin, a randomized, prospective. open-label parallel study was conducted in patients eligible for drug therapy by National Cholesterol Education Program guidelines. The study was conducted at eight centers in the United States.
Methods and Results: Patients were required to follow a cholesterol-lowering diet and were withdrawn from all lipid-lowering agents for 4 weeks prior to study entry. Patients were randomized to receive lovastatin 20 mg or fluvastatin 20 mg daily for 6 weeks. The two treatment groups were comparable with respect to demographic and clinical characteristics. Baseline lipid levels in the two groups were comparable. Lovastatin was significantly more effective than fluvastatin in lowering total cholesterol (-19.5% vs-12.8%, P <.001) and low-density lipoprotein cholesterol (-27.6% vs-18.2%. P <.001). Changes in high-density lipoprotein and triglyceride levels were comparable in the two groups. The differences in cholesterol lowering were similar in the three strata of coronary heart disease risk factor status as defined by the second NCEP Adult Treatment Panel. Both treatments were well tolerated.
Conclusions: Treatment of patients with combined hyperlipidemia and/or low high-density lipoprotein with combination low-dose simvastatin and niacin resulted in large reductions in total, low-density lipoprotein, and very low-density lipoprotein cholesterol and increases in HDL cholesterol. Although the combination was well tolerated in the current trial, its safety needs to be evaluated in larger trials of longer duration.
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