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November 14, 1994

Efficacy and Safety of Once-Daily vs Twice-Daily Dosing With Fluvastatin, a Synthetic Reductase Inhibitor, in Primary Hypercholesterolemia

Author Affiliations

From the Lipid Research Clinic, Baylor College of Medicine, The Methodist Hospital, Houston, (Dr Insull); The Christ Hospital, Cardiovascular Research Center, and Medical Research Laboratories, Cincinnati, (Drs Black and Stein); the Lipid and Atherosclerosis Prevention Clinic, Bell Memorial Hospital, Kansas City, Kan (Dr Dujovne); the Collaborative Studies Coordinating Center, Department of Biostatistics, University of North Carolina, Chapel Hill (Dr Hosking); the Heart Disease Prevention Clinic, University of Minnesota, Minneapolis (Dr Hunninghake); the Maine Medical Center, Portland (Dr Keilson); the Northwest Lipid Research Clinic, Seattle (Dr Knopp); the Medical College of Virginia, Richmond (Drs McKenney and Wright); and the Sandoz Research Inst, East Hanover, NJ (Dr Troendle).

Arch Intern Med. 1994;154(21):2449-2455. doi:10.1001/archinte.1994.00420210087010

Background:  Fluvastatin sodium is a new, entirely synthetic 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor that may be an effective lipid-lowering agent in patients whose hyperlipidemia does not respond to dietary therapy. We conducted a study to evaluate the effects of fluvastatin on lipoprotein levels in subjects with primary hypercholesterolemia and to compare the efficacy and safety of two fluvastatin sodium dosing regimens: 20 mg once daily vs 10 mg twice daily.

Design:  We conducted a double-blind, placebo-controlled, multicenter trial involving 207 patients with low-density lipoprotein cholesterol levels of 4.15 mmol/L (160 mg/dL) or higher despite dietary intervention and with triglyceride levels of 3.38 mmol/L or lower. Three parallel treatment groups received 6 weeks of treatment with 20 mg of fluvastatin sodium once daily, 10 mg of fluvastatin sodium twice daily, or a placebo.

Results:  Total cholesterol and low-density lipoprotein cholesterol levels were reduced from baseline by 16% and 22%, respectively, with 20 mg of fluvastatin sodium once daily (P<.001) and by 17% and 23%, respectively, with 10 mg of fluvastatin sodium twice daily (P<.001). Fluvastatin was well tolerated, and there were no serious clinical or biochemical adverse events ascribable to the drug.

Conclusions:  Fluvastatin therapy demonstrated excellent short-term safety and efficacy in reducing total and low-density lipoprotein cholesterol levels in patients with primary hypercholesterolemia. Fluvastatin sodium, the first totally synthetic 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor to be used in clinical trials, appears to be both effective and well tolerated at 20 mg/d, given in either a single or divided dose.(Arch Intern Med. 1994;154:2449-2455)