Efficacy and safety of once-daily vs twice-daily dosing with fluvastatin, a synthetic reductase inhibitor, in primary hypercholesterolemia

William Insull, Donald Black, Carlos Dujovne, James D. Hosking, Donald Hunninghake, Leonard Keilson, Robert Knopp, James McKenney, Evan Stein, August J. Troendle, Jackson T. Wright

Research output: Contribution to journalArticle

38 Scopus citations

Abstract

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.

Original languageEnglish (US)
Pages (from-to)2449-2455
Number of pages7
JournalArchives of Internal Medicine
Volume154
Issue number21
DOIs
StatePublished - Nov 14 1994

ASJC Scopus subject areas

  • Internal Medicine

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