1. Comparison of lipid-lowering effects of low-dose fluvastatin and conventional-dose gemfibrozil in patients with primary hypercholesterolemia
- Author
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Betteridge, D.J., Durrington, P.N., Fairhurst, G.J., Jackson, G., McEwan, M.S.R., McInnes, G.T., Miller, J.P., Mir, M.A., Reckless, J.P.D., Rees-Jones, D.I., Scarpello, J.H.B., Bard, J.-M., Fruchart, J.-C., Jewitt-Harris, J., Agnew, A.R., Peters, T.K., and Pfister, P.
- Subjects
Gemfibrozil -- Physiological aspects ,Anticholesteremic agents -- Physiological aspects ,Hypercholesterolemia -- Drug therapy ,Health ,Health care industry - Abstract
A total of 123 patients with Primary hypercholesterolemia were randomized on a 2:1 ratio to receive either fluvastatin at 20 mg once daily at night (n = 82) or gemfibrozil at 600 mg twice daily (n = 41) in a double-blind, double-dummy comparison of the effects on plasma lipid parameters and tolerability over 8 weeks. All patients had either low-density lipoprotein cholesterol (LDL-C) concentrations [greater than or equal to] 160 mg/dL (4.1 mmol/L) in association with definite coronary artery disease (CAD) or [greater than or equal to] 2 risk factors, or LDL-C [greater than or equal to] 190 mg/dL (4.9 mmol/L) with no CAD and 20% in LDL-C levels. Normalization of LDL-C levels was achieved (according to European Atherosclerosis Society guidelines) by 13.4% of fluvastatin- and 14.6% of gemfibrozil-treated patients. Both drugs were well tolerated; adverse events occurred in 36.6% of fluvastatin recipients compared with 58.5% of patients taking gemfibrozil. No clinically notable elevations of aspartate or alanine aminotransferases, alkaline phosphatase, or creatine phosphokinase occurred. No patient developed new or worsening lens opacities associated with a reduction in optically corrected visual acuity. The most commonly reported adverse events were headache and gastrointestinal upset. There were no serious drug-related adverse events.
- Published
- 1994