Efficacy of a low dose-range of fluvastatin (XU 62-320) in the treatment of primary hypercholesterolaemia. A dose-response study in 431 patients. The French-Dutch Fluvastatin Study Group.

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Abstract
1. In this randomised, double‐blind, placebo‐controlled study, the efficacy of four dosages of fluvastatin (2.5, 5, 10 and 20 mg day‐1) were assessed in 431 patients with primary hypercholesterolaemia recruited in 17 centres. 2. Following an 8‐week dietary stabilisation phase and a 6‐week placebo phase, the patients were randomised to receive placebo or fluvastatin 2.5, 5, 10 or 20 mg once daily at night for a period of 6 weeks. 3. Total cholesterol, beta‐quant LDL‐C, and the beta‐quant LDL‐C/HDL‐C ratio were significantly reduced by all doses of fluvastatin, and HDL‐C was significantly increased by the 10 mg and 20 mg doses. Fluvastatin 20 mg day‐1 also significantly decreased TG and Lp(a):B levels. 4. Fluvastatin was well tolerated during the study, and relatively few biochemical or haematological abnormalities occurred. 5. Of the dosages tested, 20 mg fluvastatin day‐ 1 is the optimal hypolipidaemic dose.