EFFICACY OF A LOW DOSE-RANGE OF FLUVASTATIN (XU-62-320) IN THE TREATMENT OF PRIMARY HYPERCHOLESTEROLEMIA - A DOSE-RESPONSE STUDY IN 431 PATIENTS

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.