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.
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.
Jacotot
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B
Banga
J D
JD
Pfister
P
P
Mehra
M
M
D000328:Adult; D000368:Aged; D000704:Analysis of Variance; D000924:Anticholesteremic Agents / Q000008:administration & dosage / Q000494:pharmacology / Q000627:therapeutic use*; D015415:Biomarkers / Q000097:blood; D002784:Cholesterol / Q000097:blood; D008076:Cholesterol, HDL / Q000097:blood; D008078:Cholesterol, LDL / Q000097:blood; D015243:Cholesterol, VLDL / Q000097:blood; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005229:Fatty Acids, Monounsaturated / Q000008:administration & dosage / Q000494:pharmacology / Q000627:therapeutic use*; D005260:Female; D000077340:Fluvastatin; D005602:France; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D006937:Hypercholesterolemia / Q000188:drug therapy*; D007211:Indoles / Q000008:administration & dosage / Q000494:pharmacology / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D009426:Netherlands; D014280:Triglycerides / Q000097:blood
D000924:Anticholesteremic Agents; D015415:Biomarkers; D008076:Cholesterol, HDL; D008078:Cholesterol, LDL; D015243:Cholesterol, VLDL; D005229:Fatty Acids, Monounsaturated; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D007211:Indoles; D014280:Triglycerides; D000077340:Fluvastatin; D002784:Cholesterol