Comparison of fluvastatin versus pravastatin treatment of primary hypercholesterolemia. French Fluvastatin Study Group.
Following a 6-week placebo period, 134 patients with low density lipoprotein cholesterol (LDL-C) > or = 160 mg/dL and plasma triglyceride < or = 400 mg/dL, despite following a standard lipid-lowering diet, were randomized to double-blind, double-placebo treatment with fluvastatin (22 women, 46 men; age 21-71 years) or pravastatin (25 women, 41 men; age 19-76 years). Fluvastatin at 40 mg and pravastatin at 20 mg were given for the first 4 weeks, both once daily with the evening meal. For the following 12 weeks, fluvastatin at 40 mg twice daily and pravastatin at 40 mg once daily were given with the evening meal. Both drugs were equally effective in lowering LDL-C after 4 weeks of treatment (-24.0% with fluvastatin, -24.1% with pravastatin) but, after 16 weeks, LDL-C reduction was -30.4% with fluvastatin and -26.6% with pravastatin. This further lowering of LDL-C between week 4 and week 16 was significant (p < 0.001) for fluvastatin but not pravastatin. Adverse events were reported by 23 fluvastatin patients and 22 pravastatin patients: 3 patients in each group withdrew from the study because of these. No notable abnormalities in levels of alanine or aspartate aminotransferase values (defined as > 3 times the upper limit of normal on 2 consecutive occasions) or of creatine phosphokinase (defined as > 10 times the upper limit of normal on any occasion) were observed in either treatment group.(ABSTRACT TRUNCATED AT 250 WORDS)
Jacotot
B
B
Sandoz S.A. France.
Benghozi
R
R
Pfister
P
P
Holmes
D
D
D000328:Adult; D000368:Aged; D000410:Alanine Transaminase / Q000097:blood; D000924:Anticholesteremic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001219:Aspartate Aminotransferases / Q000097:blood; D002784:Cholesterol / Q000097:blood; D008076:Cholesterol, HDL / Q000097:blood; D008078:Cholesterol, LDL / Q000097:blood; D003402:Creatine Kinase / Q000097:blood; D004311:Double-Blind Method; D005229:Fatty Acids, Monounsaturated / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D000077340:Fluvastatin; D006801:Humans; D006903:Hydroxymethylglutaryl CoA Reductases / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D006937:Hypercholesterolemia / Q000097:blood / Q000188:drug therapy*; D007211:Indoles / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D010919:Placebos; D017035:Pravastatin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D014280:Triglycerides / Q000097:blood
D000924:Anticholesteremic Agents; D008076:Cholesterol, HDL; D008078:Cholesterol, LDL; D005229:Fatty Acids, Monounsaturated; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D007211:Indoles; D010919:Placebos; D014280:Triglycerides; D000077340:Fluvastatin; D002784:Cholesterol; D006903:Hydroxymethylglutaryl CoA Reductases; D001219:Aspartate Aminotransferases; D000410:Alanine Transaminase; D003402:Creatine Kinase; D017035:Pravastatin