Comparison of fluvastatin versus pravastatin treatment of primary hypercholesterolemia

Abstract Following a 6-week placebo period, 134 patients with low density lipoprotein cholesterol (LDL-C) ≥160 mg/dL and plasma triglyceride ≤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 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. The results of this study show that the lipid-lowering effect of fluvastatin at 40 mg daily is similar to that of pravastatin at 20 mg daily. Doubling the dosage to 80 mg of fluvastatin (40 mg twice daily) or 40 mg of pravastatin leads to a statistically significant further reduction in LDL-C with fluvastatin but not pravastatin. The tolerability of the two regimens is comparable.