DOUBLE-BLIND COMPARISON OF THE EFFICACY AND TOLERABILITY OF SIMVASTATIN AND FLUVASTATIN IN PATIENTS WITH PRIMARY HYPERCHOLESTEROLEMIA

The clinical efficacy and tolerability of simvastatin and fluvastatin were compared in 432 patients with primary hypercholesterolaemia in a multinational, randomised, double-blind trial. Following at least 10 w eeks on a lipid-lowering diet, patients continuing to have a total cho lesterol level greater than or equal to 6.5 mmol/L and elevated low de nsity lipoprotein (LDL) cholesterol levels received 6 weeks of once-da ily treatment with either simvastatin 5 mg (n = 109), simvastatin 10 m g (n = 110), fluvastatin 20 mg (n = 105), or fluvastatin 40 mg (n = 10 8). The relative potency rates of simvastatin to fluvastatin in reduci ng LDL and total cholesterol levels were estimated to be 7.60 and 7.65 , respectively. Significantly greater mean reductions in LDL cholester ol levels were found at week 6 with simvastatin 10 mg (30%) compared w ith either fluvastatin 20 mg (22%; p < 0.001) or fluvastatin 40 mg (26 %; p = 0.03). Similarly, LDL cholesterol was lowered more in the simva statin 5 mg group (26%) than in the fluvastatin 20 mg group (22%; p = 0.03). No significant difference was seen between simvastatin 5 mg and fluvastatin 40 mg. Plasma total cholesterol levels were also signific antly lower with simvastatin 10 mg compared with fluvastatin 20 mg (23 vs 16%; p < 0.001) and fluvastatin 40 mg (23 vs 19%; p = 0.02), and w ith simvastatin 5 mg compared with fluvastatin 20 mg (19 vs 16%; p = 0 .01). Simvastatin 5 mg and fluvastatin 40 mg both lowered total choles terol levels by 19%. The percentage of patients reaching National Chol esterol Education Program Adult Treatment Panel II (NCEP ATP II) targe t LDL cholesterol levels after 6 weeks' treatment with simvastatin 5 o r 10 mg/day or fluvastatin 20 or 40 mg/day was 24, 25, 12 and 21%, res pectively. Tolerability profiles were generally similar, although sign ificantly more gastrointestinal adverse events occurred in the fluvast atin-treated patients (23 vs 11%). In conclusion, simvastatin 10 mg/da y is more effective in lowering total and LDL cholesterol levels than the maximum recommended dose of fluvastatin (40 mg/day), whereas simva statin 5 mg/day and fluvastatin 40 mg/day showed similar efficacy.