FLUVASTATIN EFFICACY AND TOLERABILITY IN COMPARISON AND IN COMBINATION WITH CHOLESTYRAMINE

The aim of this study was to investigate the new synthetic HMG-CoA red uctase inhibitor, fluvastatin, for efficacy, safety and tolerability i n comparison to cholestyramine. One hundred fifty one primary hypercho lesterolaemic patients participated in this double-blind, parallel-gro up, randomized study. During the first 12 weeks of the study, fluvasta tin (20 mg and 40 mg daily) was compared with cholestyramine (16 g per day). In the subsequent, 6-week part of the study, the comparative ef ficacy, safety and tolerability of 20 mg fluvastatin, combined with ch olestyramine (4 g, 8 g, or 16 g) were assessed. Fluvastatin (40 mg) re duced LDL cholesterol by 28.0%, triglycerides by 10.5% and increased H DL cholesterol by 3.7%. Cholestyramine (16 g) reduced LDL cholesterol by 35.0%, but raised triglycerides and HDL cholesterol by 12.3% (p < 0 .01) and 3.7% respectively. The combination of fluvastatin 20 mg and c holestyramine (4 g, 8 g and 16 g) induced the following reductions in LDL cholesterol: 30.4%, 35.6 % and 46.6% respectively. There was no si gnificant change in triglycerides in either group although HDL cholest erol was raised by 4.9%, 8.3% and 7.2% respectively. One patient treat ed with fluvastatin and two treated with cholestyramine were withdrawn from the study due to elevation of liver transaminases. The most freq uent subjective adverse effects in both treatment groups were mild, tr ansient gastrointestinal complaints. Thus, fluvastatin was effective a s a lipid-lowering agent; the effect was further enhanced when fluvast atin was combined with cholestyramine.