Efficacy and tolerability of fluvastatin in a titration dosage regimen in hyperlipidaemic patients: Results of a multicentre phase IV study

Objectives: The primary objective of this study was to determine the percentage of patients who reached the reduction goal in LDL-cholesterol (LDL-C) with fluvastatin dosage titration, if necessary combined with gemfibrozil, in an unselected patient population with primary hyperlipidaemia, after appropriate dietary intervention. A secondary objective of the study was to determine long-term safety in terms of liver and muscle enzymes and tolerability in terms of spontaneously reported adverse effects. Patients and Study Design: In this open-label, dosage titration study in 1501 male and female patients, we compared the 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitor fluvastatin in four possible dosage regimens - 20mg, 40mg, 80mg and, if necessary, 80mg combined with gemfibrozil 1200mg - over a period of 1 year. Results: In total, 61.8% of the patients recruited reached the desired LDL-C level for their coronary heart disease (CHD) risk category, i.e. <3.5 mmol/L for patients without CHD and <3.0 mmol/L for patients with CHD. The safety parameters ALT, AST and CPK were, in comparison with baseline, slightly higher in the fluvastatin 40mg, 80mg and 80mg plus gemfibrozil 1200mg groups. There was no difference in tolerability in terms of type of complaints and total number of complaints between the different treatment regimens. Conclusion: This study shows that fluvastatin is an effective and well tolerated cholesterol-lowering compound in patients with mild hypercholesterolaemia.