Efficacy and safety of fluvastatin ER 80 mg compared with fluvastatin IR 40 mg in the treatment of primary hypercholesterolaemia

The efficacy and safety of once- or twice-daily immediate-release (IR) fluvastatin 40 mg were compared with those of the extended-release (XL) formulation of fluvastatin 80 mg every night (qpm), which facilitates sustained drug delivery. Patients (n=442) with primary hypercholesterolaemia (Fredrickson types IIa and lib) were randomised to the three treatment groups in the ratio 1:1:1. Active treatment was administered for 24 weeks, following a four-week placebo/dietary lead-in period. At week 24, the mean reduction in low density lipoprotein cholesterol levels in patients treated with fluvastatin XL 80 mg every night (qpm) (-33.5%) was significantly greater than in the fluvastatin IR 40 mg every night (qpm) group (-23.2%; p<0.001), and similar to the reduction for patients treated with fluvastatin IR 40 mg twice-daily (bid) (-31.4%). Significant and dose-related alterations in other lipid variables were also apparent, particularly for high density lipoprotein cholesterol (10.2% increase) and apolipoprotein A1 and B levels (+11.5% and -24.2%, respectively) in the fluvastatin XL 80 mg qpm group compared with the fluvastatin IR 40 mg qpm group (all p<0.001). Mean triglyceride levels decreased by 14.6% in the fluvastatin XL 80 mg qpm group. Adverse events were generally mild, with no differences in frequency across the groups. Fluvastatin XL 80 mg qpm is a safe and effective lipid-lowering treatment for patients with type II hypercholesterolaemia.