Long-term treatment of hypercholesterolemia with fluvastatin: A 52-week multicenter safety and efficacy study

Abstract In this long-term (52-week) open-label extension to an earlier randomized, multicenter, double-blind, placebo-controlled, dose-finding trial, 381 patients with primary hypercholesterolemia received fluvastatin at increasing doses of 10 to 40 mg/day to achieve plasma low-density lipoprotein (LDL) cholesterol normalization, according to the European Atherosclerosis Society guidelines. The aim of the extension study was to assess the long-term efficacy, safety, and tolerability of fluvastatin. After 52 weeks of therapy, 75% of patients were receiving fluvastatin at 40 mg/day (mean dose: 36 ± 8 mg/day). The mean percent change in LDL-cholesterol levels from baseline was −24.8% (p