LONG-TERM TREATMENT OF HYPERCHOLESTEROLEMIA WITH FLUVASTATIN - A 52-WEEK MULTICENTER SAFETY AND EFFICACY STUDY

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 longterm efficacy, safety, and tolerability of fluvastatin. After 52 weeks of therapy, 75% of patients were receiving fluvastatin at 40 mg/day Cmean dose: 36 +/- 8 mg/day). The mean percent change in LDL-cholesterol levels from baseline was - 24.8% (p < 0.001), and 82.6% of patients achieved an LDL-cholesterol reduction of greater than or equal to 15%. In patients in the lowest baseline quintile, high-density lipoprotein-cholesterol levels were significantly (p < 0.001) increased by 8.8% whereas, in the highest baseline quintile, triglycerides were significantly (p < 0.001) reduced by 15.3%. plasma lipoparticle (a) [Lp(a)]:B levels were also significantly reduced (- 38.6%; p < 0.001). Fluvastatin was considered to be well tolerated by the majority of patients by both patients and investigators. The most freqnently reported adverse event was abdominal pain. Notable biochemical abnormalities were rare. In conclusion, the results of this extension study indicate that fluvastatin at dosages of 20-40 mg/day is effective and well tolerated in patients with primary hypercholesterolemia and is accompanied by no particular problems of safety.