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 randomi zed, 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 l ipoprotein (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 fluvasta tin. After 52 weeks of therapy, 75% of patients were receiving fluvast atin at 40 mg/day Cmean dose: 36 +/- 8 mg/day). The mean percent chang e in LDL-cholesterol levels from baseline was - 24.8% (p < 0.001), and 82.6% of patients achieved an LDL-cholesterol reduction of greater th an 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, triglycer ides were significantly (p < 0.001) reduced by 15.3%. plasma lipoparti cle (a) [Lp(a)]:B levels were also significantly reduced (- 38.6%; p < 0.001). Fluvastatin was considered to be well tolerated by the majori ty of patients by both patients and investigators. The most freqnently reported adverse event was abdominal pain. Notable biochemical abnorm alities 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 ac companied by no particular problems of safety.