Many patients with severe primary
hypercholesterolemia--
low density lipoprotein cholesterol (
LDL-C) > 240 mg/dL--have heterozygous
familial hypercholesterolemia. In such familial hypercholesterolemic patients, the
lipid-lowering efficacy of
fluvastatin is related to genetic factors, and it is of interest whether the response to treatment differs from that in patients with more moderate
hypercholesterolemia. Thus an exploratory analysis of randomized, controlled clinical trials and their open-label extensions (12-78 weeks), conducted worldwide with
fluvastatin > or = 20 mg/day (n = 1810) and placebo (n = 783), assessed whether, apart from the potential differences between familial hypercholesterolemic and nonfamilial hypercholesterolemic patients, the response to 40 mg of
fluvastatin is influenced by baseline plasma
lipid levels in relation to disease severity. Entry criteria included
LDL-C > or = 190 mg/dL with < or = 1 risk factor and no
coronary artery disease, or > or = 160 mg/dL with > 1 risk factor or definite
coronary artery disease. Of these patients, 591 (33%) given
fluvastatin (20-40 mg/day) and 187 (24%) given placebo had severe
hypercholesterolemia with baseline
LDL-C > 240 mg/dL. In controlled studies, the mean +/- SD duration of exposure was 21.1 +/- 16.1 and 19.4 +/- 15.5 weeks for
fluvastatin and placebo, respectively, whereas long-term efficacy was assessed after 55.3 +/- 21.7 weeks (
fluvastatin) and 21.1 +/- 12.3 weeks (
fluvastatin +
cholestyramine, after previous monotherapy). In summary,
fluvastatin at 40 mg/day lowered
LDL-C by 25-26% from baseline in controlled studies (n = 622), and by 27% in long-term studies (32-33% with
fluvastatin +
cholestyramine; n = 386), irrespective of severity of cholesterolemia.(ABSTRACT TRUNCATED AT 250 WORDS)