Efficacy and safety of extended-release fluvastatin in Turkish patients with hypercholesterolaemia: TULIPS (Turkish Lipid Study)

Abstract

Objective: The efficacy and safety of extended-release fluvastatin (fluvastatin XL), 80 mg once daily, was assessed in Turkish patients with primary hypercholesterolaemia (low-density lipoprotein cholesterol (LDL-C) 3.37-5.70 mmol/l and triglyceride (TG) < 4.52 mmol/l).

Research design: In this open-label, prospective, multi-centre study, 154 patients were given fluvastatin XL 80 mg once daily and lipid levels were assessed after 2 and 12 weeks.

Results: Fluvastatin XL 80 mg once daily significantly reduced LDL-C levels by 38.8 and 38.1% at weeks 2 (n = 140) and 12 (n = 116), respectively (p < 0.001 vs. baseline). Treatment with fluvastatin XL for 2 and 12 weeks significantly reduced total cholesterol levels by 30.2 and 27.4%, respectively (p < 0.001 vs. baseline) and reduced TG levels by 14.9 and 7.5%, respectively (p < 0.001 vs. baseline). Following stratification by risk factors for coronary heart disease (CHD) according to the National Cholesterol Education Program Adult Treatment Panel III guidelines, 87.3% of patients with > or = 2 risk factors, and 67.4% of patients with existing CHD or CHD risk equivalents achieved target LDL-C levels (< 3.37 mmol/l and < 2.59 mmol/l, respectively) with fluvastatin XL. Fluvastatin XL reduced high-density lipoprotein cholesterol by 8.9 and 4.7% at weeks 2 and 12 weeks, respectively. fluvastatin XL 80 mg once daily was generally well-tolerated.

Conclusions: This open-label study indicates fluvastatin XL 80 mg once daily is an effective and well-tolerated lipid-lowering therapy for the reduction of CHD risk in Turkish patients.