OBJECTIVES: The primary objective of this study was to demonstrate equivalence of pitavastatin compared with simvastatin in the reduction of low-density lipoprotein cholesterol (LDL-C) levels in patients with primary hypercholesterolaemia or combined dyslipidaemia. Secondary objectives included achievement of National Cholesterol Education Program Adult Treatment Panel (NECP) and European Atherosclerosis Society (EAS) LDL-C goals, comparison of other lipid parameters, and assessment of safety and tolerability of the two statins. RESEARCH DESIGN AND METHODS: A prospective, randomised, active-controlled double-blind, double-dummy, 12-week therapy trial was conducted in 857 patients with either primary hypercholesterolaemia or combined dyslipidaemia. The trial was designed to demonstrate the equivalence (non-inferiority of presumed equipotent doses) of pitavastatin compared with simvastatin. Patients were randomised to one of four groups: pitavastatin 2 mg/day, pitavastatin 4 mg/day, simvastatin 20 mg/day or simvastatin 40 mg/day. The main study limitation was restriction of the study population to those eligible for administration of simvastatin. TRIAL REGISTRATION: This clinical trial has been registered at www.clinicaltrials.gov NCT# NCT00309777. RESULTS:Pitavastatin 2 mg showed significantly better reductions of LDL-C (p = 0.014), non-high-density lipoprotein cholesterol (non-HDL-C) (p = 0.021) and total cholesterol (TC) (p = 0.041) compared with simvastatin 20 mg and led to more patients achieving the EAS LDL-C treatment target. Reduction of LDL-C in the pitavastatin 2 mg group was 39% compared with 35% in the simvastatin 20 mg group. Pitavastatin 4 mg showed similar effects on all lipid parameters to simvastatin 40 mg. The reductions in LDL-C were 44% and 43%, respectively. The safety profiles of pitavastatin and simvastatin were similar at the two dose levels. Pitavastatin was considered superior to simvastatin in terms of percent reduction of LDL-C in the lower dose group comparison and proved to be equivalent to simvastatin in percent reduction of LDL-C in the higher-dose group. CONCLUSION: As compared with simvastatin, an established first-line lipid-lowering agent, pitavastatin is an efficacious treatment choice in patients with primary hypercholesterolaemia or combined dyslipidaemia.
RCT Entities:
OBJECTIVES: The primary objective of this study was to demonstrate equivalence of pitavastatin compared with simvastatin in the reduction of low-density lipoprotein cholesterol (LDL-C) levels in patients with primary hypercholesterolaemia or combined dyslipidaemia. Secondary objectives included achievement of National Cholesterol Education Program Adult Treatment Panel (NECP) and European Atherosclerosis Society (EAS) LDL-C goals, comparison of other lipid parameters, and assessment of safety and tolerability of the two statins. RESEARCH DESIGN AND METHODS: A prospective, randomised, active-controlled double-blind, double-dummy, 12-week therapy trial was conducted in 857 patients with either primary hypercholesterolaemia or combined dyslipidaemia. The trial was designed to demonstrate the equivalence (non-inferiority of presumed equipotent doses) of pitavastatin compared with simvastatin. Patients were randomised to one of four groups: pitavastatin 2 mg/day, pitavastatin 4 mg/day, simvastatin 20 mg/day or simvastatin 40 mg/day. The main study limitation was restriction of the study population to those eligible for administration of simvastatin. TRIAL REGISTRATION: This clinical trial has been registered at www.clinicaltrials.gov NCT# NCT00309777. RESULTS:Pitavastatin 2 mg showed significantly better reductions of LDL-C (p = 0.014), non-high-density lipoprotein cholesterol (non-HDL-C) (p = 0.021) and total cholesterol (TC) (p = 0.041) compared with simvastatin 20 mg and led to more patients achieving the EAS LDL-C treatment target. Reduction of LDL-C in the pitavastatin 2 mg group was 39% compared with 35% in the simvastatin 20 mg group. Pitavastatin 4 mg showed similar effects on all lipid parameters to simvastatin 40 mg. The reductions in LDL-C were 44% and 43%, respectively. The safety profiles of pitavastatin and simvastatin were similar at the two dose levels. Pitavastatin was considered superior to simvastatin in terms of percent reduction of LDL-C in the lower dose group comparison and proved to be equivalent to simvastatin in percent reduction of LDL-C in the higher-dose group. CONCLUSION: As compared with simvastatin, an established first-line lipid-lowering agent, pitavastatin is an efficacious treatment choice in patients with primary hypercholesterolaemia or combined dyslipidaemia.