Comparison of pitavastatin with simvastatin in primary hypercholesterolaemia or combined dyslipidaemia.

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.