Studies conducted by Kowa showed that the patients treated with Livavo (pitavastatin), high-density lipoprotein cholesterol (HDL-C) concentrations increased, and nearly three-fourths of patients attained low-density lipoprotein cholesterol (LDL-C) targets. The results sustained over 52 weeks.
Livavo was found to have comparable efficacy to atorvastatin and simvastatin, as measured by reduction in LDL-C from baseline. The phase III data were presented at the European Society of Cardiology Congress (ESC) in Spain.
The primary objective of the two phase III, double-blind, active-controlled studies was to demonstrate non-inferiority of Livavo to atorvastatin and simvastatin, as measured by the reduction of LDL-C.
In addition to that the secondary objectives of the study were to assess National Cholesterol Education Program (NCEP) and European Atherosclerosis Society (EAS) LDL-C target attainment, other lipid and lipoprotein fractions, safety and tolerability.
An open-label extension study was also conducted to assess the long-term safety and tolerability of Livavo 4mg once daily for up to 52 weeks.
Roger Morgan, chief medical officer of Kowa Research Institute, said: Data from these pivotal, phase III studies show that Livavo has a robust efficacy, safety and tolerability profile, and in terms of LDL-C reduction, stands up to atorvastatin and simvastatin at usual therapeutic doses.
With sustained efficacy, low rates of discontinuation due to adverse events and steady, progressive increases in HDL-C observed over 52 weeks, Livavo shows great promise for the long-term treatment of patients with hypercholesterolemia or mixed dyslipidemia.