High-density lipoprotein cholesterol concentrations increased in patients treated with LIVALO

Sep 2 2009

New data presented today showed that in patients treated with LIVALO (pitavastatin), high-density lipoprotein cholesterol (HDL-C) concentrations increased, and nearly three-fourths of patients attained low-density lipoprotein cholesterol (LDL-C) targets, with results sustained over 52 weeks. Additionally, LIVALO 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 Barcelona, Spain.

"These studies confirm that the efficacy of LIVALO is comparable to other commonly used statins, and that it is an effective and well tolerated long-term treatment option for patients," said Leiv Ose, M.D. Ph.D., Rikshospitalet University Hospital, Norway, and study investigator. "With many patients not reaching LDL-C targets with current statin therapies due to a number of factors, including noncompliance and the risk for drug-drug interactions, there is a need for a statin that has the potential to improve long-term treatment."

The primary objective of the two Phase III, double-blind, active-controlled studies was to demonstrate non-inferiority of LIVALO to atorvastatin and simvastatin, as measured by the reduction of LDL-C. 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 LIVALO 4 mg once daily for up to 52 weeks.

"Data from these pivotal, Phase III studies show that LIVALO 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," said Roger E. Morgan, M.D., Chief Medical Officer, Kowa Research Institute. "With sustained efficacy, low rates of discontinuation due to adverse events and steady, progressive increases in HDL-C observed over 52 weeks, LIVALO shows great promise for the long-term treatment of patients with hypercholesterolemia or mixed dyslipidemia."

Study 1

A total of 830 patients were randomized to one of four treatment groups: LIVALO (2 mg or 4 mg) or atorvastatin (10 mg or 20 mg), once daily. Results showed that LIVALO was comparable to atorvastatin in terms of reduction in LDL-C, and no significant differences emerged in the other endpoints. Adverse events with LIVALO and atorvastatin were also similar.

Study 2

A total of 857 patients were randomized to LIVALO (2 mg or 4 mg) or simvastatin (20 mg or 40 mg), once daily. Results showed that LIVALO 4 mg and simvastatin 40 mg were comparable in LDLC reduction, with low-dose LIVALO (2 mg) resulting in a greater reduction in LDL-C than simvastatin 20 mg. Additionally, low-dose LIVALO also showed significantly better decreases in total cholesterol and non-HDL-C than simvastatin 20 mg. Moreover, the percentage of patients who met the LDL-C goal, according to EAS guidelines, was also greater with low-dose LIVALO compared with simvastatin 20 mg. The tolerability profiles of LIVALO and simvastatin were similar.

Extension Study

The extension study demonstrated a favorable safety and tolerability profile for LIVALO 4 mg over the 52-week trial. Reductions in LDL-C were sustained over the 52-week period. In addition, a higher proportion of LIVALO-treated patients met the defined LDL-C target at the end of the extension study than at the end of the core study (74.0% NCEP and 73.5% EAS). Steady increases in HDL-C were observed throughout the extension period, reaching more than 14%.

Source: http://www.kowapharma.com