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LIVALO(R) Demonstrates Sustained, Long-Term Efficacy and Tolerability in Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia
Date:9/1/2009

ses," 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%
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SOURCE Kowa Company Ltd., Kowa Pharmaceuticals America, Inc., and Kowa Research Institute, Inc.
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