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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

BARCELONA, Spain, Sept. 1 /PRNewswire/ -- 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 do
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SOURCE Kowa Company Ltd., Kowa Pharmaceuticals America, Inc., and Kowa Research Institute, Inc.
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