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Kowa Pharmaceuticals America, Inc. and Eli Lilly and Company Announces Results of PREVAIL U.S. Study


Thursday, 31 May 2012 06:00am EDT 

Kowa Pharmaceuticals America, Inc. and Eli Lilly and Company announced results of the PREVAIL U.S. study (Pitavastatin compaREd with praVAstatin In Lowering LDL-C in the U.S.) which evaluated the efficacy of LIVALO (pitavastatin) 4 mg compared with pravastatin 40 mg in reducing low-density lipoprotein cholesterol (LDL-C), the primary endpoint, as well as effects on other lipid parameters and lipoprotein particles in adult patients with primary hyperlipidemia or mixed dyslipidemia. PREVAIL U.S. was designed as a superiority trial for the primary endpoint, LDL-C reduction, and evaluated the adult population age 18-80 with primary hyperlipidemia or mixed dyslipidemia. LIVALO 4 mg showed superior LDL-C reduction compared with pravastatin 40 mg after 12 weeks of therapy. The study did not compare LIVALO 4 mg with pravastatin 80 mg. Data for secondary endpoints showed LIVALO 4 mg reduced apolipoprotein B (Apo-B), non-HDL-C, and total cholesterol compared with pravastatin 40 mg and improved high-density lipoprotein cholesterol (HDL-C) and triglycerides (TG). In addition, the effect of LIVALO and pravastatin on individual lipoprotein particles was evaluated as a pre-specified exploratory analysis using nuclear magnetic resonance (NMR) spectroscopy. LIVALO showed significantly greater reductions in total LDL particle (LDL-P) concentration and increases in HDL particle (HDL-P) concentration and size. 

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