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

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.