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.
"We are very pleased with the results of PREVAIL U.S., which are consistent with previous trials evaluating LIVALO's effect on LDL-C reduction," said Dr. Craig Sponseller, Vice President of Medical Affairs at Kowa Pharmaceuticals America, Inc. "Although the clinical relevance of these data require further study, these data are important as they represent the first of such particle analysis with LIVALO."
PREVAIL U.S. study investigator, Dr. Kari Uusinarkaus, Fellow of the National Lipid Association, and Associate Medical Director, Adult Primary Care and Disease Management Departments, Colorado Springs Health Partners, explains, "We continue to research and pursue a greater understanding on the effect of lipid-modifying agents, particularly statins, on lipoprotein particles and the use of direct measures of particle number and size in advancing our clinical assessment of dyslipidemia and its treatment."
Kowa Pharmaceuticals America, Inc. and Eli Lilly and Company
Kowa Pharmaceuticals America, Inc. and Eli Lilly and Company (NYSE: LLY) today 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. Study results were presented during two poster sessions at the National Lipid Association's (NLA) Scientific Sessions in Scottsdale, Arizona.