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.