01 Jun 2012, BioSpectrum Bureau , BioSpectrum
Singapore: Kowa Pharmaceuticals America and Eli Lilly and Company revealed results of the PREVAIL study that was held in the US. The research involved studying Pitavastatin compared with pravastatin in lowering LDL-C and evaluated the efficacy of LIVALO (pitavastatin) 4 mg as compared to pravastatin 40 mg in reducing low-density lipoprotein cholesterol (LDL-C). The study also evaluated the primary endpoint, as well as effects on other lipid parameters and lipoprotein particles in adult patients with primary hyperlipidemia or mixed dyslipidemia.
PREVAIL US was designed as a superiority trial for the primary endpoint, LDL-C reduction, and evaluated the adult population age 18-to-80 with primary hyperlipidemia or mixed dyslipidemia. LIVALO 4 mg showed superior LDL-C reduction as compared to pravastatin 40 mg after 12 weeks of therapy. However, the study did not compare LIVALO 4 mg with pravastatin 80 mg.
Data for secondary endpoints showed that LIVALO 4 mg reduced apolipoprotein B (Apo-B), non-HDL-C, and total cholesterol when compared with pravastatin 40 mg and also improved high-density lipoprotein cholesterol (HDL-C) and triglycerides (TG). Furthermore, 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.
Dr Craig Sponseller, VP, medical affairs, Kowa Pharmaceuticals America, said that, "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 US study investigator, Dr Kari Uusinarkaus, fellow, 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."