Eli Lilly and Company (LLY) and Kowa Pharmaceuticals America Inc., Thursday jointly announced the results of the PREVAIL U.S. study which evaluated the efficacy of LIVALO 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.
The two companies noted that 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.
"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."
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