Phase IV study of Livalo (Eli Lilly/Kowa Pharmaceuticals) meets end point in patients with Dyslipidemia

Results of a Phase IV study evaluating the efficacy of Livalo (pitavastatin), from Eli Lilly/Kowa Pharmaceuticals, compared with pravastatin in reducing low-density lipoprotein cholesterol (LDL-C) in HIV-infected adults with Dyslipidemia has met its end point. Results showed that, after 12 weeks of therapy, pitavastatin had a significantly greater decrease in LDL-C compared with pravastatin (pitavastatin -49.4 mg/dL and pravastatin -33.6 mg/dL, 31% vs 21% reduction in LDL-C, respectively, p<0.001).>

The overall incidence of treatment emergent adverse events (TEAEs) was 61.1% for pitavastatin and 62.7% for pravastatin. The most frequently reported TEAEs overall (in more than 2% of subjects in either treatment group) included diarrhea, upper respiratory tract infection and sinusitis. The study investigator was Dr. Judith Aberg, Director of Virology, Bellevue Hospital Center and Director, Division of Infectious Diseases and Immunology, NYU School of Medicine. Results were presented at the 20th Conference on Retroviruses & Opportunistic Infections.