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New Superiority Trial Showed LIVALO® pitavastatin 4 mg Provided Significantly Greater LDL-C Reduction in HIV-Infected Adults with Dyslipidemia versus Pravastatin 40 mg


2013 MAR 18 (NewsRx) -- By a News Reporter-Staff News Editor at AIDS Weekly -- Kowa Pharmaceuticals America, Inc. and Eli Lilly and Company (NYSE:LLY) announced results of a study evaluating the efficacy of LIVALO(®) (pitavastatin) 4 mg compared with pravastatin 40 mg in reducing low-density lipoprotein cholesterol (LDL-C) in HIV-infected adults with high cholesterol, or dyslipidemia. The study was designed as a superiority trial for the primary endpoint, percent reduction in LDL-C, and evaluated HIV-infected adults with dyslipidemia; with and without viral Hepatitis B or C. The study met its primary endpoint.(1)

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 results were presented yesterday at a late-breaking poster presentation at the 20th Conference on Retroviruses & Opportunistic Infections (CROI) in Atlanta, GA.(1) ( )

Dyslipidemia is common in people with HIV infection.(2) HIV-infected adults are at an increased risk for cardiovascular disease due to many factors, including lipid abnormalities.(3 )

"We are pleased that the study objective was met, showing superiority of pitavastatin 4 mg to pravastatin 40 mg on LDL-C reduction in HIV-infected adults with dyslipidemia, and we look forward to further analysis of these data," said Dr. Craig Sponseller, Vice President of Medical Affairs, Kowa Pharmaceuticals America, Inc (see also Pharmaceutical Companies).

Study investigator, Dr. Judith Aberg, Director of Virology, Bellevue Hospital Center and Director, Division of Infectious Diseases and Immunology, NYU School of Medicine, said, "In HIV-infected patients with high cholesterol, data such as these represent an important step in understanding lipid management in this immunocompromised patient population."

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 >2% of subjects in either treatment group) included diarrhea (13 subjects, 5.2%), upper respiratory tract infection (13 subjects, 5.2%), sinusitis (12 subjects, 4.8%), headache (10 subjects, 4.0%), nausea (10 subjects, 4.0%), nasopharyngitis (9 subjects, 3.6%), and blood creatine phosphokinase increased (8 subjects, 3.2%). Eleven subjects were discontinued from the study due to a TEAE (4.4%).(1)

Keywords for this news article include: Kowa Pharmaceuticals America Inc. and Eli Lilly and Company, Pharmaceutical Companies, HIV/AIDS, Pravastatin, RNA Viruses, Hydrocarbons, Naphthalenes, Retroviridae, Dyslipidemias, HIV Infections, Vertebrate Viruses, Primate Lentiviruses, Viral Sexually Transmitted Diseases.

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Information in this article was accurate in March 18, 2013. The state of the art may have changed since the publication date. This material is designed to support, not replace, the relationship that exists between you and your doctor. Always discuss treatment options with a doctor who specializes in treating HIV.