Kowa Pharmaceuticals America, Inc., a pharmaceutical company specializing primarily in the area of cardiometabolic diseases, and Eli Lilly and Company have reported 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 met its primary endpoint.

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.

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, Georgia.

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

"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.

Study investigator, Dr Judith Aberg, Director of Virology, Bellevue Hospital Centre 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 diarrhoea (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%).

In the 12-week, phase IV, randomized (1:1), double-blind, double-dummy, active-controlled, parallel-group study, 252 patients were randomized to receive once-daily doses of pitavastatin 4 mg or pravastatin 40 mg.  The primary efficacy analysis (ANCOVA) used percent change in LDL-C as the dependent variable, and treatment, site, and viral hepatitis B or C infection as independent variables. The major secondary lipid endpoints assessed were total cholesterol, HDL-C, non-HDL-C and triglycerides. Safety assessments included adverse events, clinical/ laboratory tests, HIV-1 RNA, CD4 count, and virologic failure.

LIVALO is a HMG-CoA reductase inhibitor indicated as an adjunctive therapy to diet to reduce elevated total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo B), triglycerides (TG), and to increase high-density lipoprotein cholesterol (HDL-C) in adult patients with primary hyperlipidemia or mixed dyslipidemia.

The effect of LIVALO on cardiovascular morbidity and mortality has not been determined. LIVALO has not been studied in Fredrickson Type I, III, and V dyslipidemias.

In addition to being launched in the U.S. in June 2010, LIVALO has been approved in Japan and 32 other countries as of January 2013.

Primary hyperlipidemia is defined as an elevation of cholesterol, particularly "bad" cholesterol (LDL-C), triglycerides (TG), or both. Mixed dyslipidemia is usually characterized by an elevation of LDL-C, TG, and a decrease in the "good" cholesterol (HDL-C) in the blood.

Kowa Company, Ltd. (KCL) is a privately held multinational company, is actively engaged in various manufacturing and commercial activities in the fields of pharmaceutical, life science, information technology, textiles, machinery and various consumer products.

Lilly, a leading innovation-driven corporation, is developing a growing portfolio of pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations.