Study: Pitavastatin (Livalo) More Effective Than Pravastatin at Lowering LDL-C in HIV Patients
Dyslipidemia common with HIV infection (Mar. 7)
Results have been announced from a study that evaluated the efficacy of pitavastatin (Livalo, Kowa Pharmaceuticals/Eli Lilly) compared with pravastatin in reducing low-density lipoprotein cholesterol (LDL-C) in human immunodeficiency virus (HIV)-infected adults with 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 infection. The study met its primary endpoint.
A total of 252 patients were randomly assigned to receive once-daily doses of pitavastatin 4 mg or pravastatin 40 mg for 12 weeks. Pitavastatin achieved a significantly greater reduction in LDL-C compared with pravastatin (–49.4 mg/dL [31% reduction] vs. –33.6 mg/dL [21% reduction], respectively; P < 0.001). The results were presented at the 20th Conference on Retroviruses and Opportunistic Infections (CROI), held in Atlanta, Georgia.
Dyslipidemia is common in people with HIV infection. HIV-infected adults have an increased risk for cardiovascular disease due to many factors, including lipid abnormalities.
The overall incidence of treatment-emergent adverse events (AEs) was 61.1% for pitavastatin and 62.7% for pravastatin. The most frequently reported treatment-emergent AEs in either treatment group included diarrhea (5.2%), upper respiratory tract infection (5.2%), sinusitis (4.8%), headache (4.0%), nausea (4.0%), nasopharyngitis (3.6%), and blood creatine phosphokinase increased (3.2%).
Pitavastatin (Livalo) is an HMG-CoA reductase inhibitor indicated as an adjunctive therapy to diet to reduce elevated total cholesterol, LDL-C, apolipoprotein B, and triglycerides, and to increase high-density lipoprotein cholesterol (HDL-C) in adult patients with primary hyperlipidemia or mixed dyslipidemia. The drug was launched in the U.S. in June 2010.
Source: Eli Lilly; March 7, 2013.