Pitavastatin to Prevent Cardiovascular Disease in HIV Infection

作者：Steven Grinspoon, Kathleen V. Fitch, Markella V. Zanni, Carl J. Fichtenbaum, Triin Umbleja, Judith A. Aberg, Edgar T. Overton, Carlos Malvestutto, Gerald S. Bloomfield, Judith S. Currier, Estebán Martínez, Jhoanna C. Roa, Marissa R Diggs, Evelynne S. Fulda, Kayla Paradis, Stephen D. Wiviott, Borek Foldyna, Sara E. Looby, Patrice Desvigne‐Nickens, Beverly Alston‐Smith, Jorge Leon-Cruz, Sara McCallum, Udo Hoffmann, Michael T. Lu, Heather J. Ribaudo, Pamela S. Douglas · 发表于：New England Journal of Medicine · 年份：2023 · DOI：10.1056/nejmoa2304146 · 被引用次数：497 · 研究领域：HIV-related health complications and treatments、Lipoproteins and Cardiovascular Health、HIV/AIDS drug development and treatment

BACKGROUND: The risk of cardiovascular disease is increased among persons with human immunodeficiency virus (HIV) infection, so data regarding primary prevention strategies in this population are needed. METHODS: In this phase 3 trial, we randomly assigned 7769 participants with HIV infection with a low-to-moderate risk of cardiovascular disease who were receiving antiretroviral therapy to receive daily pitavastatin calcium (at a dose of 4 mg) or placebo. The primary outcome was the occurrence of a major adverse cardiovascular event, which was defined as a composite of cardiovascular death, myocardial infarction, hospitalization for unstable angina, stroke, transient ischemic attack, peripheral arterial ischemia, revascularization, or death from an undetermined cause. RESULTS: The median age of the participants was 50 years (interquartile range, 45 to 55); the median CD4 count was 621 cells per cubic millimeter (interquartile range, 448 to 827), and the HIV RNA value was below quantification in 5250 of 5997 participants (87.5%) with available data. The trial was stopped early for efficacy after a median follow-up of 5.1 years (interquartile range, 4.3 to 5.9). The incidence of a major adverse cardiovascular event was 4.81 per 1000 person-years in the pitavastatin group and 7.32 per 1000 person-years in the placebo group (hazard ratio, 0.65; 95% confidence interval [CI], 0.48 to 0.90; P = 0.002). Muscle-related symptoms occurred in 91 participants (2.3%) in the pitavastatin gr...