匹伐他汀预防 HIV 感染患者的心血管疾病。
Pitavastatin to Prevent Cardiovascular Disease in HIV Infection.
机构信息
From the Metabolism Unit (S.K.G., K.V.F., M.V.Z., M.R.D., E.S.F., S.E.L., S.M.), the Cardiovascular Imaging Research Center, Department of Radiology (K.P., B.F., M.T.L.), and the Yvonne L. Munn Center for Nursing Research (S.E.L.), Massachusetts General Hospital and Harvard Medical School, the Center for Biostatistics in AIDS Research, Harvard T.H. Chan School of Public Health (T.U., J.L.-C., H.J.R.), and the Thrombolysis in Myocardial Infarction Study Group, Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School (S.D.W.) - all in Boston; the Division of Infectious Diseases, University of Cincinnati College of Medicine, Cincinnati (C.J.F.), and the Division of Infectious Diseases, Ohio State University Medical Center, Columbus (C.D.M.); the Division of Infectious Diseases, Icahn School of Medicine at Mount Sinai, New York (J.A.A.); the Division of Infectious Diseases, University of Alabama at Birmingham, Birmingham (E.T.O.); the Department of Medicine, Duke Global Health Institute and Duke Clinical Research Institute, Duke University (G.S.B.), and Duke University Research Institute, Duke University School of Medicine (P.S.D.) - both in Durham, NC; the Division of Infectious Diseases, David Geffen School of Medicine, University of California, Los Angeles, Los Angeles (J.S.C.); the Infectious Diseases Service, Hospital Clinic and University of Barcelona, Barcelona, and CIBER de Enfermedades Infecciosas, Instituto de Salud Carlos III, Madrid - both in Spain (E.M.); DLH, Silver Spring (J.C.R.), and the Division of Cardiovascular Sciences, National Heart, Lung, and Blood Institute (P.D.-N.), and the Division of AIDS, National Institute of Allergy and Infectious Diseases (B.A.-S.), National Institutes of Health, Bethesda - all in Maryland; and Cleerly, Denver (U.H.).
出版信息
N Engl J Med. 2023 Aug 24;389(8):687-699. doi: 10.1056/NEJMoa2304146. Epub 2023 Jul 23.
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 group and in 53 (1.4%) in the placebo group; diabetes mellitus occurred in 206 participants (5.3%) and in 155 (4.0%), respectively.
CONCLUSIONS
Participants with HIV infection who received pitavastatin had a lower risk of a major adverse cardiovascular event than those who received placebo over a median follow-up of 5.1 years. (Funded by the National Institutes of Health and others; REPRIEVE ClinicalTrials.gov number, NCT02344290.).
背景
感染人类免疫缺陷病毒（HIV）的人群心血管疾病风险增加，因此需要此类人群一级预防策略的数据。
方法
在这项 3 期临床试验中，我们将 7769 名 HIV 感染且心血管疾病风险低至中度的患者随机分配，接受每日给予匹伐他汀钙（剂量 4mg）或安慰剂治疗。主要终点是主要不良心血管事件的发生，定义为心血管死亡、心肌梗死、不稳定型心绞痛住院、卒 中、短暂性脑缺血发作、外周动脉缺血、血运重建或原因不明的死亡的复合终点。
结果
参与者的中位年龄为 50 岁（四分位距，45 岁至 55 岁）；中位 CD4 计数为 621 个细胞/立方毫米（四分位距，448 个至 827 个），5997 名可获得数据的参与者中 5250 名（87.5%）的 HIV RNA 值低于定量检测下限。中位随访 5.1 年后（四分位距，4.3 岁至 5.9 岁）因疗效提前终止试验。匹伐他汀组的主要不良心血管事件发生率为每 1000 人年 4.81 例，安慰剂组为每 1000 人年 7.32 例（风险比，0.65；95%置信区间 [CI]，0.48 至 0.90；P=0.002）。匹伐他汀组有 91 名（2.3%）和安慰剂组有 53 名（1.4%）参与者出现肌肉相关症状；匹伐他汀组有 206 名（5.3%）和安慰剂组有 155 名（4.0%）参与者出现糖尿病。
结论
在中位随访 5.1 年期间，与安慰剂相比，接受匹伐他汀治疗的 HIV 感染者主要不良心血管事件的风险较低。（由美国国立卫生研究院和其他机构资助；REPRIEVE ClinicalTrials.gov 编号，NCT02344290。）
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