美国麻省总医院和哈佛医学院Steven K. Grinspoon团队研究了匹伐他汀在感染艾滋病毒时预防心血管疾病的效果。相关论文于2023年7月23日发表在《新英格兰医学杂志》上。

人类免疫缺陷病毒（HIV）感染者患心血管疾病的风险增加，因此需要有关该人群初级预防策略的数据。

在这项3期临床试验中，研究组随机分配了7769名接受抗逆转录病毒治疗的低至中度心血管疾病风险的HIV感染参与者，每天接受匹伐他汀钙（剂量为4 mg）或安慰剂治疗。主要结局是发生重大心血管不良事件，该事件被定义为心血管死亡、心肌梗死、因不稳定型心绞痛住院、中风、短暂性脑缺血发作、外周动脉缺血、血运重建或不明原因死亡的复合事件。

参与者的中位年龄为50岁（四分位间距为45至55岁）；CD4计数的中位数为621个细胞/立方毫米（四分位间距为448至827），根据现有数据，5997名参与者中5250人（87.5%）的HIV RNA值低于定量。在中位随访5.1年（四分位间距4.3至5.9）后，试验因疗效提前停止。匹伐他汀组的重大心血管不良事件发生率为4.81/1000人年，安慰剂组为7.32/1000人年（危险比为0.65；P=0.002）。匹伐他汀组91名参与者（2.3%）和安慰剂组53名参与者（1.4%）出现肌肉相关症状；糖尿病发生率分别为206例（5.3%）和155例（4.0%）。

研究结果表明，在5.1年的中位随访中，接受匹伐他汀治疗的HIV感染参与者发生重大心血管不良事件的风险低于接受安慰剂治疗的参与者。

附：英文原文

Title: Pitavastatin to Prevent Cardiovascular Disease in HIV Infection

Author: Steven K. Grinspoon, M.D.,, Kathleen V. Fitch, M.S.N.,, Markella V. Zanni, M.D.,, Carl J. Fichtenbaum, M.D.,, Triin Umbleja, M.S.,, Judith A. Aberg, M.D.,, Edgar T. Overton, M.D.,, Carlos D. Malvestutto, M.D., M.P.H.,, Gerald S. Bloomfield, M.D., M.P.H.,, Judith S. Currier, M.D.,, Esteban Martinez, M.D., Ph.D.,, Jhoanna C. Roa, M.D.,, Marissa R. Diggs, B.A.,, Evelynne S. Fulda, B.A.,, Kayla Paradis, M.B.A.,, Stephen D. Wiviott, M.D.,, Borek Foldyna, M.D.,, Sara E. Looby, Ph.D.,, Patrice Desvigne-Nickens, M.D.,, Beverly Alston-Smith, M.D.,, Jorge Leon-Cruz, M.S.,, Sara McCallum, M.P.H.,, Udo Hoffmann, M.D., M.P.H.,, Michael T. Lu, M.D., M.P.H.,, Heather J. Ribaudo, Ph.D.,, and Pamela S. Douglas, M.D.

Issue&Volume: 2023-07-23

Abstract:

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.

DOI: 10.1056/NEJMoa2304146

Source: https://www.nejm.org/doi/full/10.1056/NEJMoa2304146