Rationale and design of the Randomized Trial to Prevent Vascular Events in HIV (REPRIEVE)
Rationale and design of the Randomized Trial to Prevent Vascular Events in HIV (REPRIEVE)
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DOI：
10.1016/j.ahj.2018.12.016
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发表时间：
2019-06-01
影响因子：
4.8
通讯作者：
Douglas, Pamela S.
中科院分区：
文献类型：
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作者：
Grinspoon, Steven K.;Fitch, Kathleen V.;Douglas, Pamela S.
背景 心血管疾病 (CVD) 在 HIV 感染者 (PWH) 中更为常见，可能与传统和非传统因素有关，包括炎症和免疫激活。迫切需要制定有效的策略来预防该人群的 CVD。 方法 预防 HIV 血管事件的随机试验 (REPRIEVE) (A5332) 是一项前瞻性、随机、安慰剂对照试验，研究他汀类药物策略对低至中度传统风险的感染者主要不良心血管事件 (MACE) 的一级预防。至少 7,500 名 40-75 岁的艾滋病患者将被随机分配接受匹伐他汀钙（4 毫克/天）或相同的安慰剂，并接受长达 8 年的稳定抗逆转录病毒治疗。参与者根据 2013 年美国心脏病学会 (ACC)/美国心脏协会 (AHA) 动脉粥样硬化性心血管疾病 (ASCVD) 风险评分和低密度脂蛋白胆固醇 (LDL-C) 水平进行招募，目的是确定可能受益于药物 CVD 预防策略的低至中度风险人群。风险评分为 7.5% 的潜在参与者（风险评分 LDL-C < 190 mg/dL
Background Cardiovascular disease (CVD) is more frequent among people with HIV (PWH) and may relate to traditional and nontraditional factors, including inflammation and immune activation. A critical need exists to develop effective strategies to prevent CVD in this population.Methods The Randomized Trial to Prevent Vascular Events in HIV (REPRIEVE) (A5332) is a prospective, randomized, placebocontrolled trial of a statin strategy for the primary prevention of major adverse cardiovascular events (MACE) in PWH with low to moderate traditional risk. At least 7,500 PWH, 40-75 years of age, on stable antiretroviral therapy, will be randomized to pitavastatin calcium (4 mg/d) or identical placebo and followed for up to 8 years. Participants are enrolled based on the 2013 American College of Cardiology (ACC)/American Heart Association (AHA) atherosclerotic cardiovascular disease (ASCVD) risk score and low-density lipoprotein cholesterol (LDL-C) level with a goal to identify a low- to moderate-risk population who might benefit from a pharmacologic CVD prevention strategy. Potential participants with a risk score 7.5% (LDL-C < 190 mg/dL for risk score