Yan Lily D, Rouzier Vanessa, Sufra Rodney, Sauveur Reichling St, Guiteau Colette, Lee Myung Hee, Ogyu Anju, Mourra Nour, Oparil Suzanne, Théard Michel, Brisma Jean Pierre, Alfred Jean Patrick, Deschamps Marie D, Pape Jean W, McNairy Margaret L
Center for Global Health.
Division of General Internal Medicine, Weill Cornell Medicine, NYC, New York, USA.
AIDS. 2025 Mar 1;39(3):261-269. doi: 10.1097/QAD.0000000000004065. Epub 2024 Nov 13.
Elevated blood pressure (BP), even at prehypertensive levels, increases cardiovascular disease risk among people with HIV (PWH); yet international guidelines in low-income countries recommend treatment initiation at BP at least 140/90 mmHg. We determined the efficacy, feasibility, and acceptability of treating prehypertension in PWH in Haiti.
An unblinded randomized clinical trial (enrolled April 2021-March 2022) with 12-month follow-up.
GHESKIO Centres, Port-au-Prince, Haiti.
Two hundred fifty adults with HIV with prehypertension (SBP 120-138 or DBP 80-89) not on medication, aged 18-65 years, virally suppressed, and without pregnancy, diabetes, or kidney disease.
Participants were randomized to treatment (amlodipine 5 mg) or control (no amlodipine unless two BP ≥140/90 mmHg).
Primary outcome was mean change in SBP between intervention versus control groups from enrollment to 12 months.
Among 250 adults, median age was 49 years, 40.8% were women. Baseline median BP was 129/78 mmHg intervention versus 128/77 mmHg control. After 12 months, the difference in mean change between study groups for SBP was -5.9 mmHg [95% confidence interval (95% CI) -8.8 to -3.0] and for DBP was -5.5 mmHg (95% CI -7.9 to -3.2). At 12 months, 5.6% intervention and 23.0% control participants developed incident hypertension (hazard ratio 0.18; 95% CI 0.07-0.47). There were no differences in viral load suppression at 12 months or drug-related serious adverse events. Intervention acceptability was high among providers and participants in qualitative interviews.
In PWH in a resource-poor setting, prehypertension treatment was feasible, acceptable, and effective in reducing mean SBP and incident hypertension.
Clinicaltrials.gov NCT04692467.
血压（BP）升高，即使处于高血压前期水平，也会增加艾滋病毒感染者（PWH）患心血管疾病的风险；然而，低收入国家的国际指南建议血压至少达到140/90 mmHg时开始治疗。我们确定了在海地对PWH进行高血压前期治疗的疗效、可行性和可接受性。
一项开放标签的随机临床试验（2021年4月至2022年3月入组），随访12个月。
海地太子港的GHESKIO中心。
250名未接受药物治疗的患有高血压前期（收缩压120 - 138或舒张压80 - 89）的艾滋病毒感染成人，年龄在18 - 65岁之间，病毒得到抑制，且未怀孕、患有糖尿病或肾病。
参与者被随机分为治疗组（氨氯地平5毫克）或对照组（除非两次血压≥140/90 mmHg，否则不使用氨氯地平）。
主要结局是干预组与对照组从入组到12个月期间收缩压的平均变化。
在250名成年人中，年龄中位数为49岁，40.8%为女性。干预组基线收缩压中位数为129/78 mmHg，对照组为128/77 mmHg。12个月后，研究组间收缩压平均变化差异为 -5.9 mmHg [95%置信区间（95%CI）-8.8至 -3.0]，舒张压差异为 -5.5 mmHg（95%CI -7.9至 -3.2）。在12个月时，5.6%的干预组参与者和23.0%的对照组参与者发生新发高血压（风险比0.18；95%CI 0.07 - 0.47）。12个月时病毒载量抑制情况及药物相关严重不良事件方面无差异。在定性访谈中，提供者和参与者对干预的接受度较高。
在资源匮乏环境下的PWH中，高血压前期治疗在降低平均收缩压和新发高血压方面是可行、可接受且有效的。
Clinicaltrials.gov NCT04692467
