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Treatment of Prehypertension in People
Living With HIV: A Randomized Controlled Trial
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CROI 2024 March 3-6 Denver
Lily D. Yan1, Vanessa Rouzier2, Rodney Sufra2, Colette Guiteau2, Mirline Jean2, Fabyola Preval2, Joseph inddy2, Pierre Obed Fleurijean2, Alexandra Apollon2, Nour Mourra1, Myung Hee Lee2, Suzanne Oparil3, Marie Deschamps2, Jean W. Pape2, Margaret McNairy1
1Weill Cornell Medicine, New York, NY, USA, 2GHESKIO, Port-au-Prince, Haiti, 3University of Alabama at Birmingham, Birmingham, AL, USA
Elevated systolic blood pressure (SBP) >120 mmHg is associated with increased cardiovascular disease (CVD) risk and mortality among people living with HIV (PLWH). The dual burden of HIV and CVD is highest in low-middle income countries (LMIC), yet the World Health Organization recommends PLWH initiate medication at SBP/DBP ≥140/90 mmHg, despite lower thresholds for diabetes and renal disease. We conducted a randomized controlled trial to evaluate acceptability and mean change in SBP among PLWH with prehypertension who initiate first-line antihypertensive treatment in a LMIC. Hypertension is SBP >/= 140 / DBP >/= 90/. Pre-hypertension is SBP 120-139 / DBP 80-89. WHO treatment initiation for diabetes & chronic kidney disease is SBP >/= 130 or DBP >/= 90, and in general for adults including PWH.
A total of 250 PLWH were enrolled from GHESKIO's HIV Clinic, between March 2021 to April 2023 in Port-au-Prince, Haiti. Participants were 18-65 years old, on stable antiretroviral therapy ≥6 months, had prehypertension (SBP 120-139 mmHg or DBP 80-89 mmHg), not on antihypertensive treatment, and randomized to intervention (initiation of amlodipine 5mg) or control (no medication unless reached SBP/DBP ≥140/90) in a 1:1 ratio.
Participants were followed for 12 months with standardized clinic and community visits measuring CVD health behaviors, BPs, physical exam, imaging, and laboratory data. The primary outcome was difference in mean change in SBP between study arms, from enrollment to 12 months. Secondary outcomes were difference in mean change in DBP, acceptability, incident hypertension, and adverse events. We analyzed the primary outcome using a linear mixed-effects model accounting for repeated measures and correlations within subjects.
The baseline characteristics of the two groups were similar. Mean age 50 in early treatment group, 47 in SOC, 2.5 years on ART, 97% on TDF-3TC-DTG, 17% physical activity < 150 minutes/week, 97% <5 servings fruit/vegetables daily, median SBP 129 (1426-132) in early treatment arm & 128 (126-133) in SOC. Median DBP 78 (73-82) in early treatment arm and 77 (73-81) in SOC.
Mean SBP/DBP change over 12 months was -10.6/-8.9 mmHg in intervention and -4.6/-3.2 mmHg in control. The difference in mean change in BP between intervention vs control was SBP -5.8 mmHg (95%CI -8.77, -3.01), DBP -5.5 mmHg (95%CI -7.92, -3.16). For incident hypertension, the hazard ratio of intervention vs control was 0.43 (95%CI 0.26, 0.70): 39.5% for early treatment arm fir incident hypertension vs 64.2% in the SOC. The most common adverse events (26 total) were dizziness (13) and edema (5), and no serious adverse events were drug related. Participants and study staff reported high acceptability of amlodipine initiation. There were no effects on viral suppression.
Lowering BP threshold for antihyperintensive initiation among PWH (similar to diabetes & Chronic kidney disease) may be important tool for CVD prevention.
Treatment of prehypertension in PLWH compared to standard of care reduced BP and incident hypertension, with few adverse events. There is an urgent need for CVD prevention among PLWH with elevated BP, who have alarmingly high risk of CVD events and mortality. (ClinicalTrials.gov number, NCT04692467).
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