Background:
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.
Methods:
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.
Results:
The baseline characteristics of the two groups were similar. 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). 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.
Conclusions:
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).
