Key result
Treatment with amlodipine 5 mg in adults with HIV and prehypertension reduced mean systolic blood pressure by 5.9 mmHg (95% CI -8.8 to -3.0) compared to control at 12 months.
Why the study?
Elevated blood pressure, even at prehypertensive levels, increases cardiovascular disease risk among people with HIV, yet international guidelines in low-income countries recommend initiating treatment only at blood pressure of at least 140/90 mmHg.
Does amlodipine 5 mg reduce systolic blood pressure in adults with HIV and prehypertension?
RCT (n=250)
Unblinded
Randomized
No
Does amlodipine 5 mg reduce systolic blood pressure in adults with HIV and prehypertension?
In adults with HIV and prehypertension in a resource-poor setting, treatment with amlodipine 5 mg significantly reduced systolic blood pressure and incident hypertension compared to standard care.
Supports earlier BP treatment in PWH; challenges guidelines starting antihypertensives only at ≥140/90 mmHg.
OBJECTIVE: 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. DESIGN: An unblinded randomized clinical trial (enrolled April 2021-March 2022) with 12-month follow-up. SETTING: GHESKIO Centres, Port-au-Prince, Haiti. PARTICIPANTS: 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. INTERVENTION: Participants were randomized to treatment (amlodipine 5 mg) or control (no amlodipine unless two BP ≥140/90 mmHg). MAIN OUTCOME MEASURE: Primary outcome was mean change in SBP between intervention versus control groups from enrollment to 12 months. RESULTS: 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. CONCLUSION: In PWH in a resource-poor setting, prehypertension treatment was feasible, acceptable, and effective in reducing mean SBP and incident hypertension. REGISTRATION: Clinicaltrials.gov NCT04692467.
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Yan et al. (2024) conducted an RCT in HIV with prehypertension (n=250). amlodipine vs. no amlodipine unless two BP ≥140/90 mmHg was evaluated on mean change in SBP between intervention versus control groups from enrollment to 12 months (MD -5.9, 95% CI -8.8 to -3.0). Treatment with amlodipine 5 mg in adults with HIV and prehypertension reduced mean systolic blood pressure by 5.9 mmHg (95% CI -8.8 to -3.0) compared to control at 12 months.
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