In a randomized trial in Nigeria among 300 Black African patients with uncontrolled hypertension who were either untreated or receiving a single blood pressure–lowering drug, treatment with low-dose triple-pill protocol, compared with standard-care protocol, for 6 months significantly reduced home systolic blood pressure (by 5.8 mm Hg), with no increase in discontinuation of trial treatment due to adverse events:
- participants were randomly allocated to low-dose triple-pill or standard-care protocols.
- triple-pill protocol involved a novel combination of telmisartan, amlodipine, and indapamide in triple one-quarter, one-half, and standard doses (ie, 10/1.25/0.625 mg, 20/2.5/1.25 mg, and 40/5/2.5 mg), with accelerated up-titration
- standard-care protocol was the Nigeria hypertension treatment protocol starting with amlodipine (5 mg)
- Main Outcomes and Measures
- primary effectiveness outcome was the reduction in home mean systolic blood pressure, and the primary safety outcome was discontinuation of trial treatment due to adverse events, both from randomization to month 6
- Results
- at month 6, clinic blood pressure control (<140/90 mm Hg) was 82% vs 72% (risk difference, 10% [95% CI, −2% to 20%]) and home blood pressure control (<130/80 mm Hg) was 62% vs 28% (risk difference, 33% [95% CI, 22% to 44%]) in the triple-pill compared with the standard-care protocol group; these were 2 of 21 prespecified secondary effectiveness end points. No participants discontinued trial treatment due to adverse events
Conclusion:
- compared with standard-care protocol, treatment with a low-dose triple-pill protocol can improve blood pressure lowering
Reference:
- Dike B et al. Low-Dose Triple-Pill vs Standard-Care Protocols for Hypertension Treatment in Nigeria - A Randomized Clinical Trial. JAMA. 2024;332(13):1070-1079. doi:10.1001/jama.2024.18080