article · JAMA
A multicentre clinical trial conducted in public hospital clinics in Nigeria evaluated a novel low-dose triple-pill strategy for managing uncontrolled high blood pressure in Black African adults. The trial compared standard care starting with single-drug therapy against a combination pill combining telmisartan, amlodipine, and indapamide at quarter, half, and standard doses with accelerated titration. Over six months, patients using the triple-pill protocol experienced a greater reduction in home systolic blood pressure, achieving an average reduction of 31 mm Hg compared to 26 mm Hg in the standard-care group. Furthermore, home blood pressure control was achieved by 62 percent of triple-pill recipients versus 28 percent on standard care. Neither strategy led to treatment discontinuations caused by adverse events, showing that the triple-pill regimen delivers superior blood pressure reduction with favourable tolerability.
Hypertension represents a major health burden in sub-Saharan Africa, creating a critical demand for safe and scalable management strategies. Demonstrating that combining three blood pressure medications at low doses into a single pill outperforms existing single-drug care provides healthcare providers with a practical approach to achieving faster, superior blood pressure control without increasing treatment discontinuations.
The findings support the clinical application of a single-pill triple combination combining telmisartan, amlodipine, and indapamide for hypertension management. The primary users would be healthcare providers and patients in public and private health systems. Having demonstrated effectiveness and safety in a randomised clinical trial in public hospital clinics, this pharmaceutical intervention appears applied and clinically tested, although broader procurement, regulatory approval, and manufacturing scaling would be required for widespread deployment.
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Importance: With the high burden of hypertension in sub-Saharan Africa, there is a need for effective, safe and scalable treatment strategies. Objective: To compare, among Black African adults, the effectiveness and safety of a novel low-dose triple-pill protocol compared with a standard-care protocol for blood pressure lowering. Design and Setting: Randomized, parallel-group, open-label, multicenter trial conducted in public hospital-based family medicine clinics in Nigeria. Participants: Black African adults with uncontrolled hypertension (≥140/90 mm Hg) who were untreated or receiving a single blood pressure-lowering drug. Interventions: Participants were randomly allocated to low-dose triple-pill or standard-care protocols. The 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. The standard-care protocol was the Nigeria hypertension treatment protocol starting with amlodipine (5 mg). Main Outcomes and Measures: The 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: The first participant was randomized on July 19, 2022, and the last follow-up visit was on July 18, 2024. Among 300 randomized participants (54% female; mean age, 52 years; baseline mean home blood pressure, 151/97 mm Hg; and clinic blood pressure, 156/97 mm Hg), 273 (91%) completed the trial. At month 6, mean home systolic blood pressure was on average 31 mm Hg (95% CI, 28 to 33 mm Hg) lower in the triple-pill protocol group and 26 mm Hg (95% CI, 22 to 28 mm Hg) lower in the standard-care protocol group (adjusted difference, -5.8 mm Hg [95% CI, -8.0 to -3.6]; P < .001]). 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. Conclusions and Relevance: Among Black African adults with uncontrolled hypertension, a low-dose triple-pill protocol achieved better blood pressure lowering and control with good tolerability compared with the standard-care protocol. Trial Registration: Pan African Clinical Trials Registry Identifier: PACTR202107579572114.
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DOI: 10.1001/jama.2024.18080
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