The global prevalence of hypertension is expected to reach 1.5 billion people by 2025. Of these, 74.7 million affected individuals currently reside in sub-Saharan Africa, a figure projected to increase to 125.5 million by 2025.1. Therefore, there is a pressing need for effective, safe, and scalable treatment strategies.
This randomized, parallel-group, open-label, multi-centre trial conducted in Nigeria aimed to assess the effectiveness and safety of a novel low-dose triple-pill protocol compared to standard care for managing uncontrolled hypertension in Black African adults.
The trial included 300 participants with uncontrolled hypertension (≥140/90 mm Hg) who were either untreated or on a single anti-hypertensive medication. 54% of the group were female, with an average age of 52 years and a baseline home blood pressure of 151/97 mm Hg.
Participants were randomly assigned to one of two treatment protocols:
- Low-dose triple-pill protocol: This involved a combination of telmisartan, amlodipine, and indapamide in varying doses (10/1.25/0.625 mg, 20/2.5/1.25 mg, and 40/5/2.5 mg), with accelerated dose escalation.
- Standard-care protocol: Following Nigeria’s hypertension treatment guidelines, starting with 5 mg of amlodipine.
The primary outcome for effectiveness was the reduction in home mean systolic blood pressure, and the primary safety outcome was discontinuation of treatment due to adverse events, measured over six months.
The following findings were recorded:
Of the 300 participants, 273 (91%) completed the trial.
- By month 6, the mean home systolic blood pressure in the triple-pill group had decreased by an average of 31 mm Hg, while the standard-care group saw a reduction of 26 mm Hg (95% CI, 22 to 28 mm Hg), resulting in an adjusted difference of −5.8 mm Hg.
- 82% of the participants in the triple-pill group achieved clinic blood pressure control (<140/90 mm Hg) compared to 72% in the standard care group.
- 62% of those in the triple-pill group achieved home blood pressure control (<130/80 mm Hg) compared to 28% in the standard care group.
- Importantly, no participants discontinued treatment due to adverse events, indicating good tolerability for both protocols.
In conclusion, the low-dose triple-pill protocol was more effective in lowering and controlling blood pressure compared to the standard-care protocol, without compromising safety, among Black African adults with uncontrolled hypertension.
The trial was registered with the Pan African Clinical Trials Registry (PACTR20210757957211)
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