Treatment Strategies to Control Blood Pressure in People With Hypertension in Tanzania and Lesotho: A Randomized Clinical Trial.
Summary
In 1,268 adults with untreated hypertension in Lesotho and Tanzania, initiating low-dose dual therapy (amlodipine 5 mg + losartan 50 mg) was noninferior to stepped monotherapy for achieving target blood pressure at 12 weeks. Low-dose triple therapy did not significantly outperform monotherapy, and wide confidence intervals suggest uncertainty regarding small effect sizes.
Key Findings
- At 12 weeks, 56% (2-pill) vs 51% (stepped monotherapy) reached BP targets; noninferiority met (aOR 1.18; 95% CI 0.87–1.61).
- Low-dose triple therapy: 57% achieved target vs 49% with stepped monotherapy; not statistically superior (aOR 1.28; 95% CI 0.91–1.79).
- Findings support WHO guidance to start dual therapy and highlight uncertainty (wide CIs) regarding added benefits of triple therapy.
Clinical Implications
Initiating low-dose dual therapy is a viable and noninferior approach for first-line treatment in uncomplicated hypertension in resource-limited settings; triple therapy may be reserved until further evidence clarifies benefits. Implementation should consider medication access and follow-up capacity.
Why It Matters
This pragmatic RCT directly informs first-line antihypertensive strategies in African settings, supporting WHO guidance for early dual therapy while tempering expectations for immediate benefits of triple therapy.
Limitations
- Open-label design and short 12-week follow-up limit detection of long-term differences.
- Wide confidence intervals preclude ruling out clinically meaningful effects of additional pills.
Future Directions
Longer-term, larger-scale trials in diverse LMIC settings should evaluate sustained BP control, adherence, safety, and hard outcomes, and assess cost-effectiveness of dual vs triple therapy initiation.
Study Information
- Study Type
- RCT
- Research Domain
- Treatment
- Evidence Level
- I - Randomized clinical trial with predefined noninferiority and superiority analyses.
- Study Design
- OTHER