HypertensionRandomised controlled trial

Treatment Strategies to Control Blood Pressure in People With Hypertension in Tanzania and Lesotho

JAMA CardiolPublished

  • Randomised controlled trial
  • open-label
  • parallel
  • 3-arm
  • non-inferiority (margin 10%) and superiority
  • 2 hospitals

Authors' conclusion

Results of this randomized clinical trial show that in 2 African settings, for adults with uncomplicated untreated hypertension, a strategy starting a 2-pill low-dose treatment was noninferior to starting stepped monotherapy. Two-pill and 3-pill low-dose strategies were not superior to stepped monotherapy.

Study context

Population
Nonpregnant Black African adults with uncomplicated, untreated hypertension, rural Lesotho and Tanzaniarandomized 2:2:1
Participants
1,268 adults
Comparison
2-pill or 3-pill low-dose strategy vs stepped monotherapy
  • Monotherapyn = 505reference
  • 2-pilln = 510
  • 3-pilln = 253
Primary endpoint
Proportion reaching target BP (≤130/80 mm Hg if <65 years; ≤140/90 mm Hg if ≥65 years)
Follow-up
12 weeks

Primary result

Target BP reached (non-inferiority analysis)

Adjusted odds ratio

1.18

95% CI 0.87–1.61

Events by treatment group

2-pill vs Monotherapy
aOR 1.18 (95% CI 0.87–1.61)

Non-inferiority margin 10 as printed, not drawn

As reported in the abstract

Further findings

OutcomeMonotherapy2-pill3-pillaOR (95% CI)P value
Target BP reached (superiority analysis, multiple imputation) · 12 weeks — 2-pill vs Monotherapy · multiple imputation for missing outcome data49%55%57%1.24 (0.94–1.63)P = 0.12
Target BP reached (superiority analysis, multiple imputation) · 12 weeks — 3-pill vs Monotherapy · multiple imputation for missing outcome data1.28 (0.91–1.79)P = 0.16

Original publication

Treatment Strategies to Control Blood Pressure in People With Hypertension in Tanzania and Lesotho. JAMA Cardiol. Published 1 April 2025. doi:10.1001/jamacardio.2024.5124

Summarised from the published abstract; every number is checked against it