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Table 3 Assumptions for sample size calculation

From: The coArtHA trial—identifying the most effective treatment strategies to control arterial hypertension in sub-Saharan Africa: study protocol for a randomized controlled trial

 

Dual combination Guideline + incremental value of ARB in African patients

Triple combination quarter dose for 3 widely available drugs used

Control

WHO standard of care starting with monotherapy

Literature

Reported response in 67% of Africans (response = diastolic blood pressure < 90 mmHg or 10% decrease [10, 52])

Reported response in 83% of patients* (response = blood pressure < 135/85 mmHg [17])

Reported response in 67% of patients in Nigeria (response = blood pressure < 149/90 mmHg [53])

Conservative effect estimation for higher target BP£

60%

75%

50%

Conservative effect estimation for lower target BP$

40%

55%

40%

Comparison with cited studies

Assumption of a smaller effect due to lower BP target

Effect might be lower (3 drugs instead of 4; no single pill)

Effect might be higher as allowance to increase dosage

Effect might be lower due to lower target

  1. ARB angiotensin receptor blocker, BP blood pressure, WHO World Health Organization
  2. £140/90 mmHg
  3. $130/80 mmHg