Table 2. Primary and Secondary Outcomes.
| No./Total (%)a | Treatment Effect (95% CI) | P Valueb | ||
|---|---|---|---|---|
| Triple
Combination Pill Therapy (n = 349) |
Usual
Care (n = 351) |
|||
| Primary Outcome | ||||
| Achieving blood pressure target at 6 moc | 221/318 (69.5) | 182/329 (55.3) | RR, 1.23 (1.09 to 1.39)d | <.001 |
| Secondary Outcomes | ||||
| Achieving blood pressure target at 6 wkc | 223/329 (67.8) | 150/344 (43.6) | RR, 1.53 (1.33 to 1.76)d | <.001 |
| Achieving blood pressure target at 12 wkc | 239/329 (72.6) | 161/340 (47.4) | RR, 1.51 (1.32 to 1.72)d | <.001 |
| Change in systolic blood pressure at 6 mo, mm Hg | ||||
| Adjusted mean (95% CI) | −29.1 (−31.4 to −26.8) | −20.3 (−22.6 to −18.0) | MD, −8.8 (−11.2 to −6.4)e | <.001 |
| Crude mean (SD) | −29.3 (18.4) | −20.6 (16.8) | ||
| Change in diastolic blood pressure at 6 mo, mm Hg | ||||
| Adjusted mean (95% CI) | −13.9 (−15.3 to −12.4) | −9.3 (−10.7 to −7.9) | MD, −4.6 (−6.0 to −3.1)e | <.001 |
| Crude mean (SD) | −13.7 (12.1) | −9.5 (10.3) | ||
| Blood pressure–lowering medication | ||||
| Self-reported use at 6 mof | 305/321 (95.0) | 318/336 (94.6) | RR, 1.00 (0.97 to 1.04)d | .82 |
| Withdrawal due to adverse event during follow-up | 23/349 (6.6) | 24/351 (6.8) | RR, 0.97 (0.56 to 1.70)d | .92 |
Abbreviations: MD, mean difference; RR, relative risk.
Unless otherwise indicated.
Holm-Bonferroni adjustment23 for multiple comparisons did not alter the statistical significance of any of the secondary outcomes.
Defined as achieving systolic/diastolic blood pressure of less than 130/80 mm Hg for patients with diabetes or chronic kidney disease and less than 140/90 mm Hg for all other patients.
The treatment effect was estimated from a log-binomial model that included treatment group and use of blood pressure–lowering therapy at baseline as fixed effects and trial center as a random effect.
The treatment effect was estimated from an analysis of covariance including baseline blood pressure, treatment group, and use of blood pressure–lowering therapy at baseline as fixed effects and trial site as a random effect.
Defined as ingestion on at least 4 of the last 7 days. In the triple combination pill therapy group, all prescribed blood pressure–lowering medications includes the triple combination pill and any other blood pressure medication prescribed in addition to or instead of the triple combination pill.