Table 2. Clinical Outcomes with the Polypill or Placebo.
| Outcomes | Polypill (N = 2861) |
Placebo (N = 2852) |
Hazard Ratio (95% CI)* |
|---|---|---|---|
| Primary outcome | |||
| Death from cardiovascular causes, myocardial infarction, stroke, heart failure, resuscitated cardiac arrest, or arterial revascularization — no. (%) | 126 (4.4) | 157 (5.5) | 0.79 (0.63–1.00) |
| Secondary outcomes | |||
| Death from cardiovascular causes, myocardial infarction, or stroke — no. (%) | 111 (3.9) | 139 (4.9) | 0.79 (0.61–1.01) |
| Death from cardiovascular causes, myocardial infarction, stroke, heart failure, resuscitated cardiac arrest, arterial revascularization, or angina with evidence of ischemia — no. (%) | 132 (4.6) | 164 (5.8) | 0.79 (0.63–1.00) |
| Components of the primary and secondary outcomes | |||
| Death from cardiovascular causes — no. (%)† | 84 (2.9) | 101 (3.5) | 0.82 (0.61–1.09) |
| Myocardial infarction — no. (%) | 17 (0.6) | 26 (0.9) | 0.66 (0.36–1.22) |
| Stroke — no. (%) | 26 (0.9) | 36 (1.3) | 0.71 (0.43–1.18) |
| Heart failure — no. (%) | 12 (0.4) | 10 (0.4) | 1.19 (0.51–2.74) |
| Resuscitated cardiac arrest — no. (%) | 1(<0.1) | 0 | — |
| Arterial revascularization — no. (%) | 12 (0.4) | 25 (0.9) | 0.48 (0.24–0.95) |
| Angina with evidence of ischemia — no. (%) | 17 (0.6) | 22 (0.8) | 0.77 (0.41–1.44) |
| Other efficacy outcomes | |||
| Death from any cause — no. (%) | 149 (5.2) | 163 (5.7) | 0.90 (0.72–1.13) |
| First and recurrent events of the primary outcome | |||
| No. of participants with ≥1 event | 126 | 157 | — |
| No. of participants with ≥2 events | 12 | 22 | — |
| Total no. of events | 138 | 179 | 0.76 (0.60–0.97)‡ |
*
The widths of the confidence intervals have not been adjusted for multiplicity, so the intervals should not be used to infer definitive treat ment effects.
†
Death from cardiovascular causes included confirmed death from cardiovascular causes (in 57 participants in the polypill group and in 80 in the placebo group) and death from an unknown cause, which was categorized according to the protocol definition as presumed death from cardiovascular causes (in 27 and 21 participants, respectively).
‡
The analysis was conducted with the use of a proportional-means model.