Table 5.
Observations for oral semaglutide 14 mg once daily in the PIONEER 6 cardiovascular outcomes trial [51]
| Outcomea | Oral semaglutide (14 mg) (N = 1591) | Placebo (N = 1592) | Hazard ratio (95% CI) | ||
|---|---|---|---|---|---|
| No. (%) | No./100 person-yr | No. (%) | No./100 person-yr | ||
| Primary (MACE) outcomeb | 61 (3.8) | 2.9 | 76 (4.8) | 3.7 | 0.79 (0.57−1.11)c |
| Expanded (MACE) outcomed | 83 (5.2) | 4.0 | 100 (6.3) | 4.9 | 0.82 (0.61−1.10) |
| Death from any cause, nonfatal MI, or nonfatal stroke | 69 (4.3) | 3.3 | 89 (5.6) | 4.4 | 0.77 (0.56−1.05) |
| Death from any cause | 23 (1.4) | 1.1 | 45 (2.8) | 2.2 | 0.51 (0.31−0.84) |
| Death from CV causes | 15 (0.9) | 0.7 | 30 (1.9) | 1.4 | 0.49 (0.27−0.92) |
| Nonfatal MI | 37 (2.3) | 1.8 | 31 (1.9) | 1.5 | 1.18 (0.73−1.90) |
| Nonfatal stroke | 12 (0.8) | 0.6 | 16 (1.0) | 0.8 | 0.74 (0.35−1.57) |
| Unstable angina resulting in hospitalization | 11 (0.7) | 0.5 | 7 (0.4) | 0.3 | 1.56 (0.60−4.01) |
| Heart failure resulting in hospitalization | 21 (1.3) | 1.0 | 24 (1.5) | 1.2 | 0.86 (0.48−1.55) |
CI confidence interval, CV cardiovascular, MACE major adverse cardiovascular event, MI myocardial infarction
aOutcomes are first events that were positively adjudicated by the external adjudication committee. Data are for the full analysis set during the in-trial observation period (from randomization to the final follow-up visit). Deaths from CV causes included deaths for which the cause was undetermined.
bThe primary outcome was a composite of death from CV causes, nonfatal MI, or nonfatal stroke
cp < 0.001 for noninferiority, p = 0.17 for superiority. The primary outcome analysis was controlled for multiple comparisons. CIs for other analyses have not been adjusted for multiple comparisons
dThe expanded composite outcome consisted of death from CV causes, nonfatal MI, nonfatal stroke, unstable angina resulting in hospitalization, or heart failure resulting in hospitalization