Table 3.
Cardiovascular endpoints in the ITT population; Treatment Period + all follow-up days
| Endpoint | Number of events (%) | Rate/100 patient-yearsa | Hazard ratio of omarigliptin vs. placebo (95% CI)b | ||
|---|---|---|---|---|---|
| Omarigliptin N = 2092 |
Placebo N = 2100 |
Omarigliptin | Placebo | ||
| Cardiovascular death, nonfatal myocardial infarction or nonfatal stroke | 114 (5.45) | 114 (5.43) | 2.96 | 2.97 | 1.00 (0.77, 1.29) |
| Cardiovascular-related death | 37 (1.77) | 35 (1.67) | 0.94 | 0.89 | 1.06 (0.66, 1.68) |
| Fatal and nonfatal myocardial infarction | 52 (2.49) | 60 (2.86) | 1.34 | 1.55 | 0.87 (0.60, 1.26) |
| Fatal and nonfatal stroke | 32 (1.53) | 34 (1.62) | 0.82 | 0.88 | 0.94 (0.58, 1.52) |
| All-cause mortality | 64 (3.06) | 50 (2.38) | 1.63 | 1.28 | 1.28 (0.88, 1.85) |
| Hospitalization for heart failure | 20 (0.96) | 33 (1.57) | 0.51 | 0.85 | 0.60 (0.35, 1.05) |
| Hospitalization for heart failure or CV death | 55 (2.63) | 64 (3.05) | 1.41 | 1.65 | 0.86 (0.60, 1.23) |
aPatient-years is calculated as the sum of all patients follow-up time to event. For patients without an event, the time to event is the last follow-up time as defined for ITT population in the statistical analysis plan
bBased on the proportional hazards model that includes treatment as an explanatory factor