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Table 3 Cardiovascular endpoints in the ITT population; Treatment Period + all follow-up days

From: A randomized, placebo-controlled study of the cardiovascular safety of the once-weekly DPP-4 inhibitor omarigliptin in patients with type 2 diabetes mellitus

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)
  1. 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
  2. bBased on the proportional hazards model that includes treatment as an explanatory factor