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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