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Table 2 Study endpoints by renal function strata

From: Alogliptin after acute coronary syndrome in patients with type 2 diabetes: a renal function stratified analysis of the EXAMINE trial

(A) Primary and secondary endpoints by renal function strata

Endpoint

Renal function

Placebo

Alogliptin

HR (95% CI)

Interactionpvalue

  Primary

eGFR ≥ 60

192 (9.8%)

157 (7.9%)

0.81 (0.65–0.99)

0.014

eGFR < 60

124 (17.3%)

148 (20.6%)

1.20 (0.95–1.53)

  Secondary

eGFR ≥ 60

226 (11.5%)

189 (9.5%)

0.82 (0.68–0.99)

0.021

eGFR < 60

133 (18.6%)

155 (21.6%)

1.17 (0.93–1.47)

(B) Components of primary endpoint and other endpoints by renal function strata

Components of primary endpoint

Renal function

Placebo

Alogliptin

HR (95% CI)

Interactionpvalue

  CV death

eGFR ≥ 60

60 (3.1%)

37 (1.9%)

0.61 (0.41–0.92)

0.079

eGFR < 60

51 (7.1%)

52 (7.2%)

1.01 (0.69–1.48)

  Non-fatal MI*

eGFR ≥ 60

113 (5.8%)

99 (5%)

0.86 (0.66–1.13)

0.013

eGFR < 60

60 (8.4%)

88 (12.3%)

1.48 (1.07–2.06)

  Non-fatal stroke

eGFR ≥ 60

19 (1%)

21 (1.1%)

1.20 (0.95–1.53)

0.28

eGFR < 60

13 (1.8%)

8 (1.1%)

0.61 (0.25–1.47)

Other endpoints

Renal function

Placebo

Alogliptin

HR (95% CI)

Interactionpvalue

  All-cause death

eGFR ≥ 60

89 (4.5%)

74 (3.7%)

0.82 (0.60–1.12)

0.56

eGFR < 60

84 (11.7%)

79 (11.0%)

0.93 (0.68–1.27)

  All CV deaths

eGFR ≥ 60

72 (3.7%)

44 (2.2%)

0.61 (0.42–0.88)

0.013

eGFR < 60

58 (8.1%)

68 (9.5%)

1.16 (0.82–1.65)

  HF hospitalizations

eGFR ≥ 60

43 (2.2%)

44 (2.2%)

1.01 (0.67–1.55)

0.32

eGFR < 60

46 (6.4%)

62 (8.6%)

1.35 (0.92–1.97)

  1. The primary endpoint was a composite of cardiovascular death, non-fatal MI, and non-fatal stroke. The secondary endpoint was a composite of death from cardiovascular causes, nonfatal myocardial infarction, nonfatal stroke, or urgent revascularization due to unstable angina within 24 h after hospital admission
  2. MI myocardial infarction, CV cardiovascular, HF heart failure, eGFR estimated glomerular filtration rate in ml/min/1.73 m2
  3. *After adjustment for the competing risk of death, HR (95% CI) is 0.87 (0.66–1.14) for normal and 1.50 (1.08–2.08) for impaired renal function