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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
EndpointRenal functionPlaceboAlogliptinHR (95% CI)Interactionpvalue
  PrimaryeGFR ≥ 60192 (9.8%)157 (7.9%)0.81 (0.65–0.99)0.014
eGFR < 60124 (17.3%)148 (20.6%)1.20 (0.95–1.53)
  SecondaryeGFR ≥ 60226 (11.5%)189 (9.5%)0.82 (0.68–0.99)0.021
eGFR < 60133 (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 endpointRenal functionPlaceboAlogliptinHR (95% CI)Interactionpvalue
  CV deatheGFR ≥ 6060 (3.1%)37 (1.9%)0.61 (0.41–0.92)0.079
eGFR < 6051 (7.1%)52 (7.2%)1.01 (0.69–1.48)
  Non-fatal MI*eGFR ≥ 60113 (5.8%)99 (5%)0.86 (0.66–1.13)0.013
eGFR < 6060 (8.4%)88 (12.3%)1.48 (1.07–2.06)
  Non-fatal strokeeGFR ≥ 6019 (1%)21 (1.1%)1.20 (0.95–1.53)0.28
eGFR < 6013 (1.8%)8 (1.1%)0.61 (0.25–1.47)
Other endpointsRenal functionPlaceboAlogliptinHR (95% CI)Interactionpvalue
  All-cause deatheGFR ≥ 6089 (4.5%)74 (3.7%)0.82 (0.60–1.12)0.56
eGFR < 6084 (11.7%)79 (11.0%)0.93 (0.68–1.27)
  All CV deathseGFR ≥ 6072 (3.7%)44 (2.2%)0.61 (0.42–0.88)0.013
eGFR < 6058 (8.1%)68 (9.5%)1.16 (0.82–1.65)
  HF hospitalizationseGFR ≥ 6043 (2.2%)44 (2.2%)1.01 (0.67–1.55)0.32
eGFR < 6046 (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