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Table 3 Safety endpoints

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

Adverse eventsPlaceboAlogliptinp valueInter. p
eGFR ≥ 60 stratum
 Any serious adverse event607 (30.9%)564 (28.4%)0.0880.42
 Serious hypoglycemia4 (0.2%)9 (0.5%)0.170.14
 Any adverse event1490 (75.9%)1532 (77.3%)0.320.95
 Any hypoglycemia91 (4.6%)120 (6.1%)0.0480.007
Pancreatitis   0.36
 Acute5 (0.3%)5 (0.3%)0.99 
 Chronic4 (0.2%)2 (0.1%)0.41 
Angioedema6 (0.3%)7 (0.4%)0.800.78
Malignancy30 (1.5%)38 (1.9%)0.350.28
Dialysis3 (0.2%)1 (0.1%)0.310.27
Serum aminotransferases > 3× upper limit of normal at any time during trial   0.11
 Alanine aminotransferase37 (1.9%)43 (2.2%)0.53 
 Aspartate aminotransferase32 (1.6%)27 (1.4%)0.49 
eGFR < 60 stratum
 Any serious adverse event345 (48.2%)343 (47.8%)0.880.42
 Serious hypoglycemia12 (1.7%)9 (1.3%)0.510.14
 Any adverse event621 (86.7%)628 (87.5%)0.680.95
 Any hypoglycemia82 (11.5%)61 (8.5%)0.0620.007
Pancreatitis   0.36
 Acute3 (0.4%)7 (1.0%)0.21 
 Chronic03 (0.4%)0.083 
 Angioedema7 (1.0%)10 (1.4%)0.450.78
 Malignancy21 (2.9%)17 (2.4%)0.510.28
 Dialysis19 (2.7%)23 (3.2%)0.540.27
Serum aminotransferases > 3× upper limit of normal at any time during trial   0.11
 Alanine aminotransferase9 (1.3%)21 (2.9%)0.027 
 Aspartate aminotransferase11 (1.5%)21 (2.9%)0.075 
  1. p values were calculated by Fisher’s exact test with no adjustment for multiple comparisons. Hypoglycemia was reported by site investigators. The upper limit of normal for the alanine aminotransferase was25 U/L and for aspartate aminotransferase was 22 U/L
  2. eGFR estimated glomerular filtration rate in ml/min/1.73 m2, Inter. p p value for interaction between eGFR strata and treatment allocation for each outcome in a logistic regression model