Table 2.

Event rates according to baseline biomarkers and change in biomarker from 0 to 6 mo in participants of the Examination of Cardiovascular Outcomes with Alogliptin versus Standard of Care (EXAMINE) trial

VariableCystatin C BaselineuKIM-1–to-Creatinine BaselineuNGAL-to-Creatinine BaselineChange in uKIM-1­–to-CreatinineaChange in uNGAL-to-Creatininea
Decline in eGFRb
 Q10.2% (2 of 1270)0.6% (7 of 1199)0.6% (7 of 1249)1.5% (16 of 1050)2.8% (30 of 1066)
 Q20.2% (3 of 1310)1.4% (17 of 1232)0.9% (11 of 1236)1.1% (11 of 10,385)0.4% (4 of 1049)
 Q30.9% (12 of 1334)1.5% (18 of 1216)1.4% (17 of 1233)1.3% (14 of 1058)0.8% (9 of 1079)
 Q46.0% (78 of 1290)3.7% (45 of 1222)4.4% (54 of 1237)1.6% (17 of 1050)1.4% (15 of 1066)
P Q1 versus Q4<0.001<0.001<0.0010.860.02
P trend<0.001<0.001<0.0010.740.02
30% decline in eGFR, ml/min per 1.73 m2/1.73 m2
 Q11.2% (15 of 1272)1.7% (20 of 1199)1.5% (19 of 1250)5.1% (54 of 1050)6.9% (74 of 1066)
 Q21.5% (19 of 1313)4.6% (56 of 1232)2.7% (33 of 1237)3.9% (40 of 1039)2.7% (28 of 1049)
 Q34.9% (66 of 1337)5.0% (61 of 1216)4.3% (53 of 1237)3.7% (39 of 1061)3.3% (36 of 1082)
 Q410.3% (133 of 1291)8.0% (98 of 1222)8.8% (109 of 1238)6.1% (64 of 1050)5.6% (60 of 1068)
P Q1 versus Q4<0.001<0.001<0.0010.340.21
P trend<0.001<0.001<0.0010.360.24
New-onset microalbuminuriac
 Q132.2% (68 of 211)34.0% (82 of 241)29.7% (71 of 239)48.5% (100 of 206)46.6% (76 of 163)
 Q229.1% (68 of 234)27.0% (65 of 241)32.7% (72 of 220)32.7% (51 of 156)35.2% (70 of 199)
 Q337.7% (93 of 247)38.9% (72 of 185)37.1% (85 of 229)31.5% (57 of 181)27.9% (58 of 208)
 Q439.0% (69 of 177)41.6% (69 of 166)42.6% (66 of 155)25.5% (42 of 165)33.6% (49 of 146)
P Q1 versus Q40.170.120.01<0.0010.02
P trend0.050.030.01<0.0010.004
New-onset macroalbuminuriad
 Q17.9% (33 of 418)13.1% (58 of 444)13.2% (56 of 423)18.8% (82 of 436)23.3% (96 of 412)
 Q28.0% (36 of 448)13.5% (67 of 496)11.0 (52 of 473)16.6% (62 of 374)11.9% (48 of 403)
 Q313.0% (72 of 554)13.6% (63 of 462)110% (55 of 500)10.0% (39 of 391)8.2% (33 of 403)
 Q422.2% (116 of 522)12.4% (58 of 469)17.5% (85 of 487)11.6% (47 of 405)13.2% (53 of 402)
P Q1 versus Q4<0.0010.750.080.004<0.001
P trend<0.0010.770.06<0.001<0.001
  • uKIM-1, urinary kidney injury molecule–1; uNGAL, urinary neutrophil gelatinase-associated lipocalin; Q, quartile.

  • a Subjects with eGFR decline that occurred within 180 d (6 mo) are excluded for the calculations of biomarker change over 6 mo (n=32). No subjects are excluded for the baseline calculations.

  • b eGFR decline was defined as 50% decrease in eGFR from baseline or ESRD with stage 5 CKD eGFR<15 ml/min per 1.73 m2 dialysis, or both.

  • c Incident microalbuminuria, >30–300 mg/g albumin-to-creatinine.

  • d Incident macroalbuminuria, ≥300 mg/g albumin-to-creatinine. Urine albumin-to-creatinine ratio (mg/g) was calculated as urine albumin (mg/dl)-to-urine creatinine (mg/dl)×1000.