Table 1.
Baseline characteristics and renal outcomes in CVOT with GLP-1RA
| ELIXA | LEADER | SUSTAIN-6 | EXSCEL | REWIND | AMPLITUDE-O | |
|---|---|---|---|---|---|---|
| N | 6068 | 9340 | 3297 | 14752 | 9463 | 4076 |
| Median follow-up (yrs) | 2.1 | 3.8 | 2.1 | 3.2 | 5.4 | 1.8 |
| Mean age (yrs) | 60.2 | 64.3 | 64.6 | 62.0 | 66.2 | 64.5 |
| Female (%) | 30.6 | 35.7 | 39.3 | 38.0 | 46.3 | 33 |
| Mean diabetes duration (yrs) | 9.3 | 12.8 | 13.9 | 12 | 10 | 15.4 |
| Mean HbA1c (%) | 7.6 | 8.7 | 8.7 | 8.0 | 7.3 | 8.9 |
| Mean eGFR (ml/min/1.73 m2) | 75.9 | 80.4 | 76.1 | 76.3 | 76.9 | 72.48 |
| eGFR <60 ml/min/1.73 m2 (%) | 23.2 | 21.7 | 28.5 | 21.7 | 22.2 | 31.6 |
| Median UACR (mg/g) | 10.5 | - | - | 14.1 | 16.28 | 28.3 |
| UACR category (%) | ||||||
| <30 mg/g | – | 63.4 | 59.7 | – | 64.9 | – |
| 30–300 mg/g | – | 26.3 | 27.3 | – | 27.5 | 48.5 (>30) |
| >300 mg/g | – | 10.3 | 12.9 | – | 8.0 | – |
| Main renal composite outcome | ||||||
| Definition | new-onset MA | new-onset MA; persistent doubling of sCr (eGFR < 45 ml/min/1.73 m2); renal-replacement therapy; renal death | new-onset MA; persistent doubling of sCr (eGFR < 45 ml/min/1.73 m2); continuous renal-replacement therapy; renal death | new-onset MA; ≥40% eGFR decrease; renal-replacement therapy; renal death | new-onset MA; ≥30% eGFR decrease; renal-replacement therapy | new-onset MA with ≥30% UACR increase; ≥40% eGFR decrease for ≥30 days; renal transplant or renal-replacement therapy for ≥90 days; eGFR < 15 ml/min/1.73 m2 for ≥30 days |
| HR (95% CI) | 0.84 (0.68–1.02) | 0.78 (0.67–0.92) | 0.64 (0.46–0.88) | 0.88(0.76–1.01) | 0.85 (0.77–0.93) | 0.68 (0.57–0.79) |
| Secondary renal outcomes | ||||||
| Worsening kidney functiona (HR (95% CI)) | 1.16 (0.74–1.83) | 0.89 (0.67–1.19) | 1.28 (0.64–2.58) | 0.88 (0.74–1.05) | 0.70 (0.57–0.85) | 0.77 (0.57–1.02) |
| New-onset MA (HR (95% CI)) | 0.84 (0.74–1.02) | 0.74 (0.74–0.91) | 0.54 (0.37–0.77) | 143/6456 vs. 173/6458b | 0.77 (0.68–0.87) | 0.68 (0.58–0.80) |
| Renal-replacement therapy | 3/2702 vs. 7/2793b | 0.87 (0.61–1.24) | 0.91 (0.40–2.07) | 55/7344 vs. 65/7389b | 0.75 (0.39–1.44) | – |
| Renal death | – | 1.59 (0.52–4.87) | – | 5/7356 vs. 5/7396b | – | – |
eGFR estimated glomerular filtration rate, MA macroalbuminuria, UACR urinary albumin:creatinine ratio
aDefined as either doubling of serum creatinine or ≥40% decline in eGFR (except for EXSCEL, in which kidney replacement therapy or renal death were included);
bno HR reported