Table 1.
Key cardiovascular safety and CKD trials of SGLT2i
| Drug | Trial | Trial type | CVD (% of patients) | eGFR (mL/min/1.73 m2) | UACR (mg/g)a | MACE HR (95% CI) | Stroke/AMI HR (95% CI) | CV death HR (95% CI) | Heart failure hospitalization HR (95% CI) | Renal outcome HR (95% CI) |
|---|---|---|---|---|---|---|---|---|---|---|
| Canagliflozin | CANVAS [6] | CV safety | 65.6 | 76.5 | 12.3 (6.65–42.1) | 0.86* (0.75–0.97) | Not different | 0.87 (0.72–1.06) | 0.67 (0.52–0.87) | 0.60b (0.47–0.77) |
| CREDENCE [7] | DKD | 50.4 | 56.2 | 927 (463–1833) | 0.80 (0.55–1.00) | Not different | 0.78 (0.55–1.00) | 0.61 (0.47–0.80) | 0.68c (0.54–0.86) | |
| Dapagliflozin | DECLARE-TIMI [8] | CV safety | 40.6 | 85.2 | Not available | 0.93 (0.84–1.03) | Not different | 0.98 (0.82–1.17) | 0.73 (0.61–0.88) | 0.53d (0.43–0.66) |
| Empagliflozin | EMPA-REG OUTCOME [5, 15] | CV safety | 99.1 | 74 | Not availablee | 0.86* (0.74–0.99) | Not different | 0.62 (0.49–0.77) | 0.65 (0.50–0.85) | 0.54f (0.40–0.75) |
AMI, acute myocardial infarction; MACE, composite of cardiovascular death, myocardial infarction or ischaemic stroke.
a
Median (interquartile range).
b
Composite of 40% reduction in eGFR, renal replacement therapy or renal death.
c
Dialysis for at least 30 days, kidney transplantation or eGFR < 15 mL/min/1.73 m2 for at least 30 days.
d
Composite of ≥40% reduction in eGFR to <60 mL/min/1.73 m2, end-stage kidney disease or death from renal cause.
e
UACR ≥ 30 mg/g in 40% of participants.
f
Doubling of serum creatinine with eGFR ≤ 45 mL/min/1.73 m2, initiation of renal replacement therapy or death from renal disease.
*
P < 0.05 for superiority.