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. 2022 Dec 19;10(12):3294. doi: 10.3390/biomedicines10123294

Table 2.

Summary of trials of empagliflozin in patients with T2DM and CKD [18,44,49,51].

Authors Wanner et al., 2016 [44] Barnett et al., 2014 [51] Cherney et al., 2016 [49] Zannad et al., 2021 [18]
Study design randomised, double-blind, placebo-controlled trial in patients with DM type 2, established CV disease and eGFR at least 30 mL/min/1.73 m2 randomised, double-blind, parallel group, placebo-controlled trial in patients with 2, 3 or 4 stage of CKD and HbA1C 7–10% pooled analysis of patients with CKD and DM type 2 from phase III of clinical trials randomised, double-blind, placebo-controlled, parallel-group, event-driven trial
All patients 7020 741 851 3730
Baseline renal function eGFR < 59 mL/min/1.73 m2 Group
1. Placebo
2. Empagliflozin		 eGFR > 60 mL/min/1.73 m2 Group
1. Placebo
2. Empagliflozin		 Patients with chronic kidney disease Stage 2 Stage 3 Stage 4 No of patients with
UACR 30–300 mg/g
Empagliflozin
388
Placebo
248
UACR > 300 mg/g
Empagliflozin 128
Placebo 87		 Patients with CKD:
eGFR < 60 mL/min/1.73 m2 or UACR > 300 mg/g without CKD:
eGFR ≥ 60 mL/min/1.73 m2 and UACR ≤ 300 mg/g
eGFR
1. 48.6 mL/min/1.73 m2
2. 48.4 mL/min/1.73 m2 		eGFR
1. 82.7 mL/min/1.73 m2
2. 83.1 mL/min/1.73 m2 		eGFR ≥ 60 mL/min/1.73 m2 < 90 mL/min/1.73 m2 eGFR ≥ 30 mL/min/1.73 m2 < 60 mL/min/1.73 m2 eGFR ≥ 15 mL/min/1.73 m2 < 30 mL/min/1.73 m2
No of patients with macro-/microalbuminuria 1. 115/488
2. 223/977		 No of patients with macro-/microalbuminuria 1. 145/1569
2. 286/3149		 290 patients 374 patients 74 patients
Duration 3.1 years 52 weeks 24 weeks 16 months
Treatment Empagliflozin 10 mg, 25 mg, Placebo In stage 2 of CKD Empagliflozin 10 mg, 25 mg, Placebo
In stage 3 and 4 of CKD Empagliflozin 25 mg, Placebo		 Empagliflozin 10 mg, 25 mg, Placebo Empagliflozin 10 mg, Placebo
Renal outcome Empagliflozin vs. placebo
Incident or worsening nephropathy (12.7% vs. 18.8%), progression to macroalbuminuria (11.2% vs. 16.2%), doubling of serum creatinine level (1.5% vs. 2.6%), initiation of RRT (0.3% vs. 0.6%), incident albuminuria (51.5% vs. 51.2%)		 Baseline to 52 week change of UACR empagliflozin vs. placebo
Stage 2 Empagliflozin 10 mg 184.59; Empagliflozin 25 mg 235.86
Stage 3 Empagliflozin 25 mg 183.78 Macroalbuminuria to microalbuminuria 32.6% vs. 8.6%;
Microalbuminuria to no albuminuria 27.5% vs. 21.4%		 Change in UACR from baseline to 24 week vs. placebo
30–300 mg/g
−32%, p < 0.001> 300 mg/g
−41%, p < 0.001		 Reduced slope of eGFR by 1.11 mL/min/1.73 m2/year (p < 0.013) in patients with CKD and 2.41 L/min/1.73 m2 (p < 0.001) in patients without CKD; composite renal outcome in patients with CKD HR = 0.53 and without CKD HR = 0.46

DM, diabetes mellitus; CKD, chronic kidney disease; eGFR, estimated glomerular filtration rate; RRT, renal replacement therapy; HbA1C, glycated hemoglobinA1C; UACR, urinary albumin-to-creatinine ratio; HR, hazard ratio.