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Empagliflozin and Kidney Function Decline in Patients with Type 2 Diabetes: A Slope Analysis from the EMPA-REG OUTCOME Trial

Background: Empagliflozin slowed the progression of CKD in patients with type 2 diabetes and cardiovascular disease in the EMPA-REG OUTCOME Trial. In a prespecified statistical approach, we assessed treatment differences in kidney function by analyzing slopes of eGFR changes. Methods: Participants (n=7020) were randomized (1:1:1) to empagliflozin 10 mg/d, empagliflozin 25 mg/d, or placebo added to standard of care. We calculated eGFR slopes using random- intercept/random-coefficient models for prespecified study periods: treatment initiation (baseline to week 4), chronic maintenance treatment (week 4 to last value on treatment), and post-treatment (last value on treatment to follow-up). Results: Compared with placebo, empagliflozin was associated with uniform shifts in individual eGFR slopes across all periods. On treatment initiation, adjusted mean slope (eGFR change per week, ml/min per 1.73 m2) decreased with empagliflozin (-0.77 ; 95% confidence interval, -0.83 to -0.71 ; placebo: 0.01 ; 95% confidence interval, -0.08 to 0.10 ; P<0.001). However, annual mean slope (ml/min per 1.73 m2 per year) did not decline with empagliflozin during chronic treatment (empagliflozin: 0.23 ; 95% confidence interval, 0.05 to 0.40 ; placebo: -1.46 ; 95% confidence interval, -1.74 to -1.17 ; P<0.001). After drug cessation, the adjusted mean eGFR slope (ml/min per 1.73 m2 per week) increased and mean eGFR returned toward baseline level only in the empagliflozin group (0.56 ; 95% confidence interval, 0.49 to 0.62 ; placebo -0.02 ; 95% confidence interval, -0.12 to 0.08 ; P<0.001). Results were consistent across patient subgroups at higher CKD risk. Conclusions: The hemodynamic effects of empagliflozin, associated with reduction in intraglomerular pressure, may contribute to long- term preservation of kidney function.

chronic kidney disease ; diabetes mellitus ; randomized controlled trials.

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