In the EMPA-KIDNEY trial of patients with chronic kidney disease (CKD), empagliflozin produced a lower risk of progression of kidney disease or death from cardiovascular causes than placebo, researchers report. “Treatment with empagliflozin was effective regardless of diabetes status and was effective in patients with a broad range of eGFRs, down to approximately 20 mL per minute per 1.73 m2,” the authors conclude. “The risk of hospitalization for any cause was 14% lower in the empagliflozin group than in the placebo group.”
A total of 6,609 patients with eGFRs of 20–45 or 45–90 mL per minute per 1.73 m2 were randomized to empagliflozin 10 mg once daily or placebo. Based on a primary outcome of a composite of progression of kidney disease or death from cardiovascular causes,” the study shows: “During a median of 2.0 years of follow-up, progression of kidney disease or death from cardiovascular causes occurred in 432 of 3,304 patients (13.1%) in the empagliflozin group and in 558 of 3,305 patients (16.9%) in the placebo group (hazard ratio, 0.72; 95% confidence interval [CI], 0.64 to 0.82; P <0.001). Results were consistent among patients with or without diabetes and across subgroups defined according to eGFR ranges. The rate of hospitalization from any cause was lower in the empagliflozin group than in the placebo group (hazard ratio, 0.86; 95% CI, 0.78 to 0.95; P = 0.003), but there were no significant between-group differences with respect to the composite outcome of hospitalization for heart failure or death from cardiovascular causes (which occurred in 4.0% in the empagliflozin group and 4.6% in the placebo group) or death from any cause (in 4.5% and 5.1%, respectively). The rates of serious adverse events were similar in the two groups.”
Editorial: “The EMPA-KIDNEY trial adds to the evidence that SGLT2 inhibitors reduce the risk of progression of CKD or death from cardiovascular disease when added to [renin–angiotensin system] blockade,” editorialists write. “Furthermore, the safety profile of SGLT2 inhibitors is reassuring after almost a decade of clinical use. Analysis of the effects of SGLT2 inhibitors on CKD progression on the basis of both eGFR and albuminuria may provide more nuanced guidance for treatment. Longer follow-up to show reductions in the risk of ESKD and death would engender additional confidence. Finally, improved understanding of the mechanisms of renoprotection will further enable clinicians to prescribe the right drug at the right time to the right patient.”