Consistent Effects of Empagliflozin on Cardiovascular and Kidney Outcomes Irrespective of Diabetic Kidney Disease Categories - Insights from the EMPA-REG OUTCOME trial.

Aims Diabetes is the leading cause of kidney failure. Additionally, elevated albuminuria predicts increased cardio/kidney risk. Recent evidence shows a shift toward non-albuminuric phenotypes of diabetic kidney disease (DKD; i.e., reduced glomerular filtration rate [GFR] without overt albuminuria). Interventions that could lower cardio/kidney risk in patients with DKD across the albuminuria spectrum are needed. Materials and methods EMPA-REG OUTCOME randomized participants (1:1:1) to empagliflozin 10mg, 25mg or placebo, added to standard of care. Post hoc, patients with different clinical phenotypes of DKD at baseline were categorized in three subgroups: 1) overt DKD (overt albuminuria [UACR >300 mg/g] with any eGFR; n = 769); 2) non-overt DKD (kidney impairment [eGFR Results Empagliflozin significantly reduced risk of CV and kidney outcomes across all subgroups (P-values for interaction >0.05), consistent with the overall trial population findings. Empagliflozin also significantly reduced the yearly loss of eGFR, assessed by chronic slopes, in all subgroups. The adverse event profile of empagliflozin was similar across all subgroups. Conclusions Empagliflozin may improve CV and kidney outcomes and slow progression of kidney disease in type 2 diabetes patients with DKD, irrespective of its clinical form, both with or without the presence of overt albuminuria. This article is protected by copyright. All rights reserved.