248-OR: Empagliflozin and Cardiorenal Outcomes in Patients with Nonproteinuric Kidney Disease in the EMPA-REG OUTCOME Trial

Abstract

Proteinuria in chronic kidney disease (CKD) is a strong risk predictor for adverse cardiorenal outcomes. However, non-proteinuric CKD in type 2 diabetes (T2D) is rarely studied in clinical trials despite epidemiological evidence indicating a recent shift towards this phenotype. We explored the effect of empagliflozin (EMPA) on cardiorenal outcomes in a subgroup of patients from EMPA-REG OUTCOME with non-proteinuric CKD at baseline. 7020 patients with T2D and prior CV disease were treated with EMPA 25mg, 10mg or placebo (PBO) (median follow-up of 3.1 years). Post hoc, Cox regression assessed effects of EMPA vs. PBO on the composite outcome of CV death/HHF, CV death, HHF, a composite kidney outcome of incident/worsening nephropathy and all-cause mortality. Non-proteinuric CKD was defined as low eGFR and absence of overt albuminuria (eGFR <60 ml/min/1.73m2 and UACR <300 mg/g). Overall, 1290 (18.4%) met this criterion. In this exploratory analysis, beneficial effects of EMPA vs. PBO on cardiorenal outcomes were consistent in patients with T2D and non-proteinuric CKD as compared to all other patients. This result suggests that absence of overt proteinuria may not alter the cardiorenal treatment response to EMPA. The ongoing EMPA-KIDNEY study investigates effects of EMPA on cardiorenal outcomes in a broad CKD population with and w/o diabetes including patients with lower proteinuria levels. Disclosure S.E. Inzucchi: Consultant; Self; vTv Therapeutics, Zafgen, Inc. Other Relationship; Self; AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Lexicon Pharmaceuticals, Inc., Novo Nordisk A/S, Sanofi. B. Zinman: Advisory Panel; Self; Abbott, AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, Janssen Pharmaceuticals, Inc., Merck & Co., Inc., Novo Nordisk Inc. Consultant; Self; Abbott, AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, Janssen Pharmaceuticals, Inc., Merck & Co., Inc., Novo Nordisk Inc. J. George: Employee; Self; Boehringer Ingelheim International GmbH. M. Mattheus: Employee; Self; Boehringer Ingelheim Pharma GmbH&Co.KG. M. von Eynatten: Employee; Self; Boehringer Ingelheim International GmbH. C. Wanner: Advisory Panel; Self; Bayer AG, Boehringer Ingelheim International GmbH, Merck Sharp & Dohme Corp. Board Member; Self; Boehringer Ingelheim International GmbH. Speaker's Bureau; Self; AstraZeneca, Boehringer Ingelheim International GmbH, Lilly Diabetes, Mitsubishi Tanabe Pharma Corporation. S. Hauske: Employee; Self; Boehringer Ingelheim International GmbH. Funding Boehringer Ingelheim; Eli Lilly and Company