Oral Presentation Australian Diabetes Society and the Australian Diabetes Educators Association Annual Scientific Meeting 2016

Effect of Empagliflozin on Nephropathy in Subgroups by Age: Results from EMPA-REG OUTCOME (#33)

Richard M Bergenstal 1 , Paolo Calabro 2 , Mario Maldonado-Lutomirsky 3 , Maximilian von Eynatten 3 , Michaela Mattheus 3 , John Lachin 4 , Christoph Wanner 5 , Michael d'Emden 6
  1. International Diabetes Center at Park Nicollet, Minneapolis, USA
  2. U.O.C. di Cardiologia Second University of Naples, Monaldi Hospital, Naples, Italy
  3. Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany
  4. The Biostatistics Center, The George Washington University Biostatistics Center, Rockville, MD, USA
  5. Department of Medicine, Division of Nephrology, Würzburg University Clinic, Würzburg, Germany
  6. Royal Brisbane Hospital, Herston, QLD, Australia

Introduction: In the EMPA-REG OUTCOME trial, empagliflozin (EMPA) given in addition to standard of care significantly reduced the risk of new or worsening nephropathy versus placebo (PBO) in patients with type 2 diabetes (T2DM) and high CV risk.

Objective: We investigated the effect of age on the reduction in new or worsening nephropathy with EMPA.

Methods: Patients in EMPA-REG OUTCOME were randomized to receive EMPA 10 mg, EMPA 25 mg, or PBO. New or worsening nephropathy (defined as new onset of macroalbuminuria, doubling of serum creatinine, initiation of renal replacement therapy, or death due to renal disease) was analyzed in the pooled EMPA group vs PBO in subgroups by baseline age (<65, 65 to <75, ≥75 years).

Results: A total of 7020 patients were treated. Median observation time was 3.1 years. At baseline, mean (SD) age was 63.1 (8.6) years and 63.2 (8.8) years in the EMPA and PBO groups, respectively, and mean (SD) HbA1c was 8.07 (0.85) % and 8.08 (0.84) % in the EMPA and PBO groups, respectively. The benefit of EMPA vs PBO on new or worsening nephropathy was consistent across age categories (Figure). Across age subgroups, reported adverse events were consistent with the known safety profile of EMPA.

Conclusion: EMPA, in addition to standard of care, reduced the risk of new or worsening nephropathy in patients with T2DM and high CV risk irrespective of age.