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Empagliflozin improves renal outcomes in patients with or without heart failure at baseline - insights from the EMPA-REG OUTCOME trial

Session Patient management - From oral treatment to transplant

Speaker Javed Butler

Congress : Heart Failure 2018

  • Topic : preventive cardiology
  • Sub-topic : Diabetes and the Heart
  • Session type : Rapid Fire Abstracts
  • FP Number : 1541

Authors : J Butler (Stony Brook,US), F Zannad (Nancy,FR), D Fitchett (Toronto,CA), B Zinman (Toronto,CA), A Koitka-Weber (Biberach,DE), M Von Eynatten (Ingelheim,DE), U Hehnke (Ingelheim,DE), J George (Ingelheim,DE), M Brueckmann (Ingelheim,DE), AK Cheung (Salt Lake City,US), C Wanner (Wuerzburg,DE)

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Authors:
J Butler1 , F Zannad2 , D Fitchett3 , B Zinman4 , A Koitka-Weber5 , M Von Eynatten6 , U Hehnke6 , J George6 , M Brueckmann6 , AK Cheung7 , C Wanner8 , 1Stony Brook University Medical Center, Medicine - Stony Brook - United States of America , 2Institut Lorrain du Coeur et des Vaisseaux - Nancy - France , 3St Michael's Hospital, University of Toronto - Toronto - Canada , 4Lunenfeld-Tanenbaum Research Institute, Mount Sinai Hospital, University of Toronto - Toronto - Canada , 5Boehringer Ingelheim Pharma GmbH & Co. KG - Biberach - Germany , 6Boehringer Ingelheim Pharma GmbH & Co. KG - Ingelheim - Germany , 7University of Utah - Salt Lake City - United States of America , 8Dept of Medicine, Wuerzburg University Clinic - Wuerzburg - Germany ,

Citation:

Background: Chronic kidney disease (CKD) is common and portends worse prognosis in patients with heart failure (HF), especially in the presence of type 2 diabetes (T2D). Since pathophysiologically, CKD and HF are linked, progression of CKD and its association with outcomes may not be similar among patients with or without HF. In the EMPA-REG OUTCOME trial (NCT01131676), the SGLT2 inhibitor, empagliflozin (EMPA) on a background of standard of care significantly reduced the risk of cardiovascular (CV) death by 38% vs placebo (PBO) in patients with T2D and established CV disease (CVD). Empagliflozin also reduced the risk of incident or worsening nephropathy by 39%, and slowed progression of CKD. Here, we report post-hoc kidney outcomes in patients with or without HF at baseline from the EMPA-REG OUTCOME trial.

Methods: Patients were randomized (1:1:1) to EMPA 10 mg, 25 mg or PBO. The composite kidney outcome of incident or worsening nephropathy, defined as progression to macroalbuminuria, doubling of serum creatinine, initiation of renal replacement therapy, or death from renal disease, was analyzed in patients with or without HF at baseline. The incidence of first sustained decline in eGFR from baseline of =40% was also evaluated. Cox proportional hazards models were used to investigate the consistency of treatment effect across subgroups.

Results: Of 7020 treated patients, 706 (10.1%) had HF at baseline. Overall, the incidence of kidney outcome events was numerically higher in patients with HF than without HF. In the HF group, EMPA reduced the risk of incident or worsening nephropathy by 47% (HR 0.53 [95% CI: 0.36–0.77]) (Figure), consistent with the effects in the overall study population (treatment interaction p-value: 0.42). EMPA reduced progression to macroalbuminuria by 50% (HR 0.50 [0.33–0.75]). The composite of hard renal endpoints (doubling of serum creatinine, initiation of renal replacement therapy, or death from renal disease) was reduced in the overall trial population, and the effect was consistent in the HF subgroup (HR 0.78 [0.36–1.67]) (Figure). The time to first sustained eGFR decline from baseline of =40% was reduced overall with consistency of effect seen in the HF population (HR 0.66 [0.33–1.33]). All effects in patients with HF were consistent with those in the overall study population (p-values for interaction >0.05).

Conclusions: In the EMPA-REG OUTCOME trial, patients with T2D and concomitant HF at baseline were at high risk of progressive CKD. In this vulnerable population, EMPA reduced the risk of clinically relevant kidney events. The renoprotective effects were observed on a background of standard of care and were consistent with those reported for the overall study population. The potential of empagliflozin to slow CKD progression in patients with HF (with or without diabetes) is being further investigated in ongoing trials in patients with reduced (EMPEROR-Reduced) or preserved ejection fraction (EMPEROR-Preserved).

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