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  • The renoprotective effects of SGLT2 inhibitors first demonstrated in CREDENCE within a T2DM population have now been confirmed in DAPA-CKD, a trial that also included patients without T2DM

The renoprotective effects of SGLT2 inhibitors first demonstrated in CREDENCE within a T2DM population have now been confirmed in DAPA-CKD, a trial that also included patients without T2DM

The renoprotective effects of SGLT2 inhibitors first demonstrated in CREDENCE within a T2DM population have now been confirmed in DAPA-CKD, a trial that also included patients without T2DM

Patients with chronic kidney disease (CKD) have a high risk of adverse cardiovascular and renal outcomes. Sodium-glucose co-transporter 2 (SGLT2) inhibitors have shown favourable effects on renal and cardiovascular outcomes in large clinical trials involving patients with type 2 diabetes (T2DM), although the majority of patients enrolled in those studies did not have CKD.

Previous findings from the CREDENCE (Canagliflozin and Renal Events in Diabetes with Established Nephropathy Clinical Evaluation) trial, showing that canagliflozin, an SGLT2 inhibitor, improved renal outcomes in patients with T2DM and CKD, are now confirmed in the DAPA-CKD trial with dapagliflozin, and extended to a broader population of people without T2DM, which accounted for 32.5% of participants in this study. Trial findings also confirmed the high mortality among patients with impaired kidney function, as a consequence of a high risk of adverse cardiovascular and renal outcomes.

The DAPA-CKD (Dapagliflozin and Prevention of Adverse Outcomes in Chronic Kidney Disease) study was designed to assess the long-term efficacy and safety of dapagliflozin in patients with CKD. In this double-blind trial, a total of 4304 participants (with or without T2DM) with an estimated glomerular filtration rate (eGFR) of 25 to 75 ml/min/1.73m2 and a urinary albumin-to-creatinine ratio (UACR) of 20 to 500 mg/mmol were randomly assigned to receive dapagliflozin 10 mg or placebo.

The primary outcome was a composite of a sustained decline in eGFR of at least 50%, end-stage kidney disease (ESKD), or death from renal or cardiovascular causes.

In hierarchical order, the secondary outcomes were:

1. A composite renal outcome defined as sustained decline in eGFR of at least 50%, ESKD, or death from renal causes

2. A composite cardiovascular outcome defined as hospitalisation for heart failure or death from cardiovascular causes

3. Death from any cause

Over a median follow-up of 2.4 years, the key findings were:

  • 39% lower relative risk of a composite of sustained decline in eGFR of at least 50%, end-stage kidney disease, or death from renal or cardiovascular causes with dapagliflozin vs. placebo (9.2% vs. 14.5%; hazard ratio, 0.61; 95% confidence interval [CI], 0.51 to 0.72; P<0.001)
  • 29% lower risk of the composite of death from cardiovascular causes or hospitalization for heart failure in patients with dapagliflozin vs. those with placebo (4.6% vs 6.4%, hazard ratio 0.71, 95% CI, 0.55 to 0.92; P=0.009)
  • 31% lower risk of all-cause death in patients who received dapagliflozin vs. those who received placebo (4.7% vs. 6.8%; hazard ratio, 0.69; 95% CI, 0.53 to 0.88; P = 0.004)

Interestingly, these effects seen with dapagliflozin were similar in participants with and without T2DM.

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Editorial Board

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Dr. Salvatore A. De Cosmo's image

Dr. Salvatore A. De Cosmo

Head of Unit of Internal Medicine and Endocrinology, Scientific Institute “Casa Sollievo della Sofferenza” San Giovanni, Rotondo, Italy
,
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Dr. Juan José Gorgojo Martínez's image

Dr. Juan José Gorgojo Martínez

Head of Department of Endocrinology and Nutrition, University Hospital Fundación, Alcorcon, Madrid, Spain
,
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Dr. Patrick Holmes' image

Dr. Patrick Holmes

General Practitioner, St. George's Medical Practice, Darlington, UK

Editorial Board

Image
Dr. Salvatore A. De Cosmo's image

Dr. Salvatore A. De Cosmo

Head of Unit of Internal Medicine and Endocrinology, Scientific Institute “Casa Sollievo della Sofferenza” San Giovanni, Rotondo, Italy
Image
Dr. Juan José Gorgojo Martínez's image

Dr. Juan José Gorgojo Martínez

Head of Department of Endocrinology and Nutrition, University Hospital Fundación, Alcorcon, Madrid, Spain
Image
Dr. Patrick Holmes' image

Dr. Patrick Holmes

General Practitioner, St. George's Medical Practice, Darlington, UK

Publication under Spotlight

Dapagliflozin in Patients with Chronic Kidney Disease

N Engl J Med

2020;383:1436-46.

Authors: Hiddo J.L. Heerspink, Ph.D., Bergur V. Stefánsson, M.D., Ricardo Correa‑Rotter, M.D., Glenn M. Chertow, M.D., Tom Greene, Ph.D., Fan‑Fan Hou, M.D., Johannes F.E. Mann, M.D., John J.V. McMurray, M.D., Magnus Lindberg, M.Sc., Peter Rossing, M.D., C. David Sjöström, M.D., Roberto D. Toto, M.D., Anna‑Maria Langkilde, M.D., and David C. Wheeler, M.D.

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