Kidney Week

Abstract: PO2529

Dapagliflozin and Kidney Outcomes in Hospitalized Patients with COVID-19 Infection: Results from the DARE-19 Randomized Controlled Trial

Session Information

• Late-Breaking Clinical Trials Posters
  November 04, 2021 | Location: On-Demand, Virtual Only
  Abstract Time: 10:00 AM - 12:00 PM

Category: Coronavirus (COVID-19)

• 000 Coronavirus (COVID-19)

Authors

• L Heerspink, Hiddo Jan, University of Groningen, Groningen, Netherlands

Hiddo Jan L Heerspink,

• Furtado, Remo, Instituto do Coracao do Hospital das Clinicas da FMUSP, Sao Paulo, Brazil

Remo Furtado,

• Berwanger, Otavio, Academic Research Organization-Hospital, Sao Paulo, Brazil

Otavio Berwanger,

• Koch, Gary G., University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States

Gary G. Koch,

• Martinez, Felipe, National University of Córdoba, Córdoba, Argentina

Felipe Martinez,

• Mukhtar, Omar, University of Cambridge, Cambridge, Cambridgeshire, United Kingdom

Omar Mukhtar,

• Verma, Subodh, Li Ka Shing Knowledge Institute of St Michael's Hospital, Toronto, Ontario, Canada

Subodh Verma,

• Gasparyan, Samvel B., AstraZeneca, Gothenburg, Sweden

Samvel B. Gasparyan,

• Tang, Fengming N., Saint Luke's Mid America Heart Institute, Kansas City, Missouri, United States

Fengming N. Tang,

• Windsor, Sheryl L., Saint Luke's Mid America Heart Institute, Kansas City, Missouri, United States

Sheryl L. Windsor,

• Buenconsejo, Joan, AstraZeneca, Gaithersburg, Maryland, United States

Joan Buenconsejo,

• Esterline, Russell L., AstraZeneca, Gaithersburg, Maryland, United States

Russell L. Esterline,

• Oscarsson, Jan, AstraZeneca, Gothenburg, Sweden

Jan Oscarsson,

• Ambery, Philip D., AstraZeneca, Gothenburg, Sweden

Philip D. Ambery,

• Langkilde, Anna Maria, AstraZeneca, Gothenburg, Sweden

Anna Maria Langkilde,

• Kosiborod, Mikhail, The George Institute for Global Health, Newtown, New South Wales, Australia

Mikhail Kosiborod,

Background

Hospitalized patients with COVID-19 infection are at high risk of acute kidney injury (AKI) and renal replacement therapy, especially in the presence of chronic kidney disease (CKD). The DARE-19 trial showed that in hospitalized patients with COVID-19, treatment with dapagliflozin (DAPA) vs placebo resulted in numerically fewer patients experiencing organ failure or death, although these differences were not statistically significant. We performed a pre-specified secondary analysis of DARE-19 to determine the efficacy and safety of DAPA on kidney outcomes in the overall population and by CKD status.

Methods

The DARE-19 trial randomized 1250 hospitalized patients (231 [18.5%] had eGFR <60 mL/min/1.73m²) with COVID-19 and cardiometabolic risk factors to DAPA or placebo. Dual primary outcomes (time to new or worsened organ dysfunction or death, and a hierarchical composite endpoint of recovery [change in clinical status by Day 30]), and the specific kidney outcome (composite of AKI, renal replacement therapy or death), as well as safety were assessed in patients with baseline eGFR <60 and ≥60 mL/min/1.73m².

Results

The effect of DAPA vs placebo on the primary prevention outcome (hazard ratio [HR] 0.80 [95%CI 0.58, 1.10]) and primary recovery outcome (win ratio 1.09 [95%CI 0.97, 1.22]) was consistent across eGFR subgroups (p for interaction 0.98 and 0.67, respectively). The effect on the composite kidney outcome (HR 0.74 [95%CI 0.50, 1.07]) was also consistent in eGFR subgroups (p for interaction 0.44). There were numerically fewer AKI events with DAPA in patients with eGFR<60 ml/min/1.73m² (HR 0.71 [95%CI 0.29, 1.77]) and ≥60 ml/min/1.73m² (HR 0.69 [95%CI 0.37, 1.29]). DAPA was well tolerated in patients with eGFR <60 and ≥60 mL/min/1.73m².

Conclusion

The effects of DAPA on primary and secondary outcomes in hospitalized patients with COVID-19 were consistent in those with/without CKD. DAPA was well tolerated and did not increase the risk of AKI in patients with/without CKD.

Funding

• Commercial Support – AstraZeneca