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Dapagliflozin and Kidney Outcomes in Hospitalized Patients with COVID-19 Infection: An Analysis of the DARE-19
Hiddo J L Heerspink1,2, Remo H M Furtado3,4, Otavio Berwanger3
1University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.
Insights
Dapagliflozin showed consistent kidney benefits and safety in hospitalized COVID-19 patients, regardless of baseline kidney function (eGFR). The drug did not increase acute kidney injury (AKI) risk in these patients.
Area of Science:
- Nephrology
- Infectious Diseases
- Cardiology
Background:
- Hospitalized patients with COVID-19 face high risks of acute kidney injury (AKI) and kidney replacement therapy (KRT), particularly those with chronic kidney disease (CKD).
- The DARE-19 trial indicated dapagliflozin numerically reduced organ failure or death in COVID-19 patients, though not statistically significant.
Purpose of the Study:
- To analyze the DARE-19 trial data for dapagliflozin's efficacy and safety on kidney outcomes.
- To assess these effects in the overall COVID-19 patient population and specific subgroups based on estimated glomerular filtration rate (eGFR).
Main Methods:
- A secondary analysis of the DARE-19 trial involving 1250 hospitalized COVID-19 patients with cardiometabolic risk factors.
- Patients were randomized to dapagliflozin or placebo, with kidney outcomes (AKI, KRT, or death) assessed across eGFR subgroups (<60 and ≥60 ml/min per 1.73 m²).
Main Results:
- Dapagliflozin demonstrated consistent effects on primary and secondary outcomes across eGFR subgroups (P interaction > 0.44).
- The drug showed similar effects on preventing AKI in both eGFR subgroups (HR 0.71 for eGFR <60; HR 0.69 for eGFR ≥60).
- Dapagliflozin was well-tolerated in all participants, irrespective of baseline kidney function.
Conclusions:
- Dapagliflozin's benefits and safety profile for primary and secondary outcomes were consistent in hospitalized COVID-19 patients with eGFR below or above 60 ml/min per 1.73 m².
- Dapagliflozin is a well-tolerated treatment option that does not elevate AKI risk in this patient population.
Background And Objectives:
Patients who were hospitalized with coronavirus disease 2019 (COVID-19) infection are at high risk of AKI and KRT, especially in the presence of CKD. The Dapagliflozin in Respiratory Failure in Patients with COVID-19 (DARE-19) trial showed that in patients hospitalized with COVID-19, treatment with dapagliflozin versus placebo resulted in numerically fewer participants who experienced organ failure or death, although these differences were not statistically significant. We performed a secondary analysis of the DARE-19 trial to determine the efficacy and safety of dapagliflozin on kidney outcomes in the overall population and in prespecified subgroups of participants defined by baseline eGFR.
Design, Setting, Participants, & Measurements:
The DARE-19 trial randomized 1250 patients who were hospitalized (231 [18%] had eGFR <60 ml/min per 1.73 m2) with COVID-19 and cardiometabolic risk factors to dapagliflozin or placebo. Dual primary outcomes (time to new or worsened organ dysfunction or death, and a hierarchical composite end point of recovery [change in clinical status by day 30]), and the key secondary kidney outcome (composite of AKI, KRT, or death), and safety were assessed in participants with baseline eGFR <60 and ≥60 ml/min per 1.73 m2.
Results:
The effect of dapagliflozin versus placebo on the primary prevention outcome (hazard ratio, 0.80; 95% confidence interval, 0.58 to 1.10), primary recovery outcome (win ratio, 1.09; 95% confidence interval, 0.97 to 1.22), and the composite kidney outcome (hazard ratio, 0.74; 95% confidence interval, 0.50 to 1.07) were consistent across eGFR subgroups (P for interaction: 0.98, 0.67, and 0.44, respectively). The effects of dapagliflozin on AKI were also similar in participants with eGFR <60 ml/min per 1.73 m2 (hazard ratio, 0.71; 95% confidence interval, 0.29 to 1.77) and ≥60 ml/min per 1.73 m2 (hazard ratio, 0.69; 95% confidence interval, 0.37 to 1.29). Dapagliflozin was well tolerated in participants with eGFR <60 and ≥60 ml/min per 1.73 m2.
Conclusions:
The effects of dapagliflozin on primary and secondary outcomes in hospitalized participants with COVID-19 were consistent in those with eGFR below/above 60 ml/min per 1.73 m2. Dapagliflozin was well tolerated and did not increase the risk of AKI in participants with eGFR below or above 60 ml/min per 1.73 m2.
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