Dapagliflozin fails to show a significant protective effect in COVID-19

Dapagliflozin did not achieve statistical significance for the primary endpoints of prevention of organ dysfunction or recovery when administered to patients with COVID-19 in the DARE-19 trial. However, there were numerically fewer occurrences of organ failure and death with dapagliflozin compared with placebo and numerically fewer adverse events than with the placebo.

Prof. Mikhail Kosiborod (Saint Luke’s Mid America Heart Institute, MO, USA) presented the results of the DARE-19 (NCT04350593) trial [1]. DARE-19 was an international, multicentre, randomised, double-blind, placebo-controlled study of 1,250 patients who were hospitalised with COVID-19. These patients were at high risk for multiple organ failure and death. Dapagliflozin, a sodium-glucose cotransporter-2 (SGLT2) inhibitor, is known to have a protective effect in conditions such as type 2 diabetes, heart failure, and chronic kidney disease. Investigators hypothesised that this protective effect could also extend to patients with COVID-19. Patients were randomised to receive either 10 mg of dapagliflozin per day (n=625) or a placebo (n=625) for 30 days. Dual primary endpoints were prevention of organ failure –cardiac, respiratory, or kidney decompensation– or death from any cause, and recovery.

At 30 days, 86 events of organ failure or death had occurred in the placebo group (13.8%) and 70 events in the dapagliflozin group (11.2%) (HR 0.80; 95% CI 0.58–1.10; P=0.168) (see Figure). In terms of recovery, 57% of the patients in the dapagliflozin group and 57.3% of the patients in the placebo group were discharged by day 6. There were fewer adverse events in the dapagliflozin group than in the placebo group.

Figure: Primary endpoint (i.e. organ failure or death at 30 days) in the DARE-19 trial [1]



 

Prof. Kosiborod concluded that this evidence does not support the discontinuation of SGLT2 inhibitors in patients with COVID-19.

1. 
   
   1. Kosiborod MN. Effects of Dapagliflozin On Prevention of Major Clinical Events and Recovery in Patients with Respiratory Failure Due To COVID-19 – Main Results from the DARE-19 Randomised Trial. Abstract 406-11, ACC 2021 Scientific Session, 15–17 May.

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Posted on 9 July 202122 February 2024