DARE-19 supports continuing SGLT2 inhibitors in event of SARS-CoV-2 infection
medwireNews: Dapagliflozin does not significantly alter outcomes in patients with or without diabetes who are hospitalized with COVID-19, show the DARE-19 trial findings.
However, dapagliflozin treatment resulted in a numerical reduction in the co-primary endpoint of organ failure or death, and there were numerically fewer serious adverse events in patients given the sodium-glucose cotransporter (SGLT)-2 inhibitor than in those given placebo.
“Our results therefore do not support discontinuation of SGLT2 inhibitors in a setting of COVID-19, as long as patients are monitored,” said researcher Mikhail Kosiborod (Saint Luke’s Mid America Heart Institute, Kansas City, Missouri, USA).
For DARE-19, a total of 625 patients with “confirmed or highly clinically suspected” COVID-19 were randomly assigned to receive dapagliflozin 10 mg/day, and the same number were assigned to receive placebo, he told delegates at the virtual American College of Cardiology 70th Annual Scientific Session.
These patients were aged around 61 years, on average, the majority had hypertension, and about half had type 2 diabetes (people with type 1 diabetes were not enrolled).
Given the ability of SGLT2 inhibitors to reduce the risk for organ damage and “favorably affect a number of pathophysiologic pathways disrupted in acute illness,” Kosiborod and team hypothesized that they might be protective in COVID-19 patients; hence the co-primary endpoint of time to organ failure or death from any cause.
This outcome occurred in 11.2% of the dapagliflozin group and 13.8% of the placebo group, which was not a significant difference. Event rates were also numerically fewer in the dapagliflozin than placebo group for all individual endpoints (respiratory, cardiac, or kidney decompensation, or death from any cause). But again, there were no statistically significant differences.
The co-primary endpoint of recovery was also not significantly different between the two treatment groups, and neither were the key secondary endpoints of a composite kidney outcome and all-cause mortality, although again these slightly favored dapagliflozin.
Kosiborod noted that the theoretical risk for acute kidney injury and diabetic ketoacidosis in acutely ill patients had led some groups to recommend SGLT2 inhibitor discontinuation in the event of SARS-CoV-2 infection.
However, acute kidney injury was numerically less frequent in patients taking dapagliflozin than placebo, and there were just two instances of diabetic ketoacidosis, both in the dapagliflozin group, that were non-severe and involved patients with a history of type 2 diabetes.
medwireNews is an independent medical news service provided by Springer Healthcare Ltd. © 2021 Springer Healthcare Ltd, part of the Springer Nature Group
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