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New Study of Diabetes Drug for COVID-19 Raises Eyebrows

What your doctor is reading on Medscape.com:

APRIL 30, 2020 — A just-launched study of the type 2 diabetes agent dapagliflozin (Farxiga, AstraZeneca) in patients with mild-moderate COVID-19 is raising eyebrows, given that several expert groups have advised that drugs in this class — the sodium-glucose cotransporter 2 (SGLT2) inhibitors — be stopped in all patients hospitalized with COVID-19 due to the increased risk for diabetic ketoacidosis (DKA).

The randomized, double-blind, placebo-controlled, phase 3 Dapagliflozin in Respiratory Failure in Patients With COVID-19 (DARE-19) study is sponsored by AstraZeneca and Saint Luke’s Mid America Heart Institute.

The trial will assess whether dapagliflozin reduces the risks of disease progression, clinical complications, and death due to COVID-19 in patients with type 2 diabetes, cardiovascular disease, and/or mild-moderate chronic kidney disease (CKD). 

“Dapagliflozin has demonstrated cardio- and renal-protective benefits and improved outcomes in high-risk patients with type-2 diabetes, heart failure with reduced ejection fraction, and CKD,” said the principal investigator of DARE-19, Mikhail N. Kosiborod, MD, a cardiologist at Saint Luke’s Mid America Heart Institute, Kansas City, Missouri.

And “patients with COVID-19 and underlying cardiometabolic disease appear to be at the highest risk of morbid complications,” he explains in an AstraZeneca statement.

“Through DARE-19, we hope to decrease the severity of illness, and prevent cardiovascular, respiratory, and kidney decompensation, which are common in patients with COVID-19,” Kosiborod continues.

However, advice to stop SGLT2 inhibitors in patients hospitalized with COVID-19, due to its associated DKA risk, has come from several channels.

These include initial guidance from Diabetes UK; experts who spoke during an American Diabetes Association webinar; and most recently, an international panel of diabetes experts.

Some clinicians went so far as to tell Medscape Medical News that they view the trial as potentially dangerous, while others said they could see some logic to it, as long as it is carefully managed.

“A Dangerous Proposition — a DARE I Would Not Take”

Partha Kar, MD, of Portsmouth Hospitals NHS Trust, and national clinical director, diabetes, NHS England, told Medscape Medical News: “It’s interesting to see [AstraZeneca] embark on a study with a particular class of drug whereby…[in] the UK we have said that if you get sent to hospital with COVID-19 you should stop [SGLT2 inhibitors] immediately.”

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