The World Health Organization issued new guidelines Wednesday on the use of lifesaving drugs, hours after a study showed that inexpensive steroids cut death rates in the sickest COVID-19 patients.
The WHO guideline panel made a “strong” recommendation for the use of corticosteroid drug therapy, given orally or through an IV, for COVID-19 patients in critical and serious condition.
The panel made a conditional recommendation against using the same steroids in people with milder COVID-19 cases.
The WHO guidelines were developed in collaboration with the nonprofit Magic Evidence Ecosystem Foundation and were based on the results from eight randomized clinical trials with 7,184 participants.
One of the analyses was published Wednesday in the Journal of the American Medical Association (JAMA).
Dr. Todd Rice, an associate professor of medicine and critical care physician at the Vanderbilt University School of Medicine, who co-authored an editorial in JAMA, told The New York Times newspaper that the results were a confidence booster for medical professionals worried about steroid use in the sickest COVID-19 patients.
“This shows us steroids are clearly beneficial in this population and should clearly be given, unless you absolutely can’t for some reason, which needs to be a pretty rare occasion,” he said.
Researchers with the WHO’s Rapid Evidence Appraisal for COVID-19 Therapies (REACT) Working Group evaluated data on three steroids used in seven randomized clinical trials in 12 countries.
Researchers found the corticosteroid drug dexamethasone reduced death by 36% in 1,282 patients in three separate trials. Hydrocortisone reduced death by 31% in 374 patients in three trials, and methylprednisolone reduced death by 9% in a small 47 patient trial.
The JAMA editorial described the analysis as an “important step forward in the treatment of patients with COVID-19.”
“People are dying from this disease, and we want treatment that we are confident will decrease mortality and save people’s lives,” Rice said.
Though the death rate among the sickest COVID-19 patients remained high, of the six studies that reported serious adverse events, 64 of the events occurred among 354 patients on steroids, while 80 events occurred among the 342 patients receiving standard care.
Initial results showing that dexamethasone could reduce death in critically ill COVID-19 patients came out in mid-June, from the RECOVERY trial led by the University of Oxford.
This was the other meta-analysis WHO used to develop Wednesday’s guidelines update. In the trial, 2,104 patients received the steroid, while 4,321 patients received standard care.
Many of the sickest COVID-19 patients die not from the coronavirus itself but from their immune system’s overreaction to the virus, turning the body on itself. The steroid drugs allow doctors to tamp down the immune system’s response in a controlled way and reduce the inflammation and pain.
The WHO cautioned against using the drugs on people with milder cases, who don’t have the “physiological signs of an inflammatory response that’s leading to respiratory distress,” explained Janet Diaz, the lead for Clinical Management at the WHO’s Emergencies Program.
“The reason we said that [recommendation] is because there was a concern for harm,” she said at a live Q&A Wednesday explaining the WHO guidance.
The data was less clear, she said, contributing to the conditional status of the recommendation. Steroid treatment could hinder healthier patients’ reaction to the virus and worsen their condition.
As of Wednesday, there were nearly 26 million cases of COVID-19 around the world and nearly 900,000 deaths, according to data compiled by Johns Hopkins University. The United States leads in both confirmed cases and deaths.
Leslie Bonilla contributed to this report.
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