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EMA Supports Severe COVID-19 Dexamethasone After Data Review

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Editor’s Note: Find the latest COVID-19 news and guidance from Medscape Coronavirus Resource Center.

European Medicines Agency (EMA) Approved for use of dexamethasone Oxygen or for patients with COVID-19 Mechanical ventilationFollowing a review of recovery studies by the Commission on Medicines for Human Use.

Dexamethasone The EMA states that it can be considered as a treatment option for adults and adolescents (aged 12 years and older, weighing 40 kg or more) with SARS-CoV-2 infections who require oxygen replacement therapy.

Dexamethasone can be given by mouth, injection, or infusion. In all cases, the recommended dose for adults and adolescents is 6 mg once daily for up to 10 days.

As part of a recovery trial, patients admitted with COVID-19 were randomly assigned to oral or intravenous dexamethasone (6 mg once daily) for up to 10 days, or were assigned to regular care only.

Overall, 482 patients (22.9%) who received dexamethasone and 1110 patients (25.7%) who received routine care died within 28 days of randomization.

Preliminary results show that dexamethasone reduced mortality in patients on invasive ventilation by about 35% and by about 20% in patients receiving oxygen without invasive ventilation compared to conventional care. Is shown.

There was no reduced risk of death in patients who did not receive oxygen therapy or mechanical ventilation.

Result is Release In New England Journal medicineJuly of e.

“These results include additional publications, including a meta-analysis conducted by the World Health Organization (WHO) that examined data from seven clinical studies investigating the use of corticosteroids for the treatment of COVID-19 patients. Supported by data, “said in a statement announcing the approval of dexametazone for EMA severe COVID-19.

The agency said that companies selling dexamethasone drugs could submit an application to a national drug agency or EMA to require that this new use be added to the license for their product. It was.

Proposed changes to dexamethasone Product information Available online for patients and healthcare professionals.

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