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Wednesday, September 2, 2020

New analysis of COVID-19 studies show mortality benefit of cheap steroids

A meta-analysis of pooled data from seven completed studies involving 1,703 critically ill COVID-19 patients showed that the administration of corticosteroids reduced mortality compared to standard-of-care (SOC) treatment. The results were just published online in Journal of the American Medical Association (JAMA).

Patients were randomized to receive systemic dexamethasone, hydrocortisone or methylprednisolone on top of SOC treatment or placebo + SOC. The primary outcome measure was all-cause mortality 28 days after randomization.

The overall 28-day all-cause mortality rate was 38.0% (n=647/1,703). The mortality rate in patients receiving corticosteroids was 32.7% (n=222/678) compared to 41.5% (n=425/1,025) in those receiving SOC only. Results were consistent across the studies.

Results from an Oxford University-led study, RECOVERY, reported almost three months ago, showed a similar mortality benefit from dexamethasone in severely ill patients on ventilators, cutting the risk of death by 28 – 40%. Mortality risk was reduced by 20 – 25% in COVID-19 patients receiving supplemental oxygen. It did not appear to help patients with milder symptoms.

These corticosteroids have been off patent for years and are available at low prices worldwide. In England, for example, a 10-day regimen of dexamethasone only costs ~£5 per patient. In the U.S., a 10-tablet regimen of dexamethasone is available for ~$6, prednisone for a bit less.

By comparison, Gilead Sciences’ (GILD +1.1%) Vektury (remdesivir) costs $390/vial or $2,340/five-day course.

A Phase 3 study, SIMPLE-Severe, showed a mortality rate of 7.6% at day 14 in severely ill COVID-19 patients receiving remdesivir + SOC compared to 12.5% for SOC alone, implying a 39.2% relative reduction in mortality risk (the company reported 62% less risk based on an adjusted odds ratio of 0.38. This approach holds other variables constant and provides the odds ratio for the variable of interest, in this case, mortality).


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