Demand for an affordable generic steroid soared after preliminary findings from a study showed it may be effective in reducing deaths from the coronavirus disease 2019 (COVID-19).
Demand for an affordable generic steroid soared after preliminary findings from a study showed it may be effective in reducing deaths from the coronavirus disease 2019 (COVID-19).
In an interview with CNBC, Former FDA Commissioner Scott Gottlieb, MD, said the steroid, dexamethasone (Decadron), could have an “immediate impact” on how providers treat the most severe cases of COVID-19.1
Gottlieb is referring to a preprint study published on medRxiv from several United Kingdom investigators. Preliminary results found that dexamethasone reduced deaths by one-third in patients receiving invasive mechanical ventilation (29% versus 40.7%). The steroid also reduced deaths by one-fifth in patients receiving oxygen without invasive mechanical ventilation, but did not reduce mortality in patients not receiving respiratory support.2
“Dexamethasone is the first drug to be shown to improve survival in COVID-19,” Peter Horby, professor of emerging infectious diseases in the Nuffield Department of Medicine at the University of Oxford, and one of the chief investigators for the trial, said in a press release.3 “The survival benefit is clear and large in those patients who are sick enough to require oxygen treatment, so dexamethasone should now become standard of care in these patients.”
However, since the study results were published last week, demand for the drug has soared. Group purchasing organization Vizient Inc. said orders for dexamethasone soared from nearly 400,000 the week of June 8 to more 2.8 million for the week of June 15, The Wall Street Journal reported.4 According to Vizient’s data, there was a 610% increase in demand by its member hospitals in the week since the initial trial results, with aggregated fill rates dropping from 97% to 54% over a 6-day period.5
The study was part of the Randomised Evaluation of COVid-19 thERapY (RECOVERY) trial, which was established as a randomized clinical trial to test a range of potential treatments for COVID-19.3
Horby and his colleagues set out to study the effects of dexamethasone since corticosteroids “may modulate immune-mediated lung injury and reducing progression to respiratory failure and death,” they wrote in the preprint article.2
In the study, 2104 patients randomly allocated to receive dexamethasone were compared with 4321 patients concurrently allocated to standard care. Dexamethasone 6 mg was given once daily for up to 10 days versus standard care alone. Overall, 21.6% of patients allocated dexamethasone and 24.6% patients allocated standard care care died within 28 days (age adjusted rate ratio 0.83; 95% CI 0.74 to 0.92; P<0.001), according to the study.2
“In patients hospitalized with COVID-19, dexamethasone reduced 28-day mortality among those receiving invasive mechanical ventilation or oxygen at randomization, but not among patients not receiving respiratory support,” the investigators wrote.2
References
1. Feuer, William. Potentially lifesaving coronavirus treatment dexamethasone could have ‘immediate impact,’ former FDA chief says. CNBC. June 16, 2020. https://www.cnbc.com/2020/06/16/potential-coronavirus-treatment-dexamethasone-could-have-immediate-impact-former-fda-chief-says.html
2. Horby P, Shen Lim W, Emberson J, et al. Effect of dexamethasone in hospitalized patients with COVID-19: Preliminary report. Pre-print, medRxiv, June 22, 2020. https://doi.org/10.1101/2020.06.22.20137273
3. Low-cost dexamethasone reduces death by up to one third in hospitalised patients with severe respiratory complications of COVID-19. Press release. University of Oxford; June 16, 2020. Accessed June 25, 2020. http://www.ox.ac.uk/news/2020-06-16-low-cost-dexamethasone-reduces-death-one-third-hospitalised-patients-severe
4. Hopkins, Jared S. Dexamethasone demand soars after positive COVID-19 study. The Wall Street Journal. June 25, 2020. https://www.wsj.com/articles/dexamethasone-demand-soars-after-positive-covid-19-study-11593079202
5. Vizient Data Show 610% Increase in Demand for Dexamethasone after Study Shows Effectiveness for Patients Severely Ill with COVID-19. News Release. Vizient; June 25, 2020. Accessed June 25, 2020. https://newsroom.vizientinc.com/vizient-data-show-610-increase-in-demand-for-dexamethasone-after-study-shows-effectiveness-for-patients-severely-ill-with-covid-19.htm