- Dexamethasone is a reputable anti-inflammation steroid already available in the market
- India has over Rs 100 crore market with numerous Dexamethasone manufacturers
- Main Dexamethasone brands are from Zydus Cadila and Wockhardt
- Trial with 2,104 patients show Dexamethasone reduced deaths by one-third in ventilated patients and one-fifth in patients on oxygen support
Dexamethasone, a time-tested steroid used to treat inflammation, can reduce death up to one-third in hospitalised patients with severe respiratory complications of COVID-19, an important large clinical trial has said.
The RECOVERY (Randomised Evaluation of COVid-19 thERapY) trial, initiated by the University of Oxford and funded by many agencies, to test efficacy of existing drugs in COVID-19 treatment with low-dose Dexamethasone in 2,104 patients in the UK showed the drug reduced deaths by one-third in ventilated patients (rate ratio - 0.65), and by one-fifth in other patients receiving oxygen only (0.80). There was no benefit among those patients who did not require respiratory support (1.22).
"Based on these results, one death would be prevented by treatment of around 8 ventilated patients or around 25 patients requiring oxygen alone. Given the public health importance of these results, we are now working to publish the full details as soon as possible," the investigators said in a statement.
Peter Horby, Professor of Emerging Infectious Diseases in the Nuffield Department of Medicine, University of Oxford, and one of the Chief Investigators for the trial, said "Dexamethasone is the first drug to be shown to improve survival in COVID-19. 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," he said.
Dexamethasone is inexpensive, on the shelf, and can be used immediately to save lives worldwide.
In India the drug has a market of over Rs 100 crore and has numerous manufacturers. The leading brand Dexona is made by Zydus Cadila and Wockhardt also has sizable market share, said industry sources.
In March, the RECOVERY trial was initiated to test a range of potential treatments for COVID-19 and the drugs Lopinavir-Ritonavir (commonly used to treat HIV), low-dose Dexamethasone, Hydroxychloroquine (which has now been stopped due to lack of efficacy), Azithromycin (a commonly used antibiotic), Tocilizumab (an anti-inflammatory treatment given by injection) and Convalescent plasma. Over 11,500 patients have been enrolled from over 175 NHS hospitals in the UK.
A total of 2,104 patients were randomly dosed with Dexamethasone 6 mg once per day (either by mouth or by intravenous injection) for ten days and were compared with 4,321 patients randomised to usual care alone.
The news follows the decision of the US drug regulator's decision to revoke Emergency Use Authorisation (EUA) for anti-malarial drug hydroxychloroquinone, mainly made by Indian companies Zydus Cadila and Ipca Laboratories.