Steroid Dexamethasone approved as Covid-19 treatment in UKApprox Read Time: 5 minutes
- Researchers leading a major clinical trial in the UK have announced that the drug dexamethasone has been found to reduce the risk of death among severely ill patients.
- Consequently, the U.K. government has authorized the State-funded National Health Service (NHS) to use the drug in treatment of all hospitalized COVID-19 patients requiring oxygen, including those on ventilators.
- The drug has also been added to the U.K. government’s parallel export list, which bans companies from buying medicines meant for U.K. patients and selling them on for a higher price in another country.
- According to scientists, the drug has been proven to reduce the risk of death significantly in COVID-19 patients on ventilation by as much as 35% and patients on oxygen by 20%.
- The trial has reported a dose of 6 mg dexamethasone once a day for up to 10 days or discharge if sooner. No benefit is seen for patients hospitalized and not on oxygen.
- The trial is part of the 2.1-million pounds Randomized Evaluation of COVid-19 thERapY (RECOVERY) trial, backed by the U.K. government to explore innovative medicines in the fight against the novel coronavirus.
- With over 177,000 patients enrolled, it is described as the largest randomized clinical trial anywhere in the world and will continue to trial other medicines, such as azithromycin and lopinavir-ritonavir.
Significance of the findings:
- As per medical experts, the dexamethasone findings are very encouraging because the signal on reduced mortality applies to many of the patients admitted to hospitals.
- The UK government believes the trial will impact the global response to the coronavirus pandemic, as the drug is inexpensive and can be used immediately to save lives worldwide.
- Dexamethasone is a steroid that has been used since the 1960s to reduce inflammation in a range of conditions, including inflammatory disorders.
- It has been listed on the WHO Model List of Essential Medicines since 1977 in multiple formulations, and is currently off-patent and affordably available in most countries.
- It is used in the treatment of rheumatic problems, skin diseases, severe allergies, asthma, chronic obstructive lung disease, brain swelling, eye pain following eye surgery and along with antibiotics in tuberculosis.
- It may be taken by mouth or as an injection into a muscle or intravenously. The effects of dexamethasone are frequently seen within a day and last for about three days.
Dexamethasone and Sports:
- Dexamethasone has been used for years by sportspersons to reduce the time of rehabilitation from injuries and recover from infections.
- The drug is on the World Anti-Doping Agency’s (WADA’s) list of prohibited substances, and various sportspersons have been caught using it in the past.
- Athletes are, however, barred from using dexamethasone only during a competition. If the use of the substance is detected prior to a competition, it will not be considered a doping offence, if athletes have the requisite Therapeutic Usage Exemption (TUE).
- The global market for dexamethasone is around $470 million, with around 5.85 billion units sold. The US, EU and Japan are the top markets by value and India, Indonesia and China account for the highest volumes.
- Indian pharmaceutical firms have the largest share of the global volume—around 46 per cent—largely driven by the country’s own consumption of the drug.
- Following the latest findings in the RECOVERY trial, industry executives expect a growth in demand for exports to other countries as well.
- However, the API (active pharmaceutical ingredient) for dexamethasone mostly comes from China and there are very few manufacturers in India.
- The researchers have shared initial insights about the results of the trial with WHO, and WHO will analyze the data to increase the overall understanding of this intervention.
- Post which, the WHO clinical guidance will be updated to reflect how and when the drug should be used in COVID-19.