What’s the Truth About Budesonide?

Since Lockdown Sceptics reported on Sunday about the remarkable effectiveness of the common asthma treatment Budesonide against COVID-19 – cutting serious disease by 90% according to a study published in the Lancet – a new study has appeared underlining its effectiveness as a Covid treatment.

The first study was part of the STOIC trial at Oxford University and found that 10 of the 73 symptomatic Covid patients in the control group required urgent medical care (e.g. hospitalisation) compared to just one of the 73 symptomatic Covid patients who inhaled Budesonide twice a day. This translates to 87% effectiveness in preventing serious disease. One limitation of the study was that few of the participants were high risk or elderly, with an average age of 45; another was that it was small.

The new study is from the PRINCIPLE trial, also based at Oxford, and uses a larger group (751 using Budesonide, 1,028 in the control group), all of whom are either over 65 or over 50 with a risk-increasing underlying health condition. It found that Budesonide reduced a patient’s time to recovery by an average of three days (11 days compared to 14), and also reduced the chances of a relapse within 28 days.

Disappointingly, however, those who took Budesonide were only slightly less likely to be admitted to hospital – 8.5% compared with 10.3% – and this result was not statistically significant (though the trial is to be expanded which may address this issue).

Professor Richard Hobbs of Oxford University, who co-leads the trial, said: “For the first time we have high-quality evidence of an effective treatment that can be rolled out across the community for people who are at most risk of developing more severe illness from COVID-19. Unlike other proven treatments, Budesonide is effective as a treatment at home and during the early stages of the illness. This is a significant milestone for this pandemic and a major achievement for community-based research.”

On Monday, an alert was sent to the NHS saying the drug can now be used off-label for the treatment of COVID-19 for the over-65s and at-risk over-50s, the Telegraph reports.

This is good news. However, not everyone is convinced. The ‘Swiss Doctor’ notes that the trials have financial ties to Budesonide manufacturer AstraZeneca, and that the results are not as impressive as the newspaper reports might suggest. For example, they use “soft” rather than “hard” endpoints.

In both trials, Budesonide achieved no significant improvement in any “hard endpoint”: in the PRINCIPLE trial, there was no significant difference in hospitalisations, deaths, hospital assessment without admission, oxygen administration, and ICU admission. In the Oxford [STOIC] trial, there was no significant difference in the proportion of people and days with an oxygen saturation below 94%, PCR cycle threshold increase, and FluPRO-measured symptom resolution.

The “soft” endpoints were “self-reported recovery” in PRINCIPLE and “urgent care visits” in STOIC, of which only one patient was actually hospitalised and required oxygen.

The ‘Swiss Doctor’ does concede that there was some indication of benefit to the high-risk in the PRINCIPLE trial: hospitalisation/death risk was lower (8.5% vs 10.3%), oxygen requirement was lower (5.8% vs 8.4%), and ICU admission was lower (1.2% vs 2.2%). However, the trial will need to expand if these differences are to gain statistical significance.

The positive results for Budesonide are certainly welcome, as is the news that the NHS has been given the green light to prescribe it for high-risk groups. Though why not for the low risk under-65s as well? In the STOIC trial it cut the need for urgent care to close to zero in that group. Is that not a worthwhile medical intervention, particularly with all the worry about ‘long Covid’?

It’s fair to say that the 17% reduction in hospitalisation/death among the high risk is disappointing when compared to the impressive 87% reduction in urgent care among the low risk. But it’s still an improvement, and the other indicators – shorter recovery time, reduced need for oxygen and intensive care – are also encouraging.

I should add that what we’re really waiting for are high quality results on the highly promising Ivermectin that are deemed acceptable to the health regulators so that drug can become generally available. No rush, guys. Not like people are dying or anything.

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