In a major change to the management of patients with mild asthma, the Global Initiative for Asthma (GINA) has recommended against starting any patients with asthma on short-acting β2 agonist (SABA) relievers alone.
Instead, GINA recommends that all adults and adolescents from 12 years are treated with a more equal focus on symptom relief and preventing severe exacerbations and potential deaths.
Chair of the GINA Science Committee Professor Helen Reddel told the limbic that the background to the change included the risk of severe outcomes including near fatal and fatal exacerbations even in patients with deceptively mild or infrequent asthma symptoms.
And there was evidence from the 2018 SYGMA studies – here and here – that as-needed, low dose budesonide-formoterol on its own was as good at preventing severe exacerbations as regular low-dose inhaled corticosteroids and ‘spectacularly better’ than a SABA reliever inhaler on its own – reducing severe exacerbations by 64%.
Professor Reddel said while not yet available in Australia – PBAC will consider an application for low dose budesonide-formoterol as a first-line treatment for mild asthma at its July 2019 meeting – the recommended management change was revolutionary.
“This is an absolutely fundamental change. I describe this as the most important change in asthma management recommendations in 30 years because ever since the very first asthma guidelines published in Australia in 1989, it’s been recommended that the initial treatment of asthma should be with just a SABA alone.”
She said the pivotal 2018 studies, on which she was a co-author, were a long time coming due to an initial lack of interest from the pharmaceutical industry.
“This is very much an initiative of GINA and clinicians,” she said.
“If we were inventing asthma treatment today, if this was a new disease, I don’t think we would ever do it by treating symptomatically with something that doesn’t also provide protection from severe flare-ups.”
She said the recommendation against SABA only treatment was for adults and adolescents regardless of their asthma severity.
“The priority is to avoid people just being on SABA. The recommendation for as-needed preventer treatment is specifically for people with mild asthma. Once the asthma is moderate or severe, then patients absolutely need daily treatment.”
Acceptance of change will be slow
Professor Reddel, from the Woolcock Institute of Medical Research at the University of Sydney, said the very long history of reliance on salbutamol in mild asthma will make change slow.
“The conversation between a doctor and a patient about treating hypertension is all about risk reduction. There are no symptoms; it’s all about preventing a heart attack or a stroke.”
“But in asthma, the symptoms are much more present to the patients. And this remote possibility that you might have a severe exacerbation is much less in the patients’ consciousness.”
She said changing the conversations to also prioritise risk reduction when patients know and trust their relievers would take time and more consistent messaging.
“In Australia we have this particular challenge that anyone with symptoms can buy salbutamol over the counter, without having to even have a diagnosis. That makes it even more challenging because we don’t just have to reach GPs, we have to reach patients directly.”
“Obviously getting regulatory approval is the first step and getting funded on PBS will also help to avoid SABA only treatment. For some patients cost is absolutely an important issue.”
Professor Reddel said the extensive safety record of budesonide-formoterol and years of clinical experience in the community, as well as the recent clinical trials, provided the basis for GINA confidence to recommend it for symptom relief and for preventing exacerbations in mild asthma.
However, since this medication was not available in many countries, GINA also recommended options such as taking an ICS inhaler whenever SABA is taken as an alternative strategy to achieve the goal of avoiding SABA-only treatment and preventing exacerbations, for adults and adolescents with asthma.