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Single maintenance and reliever therapy more effective than inhaled steroids and short-acting B-agonists for asthma (SMART)
Clinical Question
Is single maintenance and reliever therapy more effective than inhaled corticosteroids with or without LABA as the controller and short-acting B-agonists as the relief therapy for asthma?
Bottom line
Single maintenance and reliever therapy (SMART) compared with standard therapy—inhaled corticosteroids (ICS) with or without long-acting B-agonists (LABAs) and short-acting B-agonists (SABAs) as the relief therapy—is associated with a reduced risk of acute asthma exacerbations in patients 12 years or older. Evidence is limited for children aged 4 to 11 years. Most (15) of the 16 studies evaluated SMART versus standard therapy using a combination of budesonide and formoterol in a dry-powder inhaler as needed to a maximum of 10 inhalations daily. 1a-
Reference
Study design: Meta-analysis (randomized controlled trials)
Funding: Government
Setting: Various (meta-analysis)
Synopsis
Until recently, standard therapy consisted of ICS with or without LABAs as the controller therapy for patients with asthma, augmented with SABAs for as-needed quick relief of symptoms. These investigators thoroughly searched multiple sources, including MEDLINE, EMBASE, the Cochrane databases, clinical trial registries, manufacturers' data, and bibliographic references, for studies that compared standard therapy to SMART, in which the combination of ICS and LABA is used as both the controller and quick relief therapy. No language restrictions were applied. Two reviewers independently evaluated potential studies for inclusion and used a standard scoring tool to assess methodologic quality. Disagreements were resolved by consensus discussion with a third reviewer. A total of 16 randomized controlled trials (N = 22,748 patients) met inclusion criteria. Of these, 15 evaluated SMART as a combination of budesonide and formoterol in a dry-powder inhaler. Six of the studies were considered to have a high risk of bias; the rest were considered at low risk of bias. Asthma exacerbations included a composite outcome of requiring systemic corticosteroids, hospitalization, or emergency department visits. Among patients at least 12 years old, SMART was significantly associated with a reduced risk of asthma exacerbations compared with standard therapy with either the same or a higher dose of ICS alone (numbers needed to treat [NNT] = 12.3, 95% CI 8.7 - 22.2; and 9.1, 6.8 - 13.9, respectively). Similarly, SMART was significantly associated with a reduced risk of asthma exacerbations compared with standard therapy with either the same or a higher dose of ICS and LABAs (NNT = 15.6, 9.8 - 38.5; and 37.0, 19.2 - 33.3, respectively). There was no significant difference in SMART versus standard therapy in overall quality-of-life scores. Limiting the analysis to only studies at low risk of bias did not change the results. Only one trial evaluated SMART versus standard therapy in children aged 4 years to 11 years and the results were inconclusive. A formal analysis for publication bias was not possible because of the small number of studies. Formal testing found minimal evidence of significant heterogeneity of results.
Reviewer
David C. Slawson, MD
Professor and Vice Chair of Family Medicine for Education and Scholarship
Atrium Health
Professor of Family Medicine, UNC Chapel Hill
Charlotte, NC
Comments
good poem
Excellent review of a new piece of information that I will discuss with fellow primary care providers. I can see this changing my practice and simplifying the management of asthma for many of my patients.
I do believe the combination products are not available in generic, though, so are more expensive for patients.
SMART vs standard therapy for asthma
The POEM does not tell us exactly what SMART is. My understanding, is that it is salbutamol alone for maintenance and relief of exacerbations. And those patients in that arm, did better. Does this mean that we get rid of inhaled corticosteroids alone and in combination???? I need to read the original article to understand this better.
SMART vs standard therapy for asthma correction
I went to the abstract and I see now that SMART (in 15 of the 16 studies included) consisted of budesonide and formoterol as a dry powder inhaler, and it was used both as maintenance therapy and reliever for exacerbations. This was superior to ICS alone or in combination with LABA as maintenance therapy, and using SABA as reliever. So in fact, salbutamol is less effective for prevention and treatment of exacerbations, compared to using the combination budesonide and formoterol dry powder inhaler as the reliever. So I misunderstood the article in my prior comment. My apologies. So this suggests throw out salbutamol for patients with persistent asthma. In the abstract I could see the RR reductions, rather than the NNT.
But I couldn't readily link to the entire article. How much did the children lose growth rates? Extra thrush? Extra pneumonia? Very interesting article. I guess I need to ask a librarian to send me a copy of the entire article.
OHIP + doesn't cover single maintenance and reliever therapy for my patients (17-25 yo university students) which will make it very difficult to implement in practice. In order to justify coverage through exceptional access I have to fill out forms attesting failure of or side effects to inhaled corticosteroids with or without LABA as the controller and short-acting B-agonists. Government interfering with optimized care....
It would be essential to obtain unpublished studies data to check there is no significant publication bias which could falsely lead to a conclusion of superiority.
Given that I was one of the investigators for the SMART study, I am quite aware of the results, and have been using the information since.