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Steroid + SABA similar to daily steroid for preventing exacerbations in mild asthma (SYGMA)
Clinical Question
In patients with mild asthma, is as-needed use of an inhaled steroid plus a short-acting beta-agonist as effective as daily use of an inhaled steroid?
Bottom line
Increasingly, studies are showing that as-needed use of an inhaled steroid plus a short-acting beta-agonist (SABA) is as effective or very nearly as effective as the daily use of an inhaled steroid, with much lower cumulative steroid doses. The small benefit in terms of weeks with good symptom control with daily steroid use must be balanced against the cost and long-term effects. 1b
Reference
Study design: Randomized controlled trial (double-blinded)
Funding: Industry
Setting: Outpatient (any)
Synopsis
In this industry-sponsored trial, mild asthma was defined in a patient when it could be controlled by a daily low-dose steroid inhaler or leukotriene inhibitor, but not adequately controlled by intermittent SABAs. In this study, 3849 patients, 12 years and older, with mild asthma were randomized to receive 1 of 3 strategies: (1) placebo inhaler twice daily plus terbutaline 0.4 mg inhaler, as needed; (2) placebo inhaler twice daily plus budesonide 160 mcg/formoterol 4.5 mcg, as needed; and (3) budesonide 160 mcg twice daily plus terbutaline 0.4 mg inhaler, as needed. Patients were enrolled, given a 2- to 4-week run-in period of as-needed terbutaline only, and were followed up for one year. The mean age of patients was 40 years, 20% had a severe exacerbation in the year prior to enrollment, the mean pre-treatment FEV1 was 84%, and 87.4% completed the trial. Patients used a diary to record symptoms. Those in the budesonide maintenance group had a higher percentage of weeks with good control than the other 2 groups that used only as-needed inhalers (44% vs 34% for prn budesonide/formoterol vs 31% for prn terbutaline; P < .05). Over one year, this amounts to 5 additional weeks of good control for patients using a maintenance steroid inhaler compared with those using budesonide/formoterol as needed only. Both the budesonide maintenance and the budesonide/formoterol groups had significantly lower rates of severe exacerbations than the terbutaline only group (0.09 vs 0.07 vs 0.20, respectively). For moderate to severe exacerbations, the rates were also significantly lower for the regimens containing budesonide than for as-needed terbutaline only (0.14 vs 0.36). The overall steroid dose given to patients in the as-needed budesonide/formoterol group was approximately one-fifth that of those using maintenance steroid therapy.
Reviewer
Mark H. Ebell, MD, MS
Professor
University of Georgia
Athens, GA
Comments
Not a SABA
Whoever prepared this poem has made an error. The Formoterol is not a SABA, but a LABA.
The key message (Bottom Line) is therefore incorrect and misleading to anyone who does not read the full study or synopsis.
Not sure who created POEMs or if the Bottom line is taken from the study, but the information here is confusing at best. Whoever prepared this poem appears to have made an error. The Formoterol is not a SABA, but a LABA. The key message (Bottom Line) is therefore incorrect and misleading to anyone who does not read the full study or synopsis. (Unless I am missing something in the wording?)
title
they could also have included "Steroid plus LABA PRN" as the suggestion is regular use which would be a silly study.
I suspect some of our patients use their medication like this and have found by experience that it is just as good as regular expensive steroids.
The question is, is this study only accurate for this type of dosing for the budesonide/fometerol combination or can it be extrapolated to other saba/steroid combinations as well.
I thought that fometerol is the only saba that had an indication for emergency use and this could be a confounding factor
Good poem
It is my understanding that the use of low dose steroid was able to keep inflammation down and help ameliorate the slow long term deterioration of the lung tissue. Besides this even five weeks of significant symptom free period I would think would be appreciated. What is the harm of using low dose topical steroids in the lungs on a regular basis?
SYGMA
Similar to previous comments, I agree that the way this POEM was created is misleading and really should be corrected. Being a practicing respirolgist and having had reviewed this study in detail, I completely disagree with the title and bottom line. The study looked at use of Symbicort (ICS+LABA) as needed versus regular use of ICS and really cannot be extrapolated to all ICS/LABA combinations given unique nature of formeterol and should not be extrapolated to say that using ICS + SABA as needed is same as daily ICS. There is no evidence for that and the statement as listed here is misleading and could be potentially dangerous in terms of patient care. I would suggest reviewing this and issuing a correction. Best regards.
Confusing, poorly written, especially, (once again), regarding concluding title and results.
Very interesting trial. I will consider advocating for more prn ICS use (particularly with budesonide, I suppose) in my patients. I know that this is something I was not recommending to my patients previously, but will strongly consider adjusting my practice in coordination with patient values.