Shawn D. Aaron, MD
In adults with chronic obstructive pulmonary disease (COPD), how effective are combined inhaled corticosteroid (ICS) plus long-acting β2-agonist (LABA) preparations compared with LABAs alone?
Included studies compared combined ICS plus LABA (ICS/LABA) inhalers (fluticasone and salmeterol [FPS] or budesonide and formoterol [BDF]) with the same LABA alone in adults > 40 years of age who had stable COPD and had not had an exacerbation in the past month. Studies of patients who had partial reversibility on pulmonary function testing were included. Studies that included patients with asthma, cystic fibrosis, bronchiectasis, thoracic surgery, or other lung or significant diseases were excluded. Outcomes included mortality, exacerbation (as defined by individual studies, but usually ≥ 48 h of increased COPD symptoms requiring a change in treatment = moderate exacerbation) rate ratio, number of patients with ≥ 1 exacerbation, pneumonia, and health-related quality of life (St. George's Respiratory Questionnaire [SGRQ], minimal clinically important difference 10 units).
Cochrane Airways Group Specialised Register of trials (Nov 2011), which includes studies identified from Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE/Excerpta Medica, CINAHL, AMED, PsycINFO, and hand searches of respiratory journals and meeting abstracts; LILACS (Mar 2011); Cochrane CENTRAL (Issue 1, 2011); and reference lists were searched for randomized, double-blind trials. Online trial registries of GlaxoSmithKline and AstraZeneca, and ClinicalTrials.gov were consulted. 14 trials (n = 11 794) met the selection criteria: 10 assessed FPS, and 4 assessed BDF. Study durations included 8 weeks (1 trial), 24 weeks (4 trials), 52 weeks (8 trials), and 156 weeks (1 trial). Quality of evidence, assessed with the Grading of Recommendations Assessment, Development, and Evaluation criteria, was low for exacerbation rate and moderate for mortality, patients with ≥ 1 exacerbation, and pneumonia.
Compared with LABAs alone, ICS/LABA preparations reduced the number of patients with exacerbations and the exacerbation rate ratio, increased risk for pneumonia, and did not affect mortality (Table). FPS (difference in change 1.58 SGRQ units, 95% CI 1.01 to 2.15) and BDF (difference in change 2.69 SGRQ units, CI 1.55 to 3.82) each increased quality of life more than LABAs alone.
In adults with chronic obstructive pulmonary disease, combined inhaled corticosteroid plus long-acting β2-agonist (LABA) preparations reduce risk for exacerbations, increase pneumonia, and improve quality of life, but do not affect mortality, compared with LABAs alone.
Combined ICS/LABA inhalers vs LABA alone in chronic obstructive pulmonary disease*
*ICS = inhaled corticosteroid; LABA = long-acting β2-agonist; NA = not applicable; other abbreviations defined in Glossary. Weighted event rates, RRR, RRI, NNT, NNH, and CI calculated from data in article using a random effects model.
†Compares exacerbations per patient-year between treatment groups.
Aaron SD. Review: Corticosteroid plus LABA inhalers, vs LABAs alone, reduce morbidity in COPD. Ann Intern Med. ;158:JC9. doi: 10.7326/0003-4819-158-4-201302190-02009
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Published: Ann Intern Med. 2013;158(4):JC9.
Chronic Obstructive Airway Disease, Pulmonary/Critical Care.
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