Shawn D. Aaron, MD, MSc
In patients with stable chronic obstructive pulmonary disease (COPD), how effective and safe is the combination of inhaled long-acting β2-agonists (LABAs) plus inhaled corticosteroids (ICSs) compared with LABAs alone?
Included studies compared a LABA plus an ICS with a LABA alone in patients > 40 years of age with stable, moderate-to-very severe COPD. Outcomes were moderate and severe COPD exacerbations, all-cause mortality, respiratory deaths, cardiovascular deaths, and adverse effects.
MEDLINE, EMBASE/Excerpta Medica, and Cochrane Central Register of Controlled Trials (to May 2009); and drug company clinical trial databases were searched for full reports of randomized controlled trials (RCTs) with duration > 1 month. 18 RCTs (including 5 unpublished trials) (n = 12 446, mean age 64 y, 72% men) met the selection criteria. Adequate concealment of allocation was reported for 5 RCTs; blinding was not reported. 5 RCTs used formoterol/budesonide, and 13 RCTs used salmeterol/fluticasone, with the 2 treatments combined in a single inhaler in all trials. Mean baseline COPD severity was in the “severe” range (FEV1 30% to 50% of predicted) for most trials. 7 RCTs were short-term (< 52 wk), and 11 RCTs were long-term (≥ 52 wk) (range 8 wk to 3 y).
Combined LABA/ICS therapy reduced risk for moderate COPD exacerbations, but not the other efficacy outcomes, compared with LABA alone (Table). Risks for pneumonia, viral respiratory infections, and oropharyngeal candidiasis were increased with combined therapy.
In patients with stable chronic obstructive pulmonary disease, the combination of inhaled long-acting β2-agonists (LABAs) plus inhaled corticosteroids is not more effective than LABAs alone.
Inhaled long-acting β2-agonists (LABAs) plus inhaled corticosteroids vs LABAs alone in patients with stable chronic obstructive pulmonary disease (COPD)*
*Abbreviations defined in Glossary. Weighted event rates, RRR, RRI, NNT, NNH, and CI calculated from data in article using a fixed-effect model.
†A random-effects model was used because of significant statistical heterogeneity among trials.
Aaron SD. Review: Addition of inhaled corticosteroids to long-acting β2-agonists does not improve outcomes in stable COPD. Ann Intern Med. ;152:JC3–5. doi: 10.7326/0003-4819-152-6-201003160-02005
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Published: Ann Intern Med. 2010;152(6):JC3-5.
Chronic Obstructive Airway Disease, Pulmonary/Critical Care.
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