OBJECTIVES: To determine the complications (exacerbations, pneumonia) in patients with inhaled corticosteroids (IC) replaced by long-acting muscarinic antagonists (LAMA) in dual therapy for the treatment of COPD usual clinical practice.

METHODS: Retrospective, observational study (before/after with control group) carried out by review of medical records. The study included patients aged ≥40 years who had been on treatment for ≥ 1 year with IC/long-acting beta agonists (LABA) in whom IC were replaced by a LAMA (index-date) during 2014-2017 (recruitment period). Study groups: a) IC/LABA (without replacement, dual therapy) and b) LABA/LAMA (replacement of IC, dual bronchodilation). Data were collected for a reference period before the index date and a follow up period of one year. Each patient in the LABA/LAMA group was matched with one in the IC/LABA group by propensity score matching (PSM). Main measures: comorbidity, medication, IC dose, exacerbations and pneumonia. The statistical analysis was carried out using multivariate-models (p<0.05).

RESULTS: 2,366 patients were recruited, and IC were replaced by LAMA in 19.9% (N = 464). After PSM the study groups were: a) IC/LABA N = 462, and b) LABA/LAMA N = 462, the mean age was 71.8 years and 80.3% were male (Charlson index: 0.9). The mortality rate was 10.4%, severe COPD 35.5%, 13.9 received high daily IC doses, FEV1 was 54.9% and 8.5% received home oxygen therapy. By study groups, the results were similar: 22.4% showed some type of exacerbation (IC/LABA: 21.4% vs. LABA/LAMA: 23.4%; p=0.478). Severe exacerbations (IC/LABA: 5.6% vs. 6.3%, p=0.675), and total exacerbations before the study period (22.7% vs. 22.9%, p=0.938) were similar.

CONCLUSIONS: Relatively few patients received replacement of IC by LAMA. Comparisons showed IC/LABA (dual therapy) and LABA/LAMA (dual bronchodilation) were associated with similar rates of exacerbation, pneumonia and use of health resources. However, further studies will be needed to reinforce the consistency of the results.