• Alberto Papi, Giacomo Forini, Mauro Maniscalco, Elena Bargagli, Claudia Crimi, Pierachille Santus, Antonio Molino, Valeria Bandiera, Federico Baraldi, Silvestro Ennio D'Anna, Mauro Carone, Maurizio Marvisi, Corrado Pelaia, Giulia Scioscia, Vincenzo Patella, Maria Aliani, Leonardo M Fabbri, and ICSLIFE Study Group.
• Respiratory Medicine, Department of Translational Medicine, University of Ferrara, Ferrara, Italy; Respiratory Unit, CardioRespiratory Department, University Hospital Ferrara, Ferrara, Italy. Electronic address: ppa@unife.it.
• Eur. J. Intern. Med. 2024 Oct 1; 128: 104111104-111.

IntroductionPatients with chronic obstructive pulmonary disease (COPD) frequently have cardiovascular comorbidities, increasing the risk of hospitalised COPD exacerbations (H-ECOPDs) or death. This pragmatic study examined the effects of adding an inhaled corticosteroid (ICS) to long-acting bronchodilator(s) (LABDs) in patients with COPD and cardiac comorbidities who had a recent H-ECOPD.MethodsPatients >60 years of age with COPD and ≥1 cardiac comorbidity, within 6 months after discharge following an H-ECOPD, were randomised to receive LABD(s) with or without ICS, and were followed for 1 year. The primary outcome was the time to first rehospitalisation and/or all-cause death.ResultsThe planned number of patients was not recruited (803/1032), limiting the strength of the conclusions. In the intention-to-treat population, 89/403 patients (22.1 %) were rehospitalised or died in the LABD group (probability 0.257 [95 % confidence interval 0.206, 0.318]), vs 85/400 (21.3 %) in the LABD+ICS group (0.249 [0.198, 0.310]), with no difference between groups in time-to-event (hazard ratio 1.116 [0.827, 1.504]; p = 0.473). All-cause and cardiovascular mortality were lower in patients receiving LABD(s)+ICS, with relative reductions of 19.7 % and 27.4 %, respectively (9.8 % vs 12.2 % and 4.5 % vs 6.2 %), although the groups were not formally statistically compared for these endpoints. Fewer patients had adverse events in the LABD+ICS group (43.0 % vs 50.4 %; p = 0.013), with 4.9 % vs 5.4 % reporting pneumonia adverse events.ConclusionsResults suggest addition of ICS to LABDs did not reduce the time-to-combined rehospitalisation/death, although it decreased all-cause and cardiovascular mortality. ICS use was not associated with an increased risk of adverse events, particularly pneumonia.Copyright © 2024 European Federation of Internal Medicine. Published by Elsevier B.V. All rights reserved.

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