Abstract
Introduction: Low dose inhaled corticosteroid-formoterol (ICS-Form) is the recommended reliever for asthma patients prescribed maintenance ICS-Form. Safety of using ICS-Form as reliever with a different maintenance long-acting β2-agonist (LABA) is not known.
Aim: This post-hoc analysis of the 6-mo open-label RELIEF study (Pauwels, PMID:14621086) evaluated safety of as-needed formoterol 4.5μg Turbuhaler (Form) versus salbutamol pMDI 200μg or equivalent (Salb) in asthma patients aged ≥6 yrs taking maintenance Form or salmeterol at entry (96% on ICS).
Methods: The primary outcome for safety of Form versus Salb was a composite of serious adverse events (SAEs) and/or discontinuations due to AEs (DAEs) as in the original study.
Results: Baseline characteristics of patients randomised to as-needed Form or Salb were similar in both LABA groups, but fewer patients on maintenance Form than salmeterol were on high dose ICS (Table). No differences were seen in the primary endpoint between Form and Salb in both groups (Table). More DAEs (mainly non-asthma related and non-serious) were seen with Form vs Salb in the salmeterol group, p<.01.
Conclusions: There was no evidence of increased risk of SAEs and/or DAEs with as-needed Form vs Salb, irrespective of concomitant LABA. Future research may determine the relevance of the observed increase in non-asthma/non-serious DAEs in the salmeterol maintenance group using Form as reliever.
Footnotes
Cite this article as: European Respiratory Journal 2021; 58: Suppl. 65, PA885.
This abstract was presented at the 2021 ERS International Congress, in session “Prediction of exacerbations in patients with COPD”.
This is an ERS International Congress abstract. No full-text version is available. Further material to accompany this abstract may be available at www.ers-education.org (ERS member access only).
- Copyright ©the authors 2021
