RT Journal Article
SR Electronic
T1 Formoterol as relief medication in asthma: a worldwide safety and effectiveness trial
JF European Respiratory Journal
JO Eur Respir J
FD European Respiratory Society
SP 787
OP 794
DO 10.1183/09031936.03.00055803
VO 22
IS 5
A1 R.A. Pauwels
A1 M.R. Sears
A1 M. Campbell
A1 C. Villasante
A1 S. Huang
A1 A. Lindh
A1 W. Petermann
A1 M. Aubier
A1 G. Schwabe
A1 T. Bengtsson
A1 on behalf of the RELIEF Study investigators
YR 2003
UL http://erj.ersjournals.com/content/22/5/787.abstract
AB The aim of the study was to compare the safety and effectiveness of as-needed formoterol with salbutamol in a large international real-life asthma study. Children and adults (n=18,124) were randomised to 6 months as-needed treatment with open-label formoterol 4.5 µg Turbuhaler® or salbutamol 200 µg pressurised metered dose inhaler or equivalent. Primary safety variables were asthma-related and nonasthma-related serious adverse events (SAE)s and adverse events (AE)s resulting in discontinuation (DAE)s. The primary efficacy variable was time to first asthma exacerbation. The incidences of AEs, SAEs and DAEs arising from SAEs were not significantly different between treatments. DAEs for nonserious AEs were higher with formoterol. Asthma-related AEs decreased with formoterol (1,098 (12.3%) versus 1,206 (13.5%)), asthma-related SAEs were similar (108 (1.2%) versus 121 (1.4%)) but more asthma-related DAEs occurred in the formoterol group (89 (1.0%) versus 48 (0.5%)). Time to first exacerbation was prolonged (hazard ratio 0.86) and less as-needed and maintenance medication was used with formoterol. Reductions of exacerbations with as-needed formoterol versus salbutamol increased with increasing age and asthma medication level. This real-life study demonstrates that formoterol as-needed has a similar safety profile to salbutamol, and its use as a reliever therapy is associated with fewer asthma symptoms and exacerbations.