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1 Dept of Respiratory Diseases, Ghent University Hospital, Ghent, Belgium, 2 Firestone Institute for Respiratory Health, St. Joseph's Healthcare and McMaster University, Hamilton, Canada, 3 Dept of General Practice, University of Glasgow, Glasgow, UK, 4 Dept ofRespiratory Diseases, Hospital Universitario LaPaz, Madrid, Spain, 5 Pulmonary Dept, Rui Jin Hospital, Shanghai Second Medical University, Shanghai, China, 6 Husläkarna Österåker, Åkersberga, Sweden, 7 Dept of Internal Medicine, Brüderkrankenhaus, Paderborn, Germany, 8 Dept of Pneumology, Hôpital Bichat Claude Bernard, Paris, France, and 9 Clinical Development, AstraZeneca R&D Lund, Lund, Sweden
CORRESPONDENCE: R. Pauwels, Dept of Respiratory Diseases, University Hospital, De Pintelaan 185, B9000, Ghent, Belgium. Fax: 32 92402341. E-mail: Romain.Pauwels@UGent.be
Keywords: age, asthma, effectiveness, formoterol, safety, salbutamol
Received: May 19, 2003
Accepted August 7, 2003
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.
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