Regular treatment with formoterol versus regular treatment with salmeterol for chronic asthma: serious adverse events

Abstract

Background-An increase in serious adverse events with both regular formoterol and regular salmeterol in chronic asthma has been demonstrated in previous Cochrane reviews. Objectives-We set out to compare the risks of mortality and non-fatal serious adverse events in trials which have randomised patients with chronic asthma to regular formoterol versus regular salmeterol. Search methods-We identified trials using the Cochrane Airways Group Specialised Register of trials. We checked manufacturers' websites of clinical trial registers for unpublished trial data and also checked Food and Drug Administration (FDA) submissions in relation to formoterol and salmeterol. The date of the most recent search was January 2012. Selection criteria-We included controlled, parallel-design clinical trials on patients of any age and with any severity of asthma if they randomised patients to treatment with regular formoterol versus regular salmeterol (without randomised inhaled corticosteroids), and were of at least 12 weeks' duration.

Long-Acting β2-Agonist Step-off in Patients With Controlled Asthma

“…2 Few new data about the safety of LABAs have been forthcoming, but investigators, including some from the FDA, have pooled data from previous clinical trials to further study the potential risks of LABAs. [57][58][59][60][61][62][63][64][65][66][67][68][69] These analyses have provided con-tradictory conclusions, putting clinicians in an unsettling role of trying to decide how to best step down therapy. Indeed, the present study was prompted by members of the American Academy of Allergy Asthma and Immunology and American Thoracic Society appealing to the leadership of these professional societies for guidance, especially in regard to how best to step down asthma treatment once asthma is controlled.…”