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Regular treatment with formoterol for chronic asthma: serious adverse events

Cates, CJ; Cates, MJ (2012) Regular treatment with formoterol for chronic asthma: serious adverse events. COCHRANE DATABASE OF SYSTEMATIC REVIEWS (4). pp. 1-104. ISSN 1469-493X https://doi.org/10.1002/14651858.CD006923.pub3
SGUL Authors: Cates, Christopher Joseph

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Abstract

Epidemiological evidence has suggested a link between beta(2)-agonists and increases in asthma mortality. There has been much debate about possible causal links for this association, and whether regular (daily) long-acting beta2-agonists are safe.ObjectivesThe aim of this review is to assess the risk of fatal and non-fatal serious adverse events in trials that randomised patients with chronic asthma to regular formoterol versus placebo or regular short-acting beta2-agonists.Search methodsWe identified trials using the Cochrane Airways Group Specialised Register of trials. We checked websites of clinical trial registers for unpublished trial data and Food and Drug Administration (FDA) submissions in relation to formoterol. The date of the most recent search was January 2012.Selection criteriaWe included controlled, parallel design clinical trials on patients of any age and severity of asthma if they randomised patients to treatment with regular formoterol and were of at least 12 weeks' duration. Concomitant use of inhaled corticosteroids was allowed, as long as this was not part of the randomised treatment regimen.Data collection and analysisTwo authors independently selected trials for inclusion in the review. One author extracted outcome data and the second author checked them. We sought unpublished data on mortality and serious adverse events.Main resultsThe review includes 22 studies (8032 participants) comparing regular formoterol to placebo and salbutamol. Non-fatal serious adverse event data could be obtained for all participants from published studies comparing formoterol and placebo but only 80% of those comparing formoterol with salbutamol or terbutaline.Three deaths occurred on regular formoterol and none on placebo; this difference was not statistically significant. It was not possible to assess disease-specific mortality in view of the small number of deaths. Non-fatal serious adverse events were significantly increased when regular formoterol was compared with placebo (Peto odds ratio (OR) 1.57; 95% CI 1.06 to 2.31). One extra serious adverse event occurred over 16 weeks for every 149 people treated with regular formoterol (95% CI 66 to 1407 people). The increase was larger in children than in adults, but the impact of age was not statistically significant. Data submitted to the FDA indicate that the increase in asthma-related serious adverse events remained significant in patients taking regular formoterol who were also on inhaled corticosteroids.No significant increase in fatal or non-fatal serious adverse events was found when regular formoterol was compared with regular salbutamol or terbutaline.Authors' conclusionsIn comparison with placebo, we have found an increased risk of serious adverse events with regular formoterol, and this does not appear to be abolished in patients taking inhaled corticosteroids. The effect on serious adverse events of regular formoterol in children was greater than the effect in adults, but the difference between age groups was not significant.Data on all-cause serious adverse events should be more fully reported in journal articles, and not combined with all severities of adverse events or limited to those events that are thought by the investigator to be drug-related.

Item Type: Article
Additional Information: This review is published as a Cochrane Review in the Cochrane Database of Systematic Reviews 2012, Issue 4. Cochrane Reviews are regularly updated as new evidence emerges and in response to comments and criticisms, and the Cochrane Database of Systematic Reviews should be consulted for the most recent version of the Review. Cates CJ, Cates MJ. Regular treatment with formoterol for chronic asthma: serious adverse events. Cochrane Database of Systematic Reviews 2012, Issue 4. Art. No.: CD006923. DOI: 10.1002/14651858.CD006923.pub3.
Keywords: Science & Technology, Life Sciences & Biomedicine, Medicine, General & Internal, General & Internal Medicine, Adrenergic beta-Agonists [adverse effects], Age Factors, Albuterol [adverse effects], Asthma [drug therapy; mortality], Bronchodilator Agents [adverse effects], Chronic Disease, Ethanolamines [adverse effects], Adult, Child, Humans, DRY POWDER INHALER, EXERCISE-INDUCED BRONCHOCONSTRICTION, METERED-DOSE INHALER, LONG-ACTING BETA(2)-AGONISTS, MODERATE-PERSISTENT ASTHMA, QUALITY-OF-LIFE, OBSTRUCTIVE AIRWAY DISEASE, ON-DEMAND SALBUTAMOL, DOUBLE-BLIND, BRONCHIAL-ASTHMA, Adrenergic beta-Agonists [adverse effects], Age Factors, Albuterol [adverse effects], Asthma [drug therapy; mortality], Bronchodilator Agents [adverse effects], Chronic Disease, Ethanolamines [adverse effects], Adult, Child, Humans
SGUL Research Institute / Research Centre: Academic Structure > Population Health Research Institute (INPH)
Journal or Publication Title: COCHRANE DATABASE OF SYSTEMATIC REVIEWS
ISSN: 1469-493X
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Dates:
DateEvent
January 2012Published
Web of Science ID: WOS:000303012500036
URI: https://openaccess.sgul.ac.uk/id/eprint/2675
Publisher's version: https://doi.org/10.1002/14651858.CD006923.pub3

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