Regular treatment with formoterol for chronic asthma: serious adverse events

Cates, Christopher J; Cates, Matthew; Lasserson, Toby J

doi:10.1002/14651858.cd006923.pub2

Cited by 28 publications

(30 citation statements)

References 182 publications

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“…Moreover, as the mechanism has an immune basis involving the aberrant activation of STAT6, our findings further explain the ability of glucocorticosteroids when added to salmeterol to mask in part this untoward effect. Interestingly, addition of glucocorticosteroids to formoterol does not necessarily mask the pro-asthmatic potential, and thus morbidity, of this LABA [ 15 ], nor is it clear that addition of glucocorticosteroids entirely block the pro-asthmatic potential of salmeterol with long-term use [ 14 ]. Our data further support these observations because although glucocorticosteroids have a clear anti-asthmatic effect ( Fig 1C ), LABAs activate STAT6 even in the presence of glucocorticosteroids and are alone sufficient to induce asthma-like airway obstruction in the complete absence of allergen provocation ( Fig 1D and 1H ; S3 Fig ).…”

Section: Discussionmentioning

confidence: 99%

Long-Acting Beta Agonists Enhance Allergic Airway Disease

Knight

Mak

Shaw³

et al. 2015

PLoS ONE

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Asthma is one of the most common of medical illnesses and is treated in part by drugs that activate the beta-2-adrenoceptor (β2-AR) to dilate obstructed airways. Such drugs include long acting beta agonists (LABAs) that are paradoxically linked to excess asthma-related mortality. Here we show that LABAs such as salmeterol and structurally related β2-AR drugs such as formoterol and carvedilol, but not short-acting agonists (SABAs) such as albuterol, promote exaggerated asthma-like allergic airway disease and enhanced airway constriction in mice. We demonstrate that salmeterol aberrantly promotes activation of the allergic disease-related transcription factor signal transducer and activator of transcription 6 (STAT6) in multiple mouse and human cells. A novel inhibitor of STAT6, PM-242H, inhibited initiation of allergic disease induced by airway fungal challenge, reversed established allergic airway disease in mice, and blocked salmeterol-dependent enhanced allergic airway disease. Thus, structurally related β2-AR ligands aberrantly activate STAT6 and promote allergic airway disease. This untoward pharmacological property likely explains adverse outcomes observed with LABAs, which may be overcome by agents that antagonize STAT6.

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Section: Discussionmentioning

confidence: 99%

Long-Acting Beta Agonists Enhance Allergic Airway Disease

Knight

Mak

Shaw³

et al. 2015

PLoS ONE

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“…Our two previous reviews Cates 2008a) indicated an increase in all-cause SAEs when both regular formoterol and regular salmeterol were compared with placebo. It would require very large numbers of patients in head-to-head comparison trials to determine whether there is any difference in SAEs between regular formoterol and salmeterol, and it is perhaps not surprising that it has not been possible to draw conclusions from this review, as the number of participants in the included trials is relatively small.…”

Section: Agreements and Disagreements With Other Studies Or Reviewsmentioning

confidence: 93%

“…Two published reviews have assessed the risk of serious adverse events (SAEs) with regular salmeterol and formoterol (Cates 2008a) without randomised inhaled corticosteroids in comparison to placebo or short-acting beta 2 -agonists, and further reviews have compared regular formoterol and salmeterol when randomised with an inhaled corticosteroid Cates 2009a;Jaeschke 2008a).…”

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confidence: 99%

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

Cates¹,

Lasserson²

2009

Cochrane Database of Systematic Reviews

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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.

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“…Other asthmatics may benefit from vaccination, although it does not appear to protect from asthma exacerbations or improve asthma control (Evidence B). [107–109]…”

Section: Approach To Asthma Managementmentioning

confidence: 99%

The Saudi initiative for asthma - 2012 update: Guidelines for the diagnosis and management of asthma in adults and children

et al. 2012

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This an updated guidelines for the diagnosis and management of asthma, developed by the Saudi Initiative for Asthma (SINA) group, a subsidiary of the Saudi Thoracic Society. The main objective of SINA is to have updated guidelines, which are simple to understand and easy to use by non-asthma specialists, including primary care and general practice physicians. This new version includes updates of acute and chronic asthma management, with more emphasis on the use of Asthma Control Test in the management of asthma, and a new section on “difficult-to-treat asthma.” Further, the section on asthma in children was re-written to cover different aspects in this age group. The SINA panel is a group of Saudi experts with well-respected academic backgrounds and experience in the field of asthma. The guidelines are formatted based on the available evidence, local literature, and the current situation in Saudi Arabia. There was an emphasis on patient–doctor partnership in the management that also includes a self-management plan. The approach adopted by the SINA group is mainly based on disease control as it is the ultimate goal of treatment.

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Regular treatment with formoterol for chronic asthma: serious adverse events

Cited by 28 publications

References 182 publications

Long-Acting Beta Agonists Enhance Allergic Airway Disease

Long-Acting Beta Agonists Enhance Allergic Airway Disease

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

The Saudi initiative for asthma - 2012 update: Guidelines for the diagnosis and management of asthma in adults and children

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