Safety of formoterol in patients with asthma: Combined analysis of data from double-blind, randomized controlled trials

Nelson, Harold S.; Bonuccelli, Catherine M.; Radner, Finn; Ottosson, Anders; Carroll, Kevin; Andersson, Tomas; LaForce, Craig

doi:10.1016/j.jaci.2009.11.036

Cited by 42 publications

(29 citation statements)

References 42 publications

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“…showing no evidence of an increased risk of serious asthma events when formoterol is used in conjunction with an ICS either as a fixeddose combination or as separate devices. [20][21][22] In this study budesonide/formoterol was well tolerated in African American patients, with a safety profile similar to that of budesonide alone. Across AE, clinical laboratory, and cardiac safety parameters, no substantial or unexpected abnormal patterns were observed with budesonide/formoterol or budesonide for up to 1 year of treatment.…”

Section: Discussionmentioning

confidence: 68%

Long-term safety and asthma control measures with a budesonide/formoterol pressurized metered-dose inhaler in African American asthmatic patients: A randomized controlled trial

Brown

O’Brien

Martin

et al. 2012

Journal of Allergy and Clinical Immunology

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Section: Discussionmentioning

confidence: 68%

Long-term safety and asthma control measures with a budesonide/formoterol pressurized metered-dose inhaler in African American asthmatic patients: A randomized controlled trial

Brown

O’Brien

Martin

et al. 2012

Journal of Allergy and Clinical Immunology

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“…However, the data reported in the present paper, together with the many other meta-analyses and systematic reviews of the existing literature that have been undertaken [5][6][7][8][9][10][11][12][13], are consistent with the likelihood that the problem associated with use of LABAs in asthma is not an intrinsic safety issue related to the LABA itself, but to the overall management of the condition and the lack of appropriate treatment with ICS [23,28,32]. A number of Cochrane reviews [33][34][35][36][37] have addressed the safety of LABA/ICS combinations compared to use of ICS alone, and concluded that while combination therapy in general is favourable compared to ICS-alone treatment in adults, the results are less clear in children for whom limited data are yet available.…”

Section: Discussionmentioning

confidence: 99%

“…Many questions were not readily answered because of the structure of those studies, particularly whether the outcomes related directly to adverse effects of LABA treatment or to undertreatment with anti-inflammatory medications such as inhaled corticosteroids (ICS) allowing asthma to be less well controlled despite symptomatic relief from the bronchodilator (''masking'') [4]. Numerous meta-analyses and reviews of clinical trials involving salmeterol and formoterol with and without ICS in patients with asthma have been published [5][6][7][8][9][10][11][12][13]. Although controversy has continued, there is growing consensus that use of LABAs with adequate ICS is both effective and safe [14,15].…”

Section: Introductionmentioning

confidence: 99%

Safety of formoterol in asthma clinical trials: an update

Sears

Radner

2013

European Respiratory Journal

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Use of long-acting b-agonists (LABAs) in asthma remains controversial, and large safety trials are in progress. We have previously reported safety outcomes with formoterol in 117 AstraZeneca asthma trials (78 339 patients, 92% using inhaled corticosteroids) completed by December 2006, and have now added 32 trials with formoterol (26 124 patients, 100% using inhaled corticosteroids) completed by December 2011.The primary dataset of 79 randomised controlled trials includes 94 684 patients, 67 380 of whom were exposed to formoterol, while the complete dataset comprises 149 trials and 104 463 patients. There were no new asthma-related deaths in the expanded primary dataset, with eight asthma-related deaths among formoterolrandomised patients and two among non-LABA-randomised patients (relative risk 1.13, 95% CI 0.23-10.9), and 15 versus nine cardiac-related deaths (relative risk 0.47, 95% CI 0.19-1.22). Nonfatal asthma-related serious adverse events were significantly reduced with formoterol (relative risk 0.63, 95% CI 0.53-0.75), as were discontinuations due to adverse events. Examining 40 trials with direct formoterol versus non-LABA comparisons, Mantel-Haenszel relative risk for asthma-related death was 2.75 (95% CI 0.52-14.4) and for serious adverse events 0.83 (95% CI 0.68-1.02).We conclude that this enlarged dataset indicates no increased risk of asthma-related deaths among patients exposed to formoterol compared with non-LABA treatments, although the wide confidence interval precludes certainty. @ERSpublications No increased risk of asthma-or cardiac-related deaths or serious adverse events associated with the use of formoterol http://ow.ly/qfShl For editorial comments see page 6.

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“…The FDA also mandated several large randomized, blinded studies of ICS versus ICS/LABA [31]. Analysis of more than 23,000 patients in 42 clinical trials with formoterol and non-LABA treatment arms found no increased risk for asthma-related death or hospitalization in patients using formoterol with or without ICS [32]. Substantively, the results of a recent meta-analysis showed that patients whose asthma had been well controlled by the addition of a LABA to ICS did worse when LABA was withdrawn.…”

Section: The Goals Of Asthma Treatmentmentioning

confidence: 99%

Allergic Disorders at a Venerable Age: A Mini-Review

Milgrom

Huang

2013

Gerontology

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This review focuses on 3 allergic disorders of persons coming up against venerable age: asthma, allergic rhinitis, and atopic dermatitis. The prevalence of allergic diseases in the elderly ranges from 5 to 10% and appears to be rising. A gradual decline in immune function, termed immunosenescence, and age-related changes in tissue structure influence the development of these disorders. Common complications are comorbidities, polypharmacy, and adverse effects of drugs. The elderly have difficulty mounting protective immune responses against newly encountered antigens. The integrity of epithelial barriers is compromised, leading to a chronic, subclinical inflammatory state and an enhanced Th2 (allergic) immune response. Undiagnosed asthma is frequent in elderly persons (about 8%) and still more commonplace in those with respiratory symptoms. Poorly controlled asthma in the elderly undermines their functional status and leads to a loss of autonomy and social isolation that may delay seeking medical services. Aggravation of allergic rhinitis coincides with exacerbation of asthma, whereas treatment of nasal inflammation improves control of the asthma. Atopic dermatitis is a chronically relapsing inflammatory skin disease often associated with respiratory allergy.

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Safety of formoterol in patients with asthma: Combined analysis of data from double-blind, randomized controlled trials

Cited by 42 publications

References 42 publications

Long-term safety and asthma control measures with a budesonide/formoterol pressurized metered-dose inhaler in African American asthmatic patients: A randomized controlled trial

Long-term safety and asthma control measures with a budesonide/formoterol pressurized metered-dose inhaler in African American asthmatic patients: A randomized controlled trial

Safety of formoterol in asthma clinical trials: an update

Allergic Disorders at a Venerable Age: A Mini-Review

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