The relationship between combination inhaled corticosteroid and long-acting β-agonist use and severe asthma exacerbations in a diverse population

Wells, Karen; Peterson, Edward L.; Ahmedani, Brian K.; Severson, Richard K.; Gleason-Comstock, Julie; Williams, L. Keoki

doi:10.1016/j.jaci.2011.12.974

Cited by 42 publications

(23 citation statements)

References 34 publications

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“…BROWN et al [30] treated 741 black patients for 1 year with budesonide/formoterol versus budesonide, and found a decreased exacerbation rate with budesonide/formoterol and a similar safety profile between the two treatments. In a real-life setting, WELLS et al [31] reviewed data from a large health maintenance organisation, including 668 African-Americans, and reported better outcomes (fewer severe exacerbations) with ICS/LABA (dominantly fluticasone/salmeterol) compared with ICS alone, with no safety issues identified.…”

Section: Discussionmentioning

confidence: 99%

Safety of formoterol in asthma clinical trials: an update

Sears

Radner

2013

Eur Respir J

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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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Section: Discussionmentioning

confidence: 99%

Safety of formoterol in asthma clinical trials: an update

Sears

Radner

2013

Eur Respir J

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“…The guidelines also indicate that combination ICS and LABA therapy be considered for individuals with this level of asthma severity. However, these recommendations are tempered by conflicting findings in the literature, which suggest both a beneficial (34,35) and detrimental effect (36) of supplemental LABA use, particularly among African American individuals. As a sensitivity analysis in a subset of SAPPHIRE participants with longitudinal prescription information, we found that self-reported African American raceethnicity was still a risk factor for nocturnal symptoms even after accounting for LABA and ICS use.…”

Section: Nocturnal Asthma Rates Between Africanmentioning

confidence: 99%

Nocturnal Asthma and the Importance of Race/Ethnicity and Genetic Ancestry

Levin

Wang

Wells³

et al. 2014

Am J Respir Crit Care Med

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Rationale: Nocturnal asthma is a common presentation and is associated with a more severe form of the disease. However, there are few epidemiologic studies of nocturnal asthma, particularly in minority populations.Objectives: To identify factors associated with nocturnal asthma, including the contribution of self-identified race/ethnicity and genetic ancestry.Methods: The analysis included individuals from the Study for Asthma Phenotypes and Pharmacogenomic Interactions by Race-ethnicity (SAPPHIRE) cohort. Nocturnal asthma symptoms were assessed by questionnaire. Genome-wide genotype data were used to estimate genetic ancestry in a subset of African American participants. Logistic regression was used evaluate the association of various factors with nocturnal asthma, such as self-identified race/ethnicity and genetic ancestry. Measurement and Main Results:The study comprised 3,380 African American and 1,818 European Americans individuals with asthma. After adjusting for other potential explanatory variables, including controller medication use, African Americans were more than twice as likely (odds ratio, 2.56; 95% confidence interval, 2.24-2.93) to report nocturnal asthma when compared with European American individuals. Among the subset of African American participants with genome-wide genotype data (n = 1,040), estimated proportion of African ancestry was also associated with an increased risk of nocturnal asthma (P = 0.007). Differences in lung function explained a small, but statistically significant (P = 0.02), proportion of the relationship between genetic ancestry and nocturnal asthma symptoms.Conclusions: Both self-identified race/ethnicity and African ancestry appear to be independent predictors of nocturnal asthma. The mechanism by which genetic ancestry contributes to populationlevel differences in nocturnal asthma appears to be largely independent of lung function.

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“…Wells and colleagues 25 estimated the effect of ICS therapy and fixed-dose ICS/LABA combination therapy on severe asthma exacerbations in a racially diverse population through database modeling: 1,828 subjects met the inclusion criteria, 37% were African-American, 46% were treated with ICS therapy alone, and 54% were treated with an ICS/LABA combination. The modeling demonstrated that treatment with ICS/LABA fixed-dose combination therapy appeared to perform as well as or better than ICS treatment alone in reducing severe asthma exacerbations, including multiple high-risk subgroups.…”

Section: Pharmacologymentioning

confidence: 99%

Respiratory Care Year in Review 2012: Asthma and Sleep-Disordered Breathing

2013

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Asthma has long been recognized as a common respiratory disease, and the recognition of sleepdisordered breathing is becoming more prevalent. Patients with these disorders are commonly seen by clinicians caring for patients with respiratory disease. There is also much academic interest in asthma and sleep-disordered breathing. The purpose of this paper is to review the recent literature related to asthma and sleep-disordered breathing in a manner that is most likely to have interest to the readers of RESPIRATORY CARE.

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The relationship between combination inhaled corticosteroid and long-acting β-agonist use and severe asthma exacerbations in a diverse population

Cited by 42 publications

References 34 publications

Safety of formoterol in asthma clinical trials: an update

Safety of formoterol in asthma clinical trials: an update

Nocturnal Asthma and the Importance of Race/Ethnicity and Genetic Ancestry

Respiratory Care Year in Review 2012: Asthma and Sleep-Disordered Breathing

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