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, Randall W.; O’Brien, Christopher; Martin, Ubaldo J.; Uryniak, Tom; Lampl, Kathy

doi:10.1016/j.jaci.2012.03.028

Cited by 18 publications

(7 citation statements)

References 27 publications

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“…The efficacy of the SMART regimen observed in Māori may apply to other at risk populations defined by ethnicity that have a disproportionate burden of disease. [8][9][10][11] The efficacy of budesonide/formoterol in a fixed-dose regimen has been demonstrated in African American asthma patients, 28 and our study extends these findings to the use of budesonide/formoterol as maintenance and reliever therapy in another at risk ethnic group. Differences in response to LABA therapy by ethnicity have been suggested in African Americans 29 highlighting the importance of investigation into the impact of ethnicity on both individual and population-level outcomes in clinical trials.…”

Section: Discussionsupporting

confidence: 69%

Combination budesonide/formoterol inhaler as maintenance and reliever therapy in Māori with asthma

Pilcher

Patel

Smith³

et al. 2014

Respirology

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Section: Discussionsupporting

confidence: 69%

Combination budesonide/formoterol inhaler as maintenance and reliever therapy in Māori with asthma

Pilcher

Patel

Smith³

et al. 2014

Respirology

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“…SPECTOR et al [29] treated 311 black patients with budesonide/formoterol versus budesonide, and reported increased benefit in lung function and asthma control with similar safety profiles. 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

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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“…This warning is listed both for LABA alone and for when combined with ICS. A study by Brown and colleagues 26 assessed safety and asthma control within budesonide/formoterol pressurized metered-dose inhaler versus the budesonide over a 1-year period in an African-American population. The study was in subjects Ն 12 years of age with moderate to severe asthma previously receiving medium to high-dose ICS.…”

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

Cited by 18 publications

References 27 publications

Combination budesonide/formoterol inhaler as maintenance and reliever therapy in Māori with asthma

Combination budesonide/formoterol inhaler as maintenance and reliever therapy in Māori with asthma

Safety of formoterol in asthma clinical trials: an update

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

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