Aclidinium bromide for the treatment of chronic obstructive pulmonary disease.
Author(s): Stone LE(1), Skelley JW, Kyle JA, Elmore LK.
Affiliation(s): Author information:
(1)Lowell E. Stone, Pharm.D., is Postgraduate Year 1 Community Pharmacy Practice
Resident; Jessica W. Skelley, Pharm.D., is Assistant Professor of Pharmacy
Practice, Department of Pharmacy Practice; Jeffrey A. Kyle, Pharm.D., BCPS, is
Associate Professor of Pharmacy Practice, Department of Pharmacy Practice; and
Lindsey K. Elmore, Pharm.D., BCPS, is Assistant Professor of Pharmacy Practice,
Department of Pharmacy Practice, McWhorter School of Pharmacy, Samford
University, Birmingham, AL.
Publication date & source: 2014, Am J Health Syst Pharm. , 71(5):386-93
PURPOSE: The safety and efficacy of the second U.S.-approved long-acting inhaled
anticholinergic for controlling bronchospasm in patients with chronic obstructive
pulmonary disease (COPD) are reviewed.
SUMMARY: Aclidinium bromide (Tudorza, Forest Pharmaceuticals) is indicated for
long-term maintenance therapy for COPD-associated bronchospasm. It is marketed as
a 60-dose metered-dose inhaler to be used twice daily. In Phase II and III
clinical trials involving a total of more than 3000 patients, daily use of
aclidinium bromide was found to significantly improve selected key indicators of
lung function (trough values for forced expiratory volume at one second [FEV1]
and other FEV1 outcome measures) compared with placebo use. Other benefits of
aclidinium bromide therapy, including a significant reduction in nighttime COPD
symptoms, were demonstrated for up to one year. However, aclidinium bromide has
not been consistently demonstrated to be more effective than the other currently
available long-acting inhaled anticholinergic, tiotropium bromide. Furthermore,
the clinical trials indicated no significant difference between aclidinium
bromide and tiotropium bromide with regard to rates of systemic adverse effects.
For some patients, aclidinium bromide may offer advantages over tiotropium
bromide (e.g., a faster time to peak FEV1, lower cost of therapy).
CONCLUSION: Aclidinium bromide is an inhaled anticholinergic that improves lung
function measures in patients with COPD. The most common adverse effects during
clinical trials of the drug were headache, nasopharyngitis, and cough, none of
which occurred at significantly higher rates than were seen with placebo use.
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