Abstract
Aclidinium, an inhaled, long-acting antimuscarinic agent, has been developed as a twice-daily maintenance treatment for chronic obstructive pulmonary disease (COPD).
Treatment with the approved dosage of aclidinium (400 μg twice daily) statistically significantly improved bronchodilation, disease-specific health status, dyspnoea, night-time COPD symptoms and use of rescue medication compared with placebo in pivotal studies of 12 (ACCORD COPD I) or 24 (ATTAIN) weeks duration in patients with moderate to severe COPD.
The improvements in bronchodilation, health status and dyspnoea were clinically meaningful compared with placebo after 24 weeks of treatment in ATTAIN; generally similar results were seen after 12 weeks of treatment in both trials.
Aclidinium also statistically significantly reduced the incidence of COPD exacerbations compared with placebo in these studies (albeit neither trial was designed to assess exacerbation frequency).
Inhaled aclidinium has a low systemic bioavailability; the approved dosage was generally well tolerated in clinical trials of up to 52 weeks duration.
Aclidinium had an adverse event profile that was similar to that of placebo and characterized by low incidences of major adverse cardiovascular events and potential anticholinergic adverse events.
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Acknowledgements and Disclosures
The manuscript was reviewed by M. Cazzola, Division of Respiratory Diseases, Department of Internal Medicine, University of Rome, Rome, Italy; A.D. D’ Urzo, Department of Family and Community Medicine, University of Toronto, Toronto, ON, Canada; H. Magnussen, Pulmonary Research Institute at Hospital Grosshansdorf, Center for Pneumology and Thoracic Surgery, Grosshansdorf, Germany.
The preparation of this review was not supported by any external funding. During the peer review process, the manufacturer of the agent under review was offered an opportunity to comment on this article. Changes resulting from comments received were made by the author on the basis of scientific and editorial merit.
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Frampton, J.E. Aclidinium. Drugs 72, 1999–2011 (2012). https://doi.org/10.2165/11209700-000000000-00000
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DOI: https://doi.org/10.2165/11209700-000000000-00000