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      Clinical use of aclidinium in patients with COPD

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          Abstract

          Chronic obstructive pulmonary disease (COPD) is the sixth-leading cause of death in the US. The Global initiative for Chronic Obstructive Lung Disease (GOLD) guidelines provide evidence-based recommendations for the clinical management of chronic COPD. Long-acting inhaled bronchodilators continue to be the mainstay of current management. Aclidinium bromide (Tudorza™ Pressair™) joins tiotropium as a long-acting inhaled antimuscarinic bronchodilator approved by the US Food and Drug Administration for the maintenance treatment of COPD. Early studies demonstrated aclidinium’s significant bronchodilatory effects supporting once-daily dosing; however, two Phase III studies, Aclidinium Clinical Trial Assessing Efficacy and Safety in Moderate to Severe COPD Patients (ACCLAIM/COPD) I and ACCLAIM/COPD II, in which patients were randomized to receive aclidinium 200 μg daily, failed to achieve the minimal clinically important difference in improvement of trough forced expiratory volume in 1 second (FEV 1), suggesting the need for higher doses or more frequent dosing. Additional studies – Aclidinium to Treat Airway Obstruction in COPD Patients (ATTAIN) and Aclidinium in Chronic Obstructive Respiratory Disease (ACCORD) I – were undertaken to compare 200 and 400 μg twice-daily dosing. The mean improvements from baseline in trough FEV 1 in the 400 μg groups were +129 mL over 24 weeks and +124 mL over 12 weeks in ATTAIN and ACCORD I, respectively. Aclidinium also had beneficial effects on health-related quality of life and other endpoints, such as rescue medication use and rates of exacerbations. Aclidinium bromide inhalation powder is generally well tolerated in patients with COPD, with headache, cough, diarrhea, and rhinosinusitis among the most commonly reported adverse events. Cardiovascular side effects were rarely reported. Patient satisfaction studies found that patients using the aclidinium delivery device had fewer errors affecting drug delivery than those using the tiotropium device and, overall, the aclidinium device was preferred to the tiotropium device. In conclusion, aclidinium bromide is approved for use in the US at a dose of 400 μg twice daily and is a promising alternative to tiotropium.

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          Most cited references 31

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          Adherence to long-term therapies: evidence for action.

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            Epidemiology and costs of chronic obstructive pulmonary disease.

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              St. George's Respiratory Questionnaire: MCID.

              The SGRQ is a disease-specific measure of health status for use in COPD. A number of methods have been used for estimating its minimum clinically important difference (MCID). These include both expert and patient preference-based estimates. Anchor-based methods have also been used. The calculated MCID from those studies was consistently around 4 units, regardless of assessment method. By contrast, the MCID calculated using distribution-based methods varied across studies and permitted no consistent estimate. All measurements of clinical significance contain sample and measurement error. They also require value judgements, if not about the calculation of the MCID itself then about the anchors used to estimate it. Under these circumstances, greater weight should be placed upon the overall body of evidence for an MCID, rather than one single method. For that reason, estimates of MCID should be used as indicative values. Methods of analysing clinical trial results should reflect this, and use appropriate statistical tests for comparison with the MCID. Treatments for COPD that produced an improvement in SGRQ of the order of 4 units in clinical trials have subsequently found wide acceptance once in clinical practice, so it seems reasonable to expect any new treatment proposed for COPD to produce an advantage over placebo that is not significantly inferior to a 4-unit difference.
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                Author and article information

                Journal
                Int J Chron Obstruct Pulmon Dis
                Int J Chron Obstruct Pulmon Dis
                International Journal of COPD
                International Journal of Chronic Obstructive Pulmonary Disease
                Dove Medical Press
                1176-9106
                1178-2005
                2014
                28 April 2014
                : 9
                : 369-379
                Affiliations
                Department of Pharmacy Practice, Northeastern University, School of Pharmacy, Boston, MA, USA
                Author notes
                Correspondence: Debra J Reid, Department of Pharmacy Practice, Northeastern University, 360 Huntington Avenue, R218TF, Boston, MA 02115, USA, Tel +1 617 373 7719, Fax +1 617 373 7655, Email d.reid@ 123456neu.edu
                Article
                copd-9-369
                10.2147/COPD.S40193
                4010633
                24812502
                © 2014 Reid and Carlson. This work is published by Dove Medical Press Limited, and licensed under Creative Commons Attribution – Non Commercial (unported, v3.0) License

                The full terms of the License are available at http://creativecommons.org/licenses/by-nc/3.0/. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed.

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