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2016-05-09

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cc-by-nc (c) Wedzicha et al., 2016
Please use this identifier to cite or link to this item: https://hdl.handle.net/2445/109426

Effect of aclidinium bromide on exacerbations in patients with moderate to severe COPD: a pooled analysis of five Phase III, randomized, placebo-controlled studies

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https://doi.org/10.3109/15412555.2016.1170111

Abstract

We investigated the effect of the long-acting muscarinic antagonist aclidinium bromide on chronic obstructive pulmonary disease (COPD) exacerbations by pooling data from five randomized, placebo-controlled,parallel-group Phase III studies of 3-6 months' duration. Data were pooled from the aclidinium 400 μg twice-daily (BID) and placebo arms (N = 2,521) and stratified by Global initiative for chronic Obstructive Lung Disease (GOLD) group (A, B, C and D). Results showed that fewer patients experienced 1 exacerbation with aclidinium (any severity: 12.5%; moderate to severe: 10.9%) compared with placebo (any severity: 15.7%; moderate to severe: 13.3%) and the odds of experiencing 1 exacerbation of any severity were reduced in patients receiving aclidinium (odds ratio = 0.78, p = 0.039). Furthermore, aclidinium reduced the rate of exacerbations compared with placebo (any severity: rate ratio = 0.79, p = 0.026; moderate to severe: 0.80, p = 0.044). The time to first exacerbation of any severity was delayed with aclidinium compared with placebo (hazard ratio = 0.79, p = 0.026) and there was a numerical delay in time to first moderate-to-severe exacerbation. Finally, the effects of aclidinium on exacerbations versus placebo were greater in patients in GOLD Groups B and D; however, it is of note that only 10.7% of patients were classified in Group A or C. In summary, the results indicate that aclidinium 400 μg BID reduces the frequency of COPD exacerbations compared with placebo and that these effects are greater in symptomatic patients.

Subject

Malalties pulmonars obstructives cròniques, Malalties del pulmó

Subject (English)

Chronic obstructive pulmonary diseases, Pulmonary diseases

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Articles publicats en revistes (Medicina)
Articles publicats en revistes (IDIBAPS: Institut d'investigacions Biomèdiques August Pi i Sunyer)

Citation

WEDZICHA, Jadwiga A., et al. Effect of aclidinium bromide on exacerbations in patients with moderate to severe COPD: a pooled analysis of five Phase III, randomized, placebo-controlled studies. International Journal of Chronic Obstructive Pulmonary Disease. 2016. Vol. 13, num. 6, pags. 669-676. ISSN 1176-9106. [consulted: 11 of August of 2026]. Available at: https://hdl.handle.net/2445/109426

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