Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2016 Mar;33(3):379-99.
doi: 10.1007/s12325-016-0299-4. Epub 2016 Feb 16.

Efficacy and Safety of Aclidinium/Formoterol versus Tiotropium in COPD: Results of an Indirect Treatment Comparison

Goran Medic  1 , Leandro Lindner  2 , Miriam van der Weijden  3 , Andreas Karabis  1
Affiliations

Efficacy and Safety of Aclidinium/Formoterol versus Tiotropium in COPD: Results of an Indirect Treatment Comparison

Goran Medic et al. Adv Ther. 2016 Mar.

Abstract

Introduction: The objective of this study was to estimate the relative efficacy and safety of fixed-dose combination aclidinium/formoterol 400/12 μg twice daily compared to tiotropium 18 μg once daily in adult patients with moderate-to-severe chronic obstructive pulmonary disease (COPD).

Methods: A systematic literature review performed in March 2014, using a predefined search strategy in MEDLINE, EMBASE and Cochrane Library, identified 17 randomized placebo-controlled trials, (tiotropium n = 15; aclidinium/formoterol n = 2). Outcomes of interest were: bronchodilation (peak and trough forced expiratory volume in 1 s (FEV1)), COPD symptoms [Transition Dyspnea Index (TDI) focal score and % of responders (>1 unit improvement)] and Health Related Quality of Life (HRQoL) [St. George's Respiratory Questionnaire (SGRQ) total score and % responders (>4 unit improvement)], % of patients with ≥1 exacerbations, adverse events (AE), serious adverse events (SAE), hospitalization and mortality, all at 24 weeks. In the absence of head-to-head trials between aclidinium/formoterol and tiotropium, a Bayesian indirect treatment comparison (ITC) was used with placebo as common control.

Results: Regarding bronchodilation, aclidinium/formoterol was found to be more efficacious than tiotropium at peak FEV1, with mean difference in change from baseline (DCFB) 143 mL [95% credible interval (CrI): 112, 174] and at trough FEV1 [DCFB 26 mL (95% CrI -2, 55)]. Aclidinium/formoterol is expected to be more efficacious than tiotropium in improving dyspnea symptoms measured by TDI [DCFB 0.54 points (95% CrI 0.09, 0.99); odds ratio (OR) of responders 1.51 (95% CrI 1.11, 2.06)]. SGRQ results are comparable for aclidinium/formoterol versus tiotropium [DCFB -0.52 (95% CrI -2.21, 1.17); OR of responders 1.16 (95% CrI 0.47, 2.87)]. The ITC results suggest similar safety profiles regarding AEs, SAEs and hospitalization.

Conclusion: Based on the ITC, aclidinium/formoterol is expected to be more efficacious than tiotropium in terms of lung function and symptom control while providing comparable HRQoL results and safety profile.

Funding: AstraZeneca.

Keywords: Aclidinium; Formoterol; Indirect treatment comparison; Literature review; Tiotropium.

PubMed Disclaimer

Figures

Fig. 1
Fig. 1
Flowchart of the study selection process. ATS American Thoracic Society, CSR clinical study report, ERS European Respiratory Society
Fig. 2
Fig. 2
Network of studies included in the indirect treatment comparison
See this image and copyright information in PMC

References

    1. Bhowmik A, Seemungal TA, Sapsford RJ, Wedzicha JA. Relation of sputum inflammatory markers to symptoms and lung function changes in COPD exacerbations. Thorax. 2000;55(2):114–120. doi: 10.1136/thorax.55.2.114. - DOI - PMC - PubMed
    1. World Health Organization: World Health Statistics. Geneva. 2008. http://www.who.int/gho/publications/world_health_statistics/EN_WHS08_Ful.... 2008.
    1. Chapman KR, Mannino DM, Soriano JB, Vermeire PA, Buist AS, Thun MJ, et al. Epidemiology and costs of chronic obstructive pulmonary disease. Eur Respir J. 2006;27(1):188–207. doi: 10.1183/09031936.06.00024505. - DOI - PubMed
    1. National Institutes of Health. National Heart, Lung and Blood Institute. Morbidity and Mortality: 2012 chart book on cardiovascular, lung, and blood diseases. Bethesda, MD. https://www.nhlbi.nih.gov/files/docs/research/2012_ChartBook_508.pdf. 2012.
    1. Global Initiative for Chronic Obstructive Lung Disease (GOLD). Global strategy for the diagnosis, management, and prevention of COPD. http://www.goldcopd.org/uploads/users/files/GOLD_Report_2015.pdf. 2015.

Publication types

MeSH terms

LinkOut - more resources