Dual bronchodilation vs triple therapy in the “real-life” COPD DACCORD study

Abstract

Background

No observational studies have evaluated the “real-world” effectiveness of dual bronchodilation comprising a long-acting β₂-agonist plus a long-acting muscarinic antagonist vs that of triple therapy (long-acting β₂-agonist plus long-acting muscarinic antagonist plus inhaled corticosteroid) in COPD.

Materials and methods

DACCORD is a non-interventional, observational clinical study that recruited patients following COPD maintenance therapy initiation or change in maintenance therapy between or within therapeutic class. Given the non-interventional nature of the study, the decision to initiate or change medication had to be made by the patients’ physicians prior to inclusion in DACCORD. We used a matched-pairs analysis to compare disease progression in two patient groups: those receiving dual bronchodilation vs those receiving triple therapy (each group n=1,046).

Results

In two subgroups of patients matched according to a broad range of demographic and disease characteristics, over 1 year, fewer patients receiving dual bronchodilation exacerbated than those receiving triple therapy (15.5% vs 26.6%; P<0.001), with a greater improvement from baseline in COPD Assessment Test total score at 1 year (mean±SD −2.9±5.8 vs −1.4±5.5;P<0.001). When analyzed according to prior therapy, the highest rate of exacerbations was in patients on triple therapy prior to the study who remained on triple therapy. Those changing from mono-bronchodilator to dual bronchodilation had the greatest COPD Assessment Test total score improvement.

Conclusion

In this “real-life” cohort of patients with COPD, most of whom had not exacerbated in the 6 months prior to entry, triple therapy did not seem to improve outcomes compared with dual bronchodilation in terms of either exacerbations or health status. Our analyses clearly demonstrate the potential impact of prior medication on study results, something that should be taken into account when interpreting the results even of controlled clinical trials.

Keywords:

• acute exacerbations of COPD
• bronchodilator
• COPD
• COPD course and therapy
• health-related quality of life

Supplementary material

Table S1 Baseline demographics and disease characteristics of patients, overall and in the matched-pairs analysis

Acknowledgments

The authors would like to thank the investigators and patients at the investigative sites for their support of this study. Writing support was provided by David Young of Young Medical Communications and Consulting Ltd. This support was funded by Novartis Pharma GmbH. This study was funded by Novartis Pharma GmbH. Employees of the sponsor were involved in study design, data analysis, and interpretation, and oversaw the conduct of the study, and (as authors) contributed to the development of this manuscript.

Disclosure

Dr Buhl reports personal fees from AstraZeneca, Chiesi, Teva, and Cipla, grants and personal fees from Boehringer Ingelheim, Novartis, and Roche, and grants from GlaxoSmithKline, all of which are outside the submitted work. Dr Criée reports personal fees from Chiesi, Boehringer Ingelheim, Novartis, Menarini, and Takeda, all of which are outside the submitted work. Dr Kardos reports personal fees from Novartis, AstraZeneca, Boehringer Ingelheim, Chiesi, GSK, Menarini, and Takeda, all of which are outside the submitted work. Dr Vogelmeier reports personal fees from Almirall, Cipla, Berlin Chemie/Menarini, CSL Behring, and Teva, grants and personal fees from AstraZeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, Grifols, Mundipharma, Novartis, and Takeda, and grants from the German Federal Ministry of Education and Research (BMBF) Competence Network Asthma and COPD (ASCONET), Bayer Schering Pharma AG, MSD, and Pfizer, all of which are outside the submitted work. Dr Kostikas is employed by, and is a stockholder in Novartis, the sponsor of the study. Outside the submitted work, he reports personal fees from Astra Zeneca, Boehringer Ingelheim, Chiesi, ELPEN, Novartis, and Takeda. Dr Lossi is employed by Novartis, the sponsor of the study. Dr Worth reports personal fees from AstraZeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, Klosterfrau, Menarini, Novartis, and Takeda, all of which are outside the submitted work. The authors report no other conflicts of interest in this work.