Extract
A publication by Zhou et al. [1], who studied 841 patients from China with mild to moderate chronic obstructive pulmonary disease (COPD) (Global Initiative for Chronic Obstructive Lung Disease (GOLD) stage I and II) for 2 years, documented a 22 mL per year beneficial effect of tiotropium compared with placebo on rate of forced expiratory volume in 1 s (FEV1). This effect was over three times larger than the 6 mL per year (95% CI 1 to 11 mL per year) reported by Decramer et al. [2] in the 2739 GOLD stage II patients from the 4-year UPLIFT trial. We hypothesised that the large difference in results in patients with COPD with similar degree of airflow limitation at study entry could be related to regional differences in response to similar pharmacological treatment. To test this hypothesis, we investigated the regional differences in FEV1 decline in patients in the COPD Study to Understand Mortality and MorbidITy (SUMMIT), all of whom had spirometric GOLD stage II COPD at enrolment [3].
Abstract
This analysis of FEV1 decline in patients who enrolled with spirometric GOLD stage II COPD (SUMMIT) showed regional differences in therapeutic response. Such variation should be considered when comparing pharmacotherapies across different global areas. http://bit.ly/2YwMIgW
Footnotes
Support statement: The SUMMIT study (GSK study number 113782; NCT01313676) was funded by GSK. Funding information for this article has been deposited with the Crossref Funder Registry.
Conflict of interest: B.R. Celli reports grants from AstraZeneca, personal fees for consultancy from GlaxoSmithKline, Boehringer Ingelheim, AstraZeneca and Novartis, personal fees for travel from GlaxoSmithKline, personal fees for participating in review activities from GlaxoSmithKline, during the conduct of the study; personal fees for consultancy from Boehringer Ingelheim, AstraZeneca, Almirall and Novartis, outside the submitted work.
Conflict of interest: J.A. Anderson is an employee of and owns shares in GSK.
Conflict of interest: R.D. Brook reports personal fees for steering committee work from GSK, during the conduct of the study.
Conflict of interest: P.M.A. Calverley has advised Boehringer Ingelheim, GSK, AstraZeneca and Takeda on the design and conduct of clinical trials and has spoken at meetings sponsored by these companies and by Novartis. He has no stock holdings in any pharmaceutical company or connection with the tobacco industry.
Conflict of interest: N.J. Cowans is employed by Veramed Ltd, a contract research organisation undertaking contracted statistical analyses of respiratory studies funded by GSK.
Conflict of interest: C. Crim is an employee of and owns shares in GSK.
Conflict of interest: F. Martinez reports non-financial support from GSK as sponsor of the parent study; personal fees for organising education from Continuing Education, CME Incite, Annenberg Center for Health Sciences at Eisenhower, Integritas, Paradigm Medical Communications, LLC, PeerVoice, UpToDate, Haymarket Communications, Western Society of Allergy and Immunology, Methodist Hospital, Columbia University, Prime Healthcare Ltd, WebMD, PeerView Network, California Society of Allergy and Immunology, National Association for Continuing Education, Chiesi and Puerto Rico Thoracic Society, personal fees for steering committee work from Forest Laboratories, has participating on an advisory board for Janssen, personal fees for steering committee, data and safety monitoring board and advisory board work, and lecturing from GlaxoSmithKline, personal fees for steering committee and advisory board work, and organising education from Nycomed/Takeda, personal fees for steering committee and advisory board work, and lecturing from AstraZeneca and Boehringer Ingelheim, personal fees for advisory board work from Bellerophon (formerly Ikaria), Genentech, Roche, Sunovion, Theravance and ConCert Pharmaceuticals, personal fees for advisory board work and organising education from Novartis, personal fees for steering committee and advisory board work from Pearl, personal fees for consultancy from InThought, Proterixbio (formerly Bioscale), Unity Biotechnology and Lucid, outside the submitted work.
Conflict of interest: D.E. Newby reports grants and personal fees for steering committee work from GSK, during the conduct of the study.
Conflict of interest: J. Yates is an employee of and owns shares in GSK.
Conflict of interest: J. Vestbo reports personal fees for steering committee work from GlaxoSmithKline, during the conduct of the study; personal fees from for consultancy and lecturing from GlaxoSmithKline, Chiesi Pharmaceuticals, Boehringer Ingelheim, Novartis and AstraZeneca, outside the submitted work.
The SUMMIT trial is a registered clinical trial (NCT01313676). Information on GSK's data sharing commitments and requesting access to anonymised individual participant data and associated documents can be found at www.clinicalstudydatarequest.com
- Received February 8, 2019.
- Accepted March 3, 2019.
- Copyright ©ERS 2019
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