Impact of pre-enrolment medication use on clinical outcomes in SUMMIT
The impact of prior treatment on results of clinical trials in chronic obstructive pulmonary disease (COPD) has been debated. We used data from the Study to Understand Mortality and Morbidity in COPD Trial to examine the impact of prior treatment on the effects of randomised study drugs on mortality...
| Main Authors: | , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
European Respiratory Society
2019-02-01
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| Series: | ERJ Open Research |
| Online Access: | http://openres.ersjournals.com/content/5/1/00203-2018.full |
| _version_ | 1819018028863455232 |
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| author | Jørgen Vestbo Mark Dransfield Julie A. Anderson Robert D. Brook Peter M.A. Calverley Bartolome R. Celli Nicholas J. Cowans Courtney Crim Fernando Martinez David E. Newby Julie Yates Peter Lange |
| author_facet | Jørgen Vestbo Mark Dransfield Julie A. Anderson Robert D. Brook Peter M.A. Calverley Bartolome R. Celli Nicholas J. Cowans Courtney Crim Fernando Martinez David E. Newby Julie Yates Peter Lange |
| author_sort | Jørgen Vestbo |
| collection | DOAJ |
| description | The impact of prior treatment on results of clinical trials in chronic obstructive pulmonary disease (COPD) has been debated. We used data from the Study to Understand Mortality and Morbidity in COPD Trial to examine the impact of prior treatment on the effects of randomised study drugs on mortality and exacerbations. We used data on 16 417 patients with moderate COPD and heightened cardiovascular risk and information on prior medications to examine the effects of fluticasone furoate (FF), vilanterol (VI) and combined FF/VI compared to placebo on moderate and severe exacerbation as well as mortality. The study was event-driven with a median study exposure of 1.8 years. This study was registered with ClinicalTrials.gov, number NCT01313676. There were no consistent associations between treatment prior to study entry and the effects of FF, VI or FF/VI on exacerbations during the study. However, patients taking inhaled corticosteroids and one or more bronchodilators prior to study entry seemed to have a better effect of active treatments than of placebo on mortality (hazard ratio for FF/VI 0.65, 95% CI 0.48–0.89). Survival in those randomised to placebo was independent of treatment prior to study enrolment. Prior treatment appears to affect treatment effects on mortality but not exacerbations in a randomised controlled trial of patients with COPD and heightened cardiovascular risk. |
| first_indexed | 2024-12-21T03:12:55Z |
| format | Article |
| id | doaj.art-b94b54ee3a0d4e2f99932787f57598df |
| institution | Directory Open Access Journal |
| issn | 2312-0541 |
| language | English |
| last_indexed | 2024-12-21T03:12:55Z |
| publishDate | 2019-02-01 |
| publisher | European Respiratory Society |
| record_format | Article |
| series | ERJ Open Research |
| spelling | doaj.art-b94b54ee3a0d4e2f99932787f57598df2022-12-21T19:17:55ZengEuropean Respiratory SocietyERJ Open Research2312-05412019-02-015110.1183/23120541.00203-201800203-2018Impact of pre-enrolment medication use on clinical outcomes in SUMMITJørgen Vestbo0Mark Dransfield1Julie A. Anderson2Robert D. Brook3Peter M.A. Calverley4Bartolome R. Celli5Nicholas J. Cowans6Courtney Crim7Fernando Martinez8David E. Newby9Julie Yates10Peter Lange11 Division of Infection, Immunity and Respiratory Medicine, School of Biological Sciences, The University of Manchester, Manchester, UK Lung Health Center, University of Alabama at Birmingham, Birmingham, AL, USA Research and Development, GlaxoSmithKline, Uxbridge, UK University of Michigan Health System, Ann Arbor, MI, USA University of Liverpool, Dept of Medicine, Clinical Sciences Centre, University Hospital Aintree, Liverpool, UK Pulmonary and Critical Care Division, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA Veramed Ltd, Twickenham, UK Research and Development, GlaxoSmithKline, Research Triangle Park, NC, USA University of Michigan Health System, Ann Arbor, MI, USA British Heart Foundation Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, UK Research and Development, GlaxoSmithKline, Research Triangle Park, NC, USA Dept of Public Health, Section of Social Medicine, University of Copenhagen, Copenhagen, Denmark The impact of prior treatment on results of clinical trials in chronic obstructive pulmonary disease (COPD) has been debated. We used data from the Study to Understand Mortality and Morbidity in COPD Trial to examine the impact of prior treatment on the effects of randomised study drugs on mortality and exacerbations. We used data on 16 417 patients with moderate COPD and heightened cardiovascular risk and information on prior medications to examine the effects of fluticasone furoate (FF), vilanterol (VI) and combined FF/VI compared to placebo on moderate and severe exacerbation as well as mortality. The study was event-driven with a median study exposure of 1.8 years. This study was registered with ClinicalTrials.gov, number NCT01313676. There were no consistent associations between treatment prior to study entry and the effects of FF, VI or FF/VI on exacerbations during the study. However, patients taking inhaled corticosteroids and one or more bronchodilators prior to study entry seemed to have a better effect of active treatments than of placebo on mortality (hazard ratio for FF/VI 0.65, 95% CI 0.48–0.89). Survival in those randomised to placebo was independent of treatment prior to study enrolment. Prior treatment appears to affect treatment effects on mortality but not exacerbations in a randomised controlled trial of patients with COPD and heightened cardiovascular risk.http://openres.ersjournals.com/content/5/1/00203-2018.full |
| spellingShingle | Jørgen Vestbo Mark Dransfield Julie A. Anderson Robert D. Brook Peter M.A. Calverley Bartolome R. Celli Nicholas J. Cowans Courtney Crim Fernando Martinez David E. Newby Julie Yates Peter Lange Impact of pre-enrolment medication use on clinical outcomes in SUMMIT ERJ Open Research |
| title | Impact of pre-enrolment medication use on clinical outcomes in SUMMIT |
| title_full | Impact of pre-enrolment medication use on clinical outcomes in SUMMIT |
| title_fullStr | Impact of pre-enrolment medication use on clinical outcomes in SUMMIT |
| title_full_unstemmed | Impact of pre-enrolment medication use on clinical outcomes in SUMMIT |
| title_short | Impact of pre-enrolment medication use on clinical outcomes in SUMMIT |
| title_sort | impact of pre enrolment medication use on clinical outcomes in summit |
| url | http://openres.ersjournals.com/content/5/1/00203-2018.full |
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