Article open access publication

Impact of pre-enrolment medication use on clinical outcomes in SUMMIT

ERJ Open Research, European Respiratory Society (ERS), ISSN 2312-0541

Volume 5, 1, 2019

DOI:10.1183/23120541.00203-2018, Dimensions: pub.1112403259, PMC: PMC6387990, PMID: 30815468,



  1. (1) Manchester University NHS Foundation Trust, grid.498924.a
  2. (2) University of Manchester, grid.5379.8
  3. (3) University of Alabama at Birmingham, grid.265892.2
  4. (4) GlaxoSmithKline (United Kingdom), grid.418236.a
  5. (5) Michigan Medicine, grid.412590.b
  6. (6) University of Liverpool, Dept of Medicine, Clinical Sciences Centre, University Hospital Aintree, Liverpool, UK
  7. (7) Pulmonary and Critical Care Division, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA
  8. (8) Veramed Ltd, Twickenham, UK
  9. (9) Research and Development, GlaxoSmithKline, Research Triangle Park, NC, USA
  10. (10) Cornell University, grid.5386.8
  11. (11) University of Edinburgh, grid.4305.2
  12. (12) Medical Unit, Respiratory Section, Herlev Hospital, Copenhagen University Hospital, Copenhagen, Denmark
  13. (13) University of Copenhagen, grid.5254.6, KU


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, 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.


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