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

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

Research output: Contribution to journalArticlepeer-review


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.

Original languageEnglish
JournalERJ Open Research
Issue number1
Early online date25 Feb 2019
Publication statusE-pub ahead of print - 25 Feb 2019


Dive into the research topics of 'Impact of pre-enrolment medication use on clinical outcomes in SUMMIT'. Together they form a unique fingerprint.

Cite this