TY - JOUR

T1 - Impact of pre-enrolment medication use on clinical outcomes in SUMMIT

AU - Vestbo, Jørgen

AU - Dransfield, Mark

AU - Anderson, Julie A.

AU - Brook, Robert D.

AU - Calverley, Peter M. A.

AU - Celli, Bartolome R.

AU - Cowans, Nicholas J.

AU - Crim, Courtney

AU - Martinez, Fernando

AU - Newby, David E.

AU - Yates, Julie

AU - Lange, Peter

AU - SUMMIT Investigators

PY - 2019/2/1

Y1 - 2019/2/1

N2 - 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 16417 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.

AB - 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 16417 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.

KW - FLUTICASONE PROPIONATE

KW - THERAPEUTIC TRIALS

KW - DOUBLE-BLIND

KW - COPD

KW - WITHDRAWAL

KW - EXACERBATIONS

KW - TIOTROPIUM

KW - VILANTEROL

KW - SURVIVAL

KW - FUROATE

U2 - 10.1183/23120541.00203-2018

DO - 10.1183/23120541.00203-2018

M3 - Journal article

C2 - 30815468

VL - 5

JO - ERJ Open Research

JF - ERJ Open Research

SN - 2312-0541

IS - 1

M1 - 203

ER -