Inhaled corticosteroids and mortality in chronic obstructive pulmonary disease
- D D Sin1,2,
- L Wu2,
- J A Anderson3,
- N R Anthonisen4,
- A S Buist5,
- P S Burge6,
- P M Calverley7,
- J E Connett8,
- B Lindmark9,
- R A Pauwels10,†,
- D S Postma11,
- J B Soriano12,
- W Szafranski13,
- J Vestbo14
- 1The James Hogg iCAPTURE Center for Cardiovascular and Pulmonary Research, St Paul’s Hospital, Vancouver, British Columbia, Canada
- 2Department of Medicine, University of British Columbia, Vancouver, British Columbia, Canada
- 3Department of Medical Statistics, GlaxoSmithKline R&D, UK
- 4Department of Medicine, University of Manitoba, Winnipeg, Manitoba, Canada
- 5Department of Medicine, Oregon Health and Science University, Portland, Oregon, USA
- 6Heartlands Hospital NHS Trust, Birmingham, UK
- 7University Hospital Aintree, Liverpool, UK
- 8Division of Biostatistics, School of Public Health, University of Minnesota, Minneapolis, Minnesota, USA
- 9AstraZeneca R&D, Lund, Sweden
- 10Department of Respiratory Diseases, Ghent University Hospital, Ghent, Belgium
- 11Department of Pulmonology, University of Groningen, the Netherlands
- 12Fundación Caubcc-Cimera, Palma de Mallorca, Balearic Islands, Spain
- 13Department of Lung Diseases, Voivodeship Specialist Hospital, Radom, Poland
- 14South Manchester University Hospital NHS Trust, Wythenshawe Hospital, Manchester, UK
- Correspondence to:
Dr D D Sin
James Hogg iCAPTURE Center for Cardiovascular and Pulmonary Research, St Paul’s Hospital, 1081 Burrard Street, Vancouver, BC, Canada, V6Z 1Y6; dsinmrl.ubc.ca
- Received 15 April 2005
- Accepted 22 September 2005
- Published Online First 14 October 2005
Abstract
Background: Clinical studies suggest that inhaled corticosteroids reduce exacerbations and improve health status in chronic obstructive pulmonary disease (COPD). However, their effect on mortality is unknown.
Methods: A pooled analysis, based on intention to treat, of individual patient data from seven randomised trials (involving 5085 patients) was performed in which the effects of inhaled corticosteroids and placebo were compared over at least 12 months in patients with stable COPD. The end point was all-cause mortality.
Results: Overall, 4% of the participants died during a mean follow up period of 26 months. Inhaled corticosteroids reduced all-cause mortality by about 25% relative to placebo. Stratification by individual trials and adjustments for age, sex, baseline post-bronchodilator percentage predicted forced expiratory volume in 1 second, smoking status, and body mass index did not materially change the results (adjusted hazard ratio (HR) 0.73; 95% confidence interval (CI) 0.55 to 0.96). Although there was considerable overlap between subgroups in terms of effect sizes, the beneficial effect was especially noticeable in women (adjusted HR 0.46; 95% CI 0.24 to 0.91) and former smokers (adjusted HR 0.60; 95% CI 0.39 to 0.93).
Conclusions: Inhaled corticosteroids reduce all-cause mortality in COPD. Further studies are required to determine whether the survival benefits persist beyond 2–3 years.
Footnotes
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↵† Deceased.
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Published Online First 14 October 2005
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This work was funded in part by the Michael Smith/St Paul’s Hospital Foundation for Health Research and by a Canada Research Chair.
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Competing interests: DDS has received honoraria for speaking engagements from AstraZeneca (AZ) and GlaxoSmithKline (GSK) and has received consultancy fees and research funding from GSK. JV has received honoraria for speaking engagements and research funding from AZ and GSK. JAA is currently an employee of GSK R&D, manufacturer of respiratory drugs. JBS was an employee of GSK. PMAC has received honoraria for speaking engagements and research funding from AZ and GSK. RP received honoraria for speaking engagements and research funding from AZ and GSK. NRA and ASB are members of a respiratory advisory board for GSK. BL is currently an employee of AZ, manufacturer of respiratory drugs. DSP has received honoraria for speaking engagements and research funding from AZ and GSK.
