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A Pooled Analysis of FEV 1 Decline in COPD Patients Randomized to Inhaled Corticosteroids or Placebo

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Title: A Pooled Analysis of FEV 1 Decline in COPD Patients Randomized to Inhaled Corticosteroids or Placebo
Authors: Soriano, JB, Sin, DD, Zhang, X, Camp, PG, Anderson, JA, Anthonisen, NR, Buist, AS, Burge, PS, Calverley, PM, Connett, JE, Petersson, S, Postma, DS, Szafranski, W, Vestbo, Jørgen
Source: Soriano, J B, Sin, D D, Zhang, X, Camp, P G, Anderson, J A, Anthonisen, N R, Buist, A S, Burge, P S, Calverley, P M, Connett, J E, Petersson, S, Postma, D S, Szafranski, W & Vestbo, J 2007, 'A pooled analysis of FEV1 decline in COPD patients randomized to inhaled corticosteroids or placebo', Chest, vol. 131, no. 3, pp. 682-689. https://doi.org/10.1378/chest.06-1696
Publisher Information: Elsevier BV, 2007.
Publication Year: 2007
Subject Terms: Male, AIRWAY, Natural history, CONTROLLED-TRIAL, OBSTRUCTIVE PULMONARY-DISEASE, Pooled analysis, corticosteroids, DOUBLE-BLIND, FEV1, Pulmonary Disease, Chronic Obstructive, 03 medical and health sciences, Sex Factors, 0302 clinical medicine, Adrenal Cortex Hormones, Cause of Death, Forced Expiratory Volume, Administration, Inhalation, EPIDEMIOLOGY, COPD, Corticosteroids, Humans, Multicenter Studies as Topic, METAANALYSIS, Aged, Randomized Controlled Trials as Topic, FLUTICASONE PROPIONATE, Smoking, Middle Aged, Long-Term Care, 3. Good health, LUNG-FUNCTION, Survival Rate, natural history, ASTHMA, Female, Smoking Cessation, pooled analysis, SMOKING, Follow-Up Studies
Description: There is controversy about whether therapy with inhaled corticosteroids (ICSs) modifies the natural history of COPD, characterized by an accelerated decline in FEV(1).The Inhaled Steroids Effect Evaluation in COPD (ISEEC) study is a pooled study of patient-level data from seven long-term randomized controlled trials of ICS vs placebo lasting >/= 12 months in patients with moderate-to-severe COPD. We have previously reported a survival benefit for ICS therapy in COPD patients using ISEEC data. We aimed to determine whether the regular use of ICSs vs placebo improves FEV(1) decline in COPD patients, and whether this relationship is modified by gender and smoking.There were 3,911 randomized participants (29.2% female) in this analysis. In the first 6 months after randomization, ICS use was associated with a significant mean (+/- SE) relative increase in FEV(1) of 2.42 +/- 0.19% compared with placebo (p < 0.01), which is quantifiable in absolute terms as 42 mL in men and 29 mL in women over 6 months. From 6 to 36 months, there was no significant difference between placebo and ICS therapy in terms of FEV(1) decline (-0.01 +/- 0.09%; p = 0.86). The initial treatment effect was dependent on smoking status and gender. Smokers who continued to smoke had a smaller increase in FEV(1) during the first 6 months than did ex-smokers. Female ex-smokers had a larger increase in FEV(1) with ICS therapy than did male ex-smokers.We conclude that in COPD in the first 6 months of treatment, ICS therapy is more effective in ex-smokers than in current smokers with COPD in improving lung function, and women may have a bigger response to ICSs than men. However, it seems that after 6 months, ICS therapy does not modify the decline in FEV(1) among those who completed these randomized clinical trials.
Document Type: Article
Language: English
ISSN: 0012-3692
DOI: 10.1378/chest.06-1696
Access URL: https://pubmed.ncbi.nlm.nih.gov/17356080
https://research.manchester.ac.uk/en/publications/10eb644c-c8ca-4f35-b85d-c64df52a6dbc
https://doi.org/10.1378/chest.06-1696
http://journal.publications.chestnet.org/article.aspx?articleid=1084997
https://pubmed.ncbi.nlm.nih.gov/17356080/
https://www.sciencedirect.com/science/article/pii/S0012369215388814
https://www.research.manchester.ac.uk/portal/en/publications/a-pooled-analysis-of-fev1-decline-in-copd-patients-randomized-to-inhaled-corticosteroids-or-placebo(10eb644c-c8ca-4f35-b85d-c64df52a6dbc).html
https://experts.umn.edu/en/publications/a-pooled-analysis-of-fevsub1sub-decline-in-copd-patients-randomiz
https://core.ac.uk/display/92456337
Rights: Elsevier TDM
Accession Number: edsair.doi.dedup.....6795c442171127ffe9fd1be41f15d865
Database: OpenAIRE
Description
Abstract:There is controversy about whether therapy with inhaled corticosteroids (ICSs) modifies the natural history of COPD, characterized by an accelerated decline in FEV(1).The Inhaled Steroids Effect Evaluation in COPD (ISEEC) study is a pooled study of patient-level data from seven long-term randomized controlled trials of ICS vs placebo lasting >/= 12 months in patients with moderate-to-severe COPD. We have previously reported a survival benefit for ICS therapy in COPD patients using ISEEC data. We aimed to determine whether the regular use of ICSs vs placebo improves FEV(1) decline in COPD patients, and whether this relationship is modified by gender and smoking.There were 3,911 randomized participants (29.2% female) in this analysis. In the first 6 months after randomization, ICS use was associated with a significant mean (+/- SE) relative increase in FEV(1) of 2.42 +/- 0.19% compared with placebo (p < 0.01), which is quantifiable in absolute terms as 42 mL in men and 29 mL in women over 6 months. From 6 to 36 months, there was no significant difference between placebo and ICS therapy in terms of FEV(1) decline (-0.01 +/- 0.09%; p = 0.86). The initial treatment effect was dependent on smoking status and gender. Smokers who continued to smoke had a smaller increase in FEV(1) during the first 6 months than did ex-smokers. Female ex-smokers had a larger increase in FEV(1) with ICS therapy than did male ex-smokers.We conclude that in COPD in the first 6 months of treatment, ICS therapy is more effective in ex-smokers than in current smokers with COPD in improving lung function, and women may have a bigger response to ICSs than men. However, it seems that after 6 months, ICS therapy does not modify the decline in FEV(1) among those who completed these randomized clinical trials.
ISSN:00123692
DOI:10.1378/chest.06-1696