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Pooled subpopulation analyses of the effects of roflumilast on exacerbations and lung function in COPD.
Respir Med. 2014 Feb; 108(2):366-75.RM

Abstract

BACKGROUND

This post-hoc analysis examined the impact of roflumilast on chronic obstructive pulmonary disease (COPD) exacerbations and lung function in patients with COPD who received concomitant long-acting β2-agonists (LABA) with or without prior inhaled corticosteroid (ICS) and the influence of various demographic and clinical characteristics on these outcomes.

METHODS

Data were pooled from 2 double-blind, placebo-controlled, 52-week studies of once-daily roflumilast 500 μg in patients with COPD. Endpoints were mean rate of exacerbations and change from baseline in pre- and postbronchodilator FEV1.

RESULTS

In this pooled analysis (N = 3091), addition of roflumilast to LABAs for 1 year in patients who discontinued ICS prior to study entry (n = 945) significantly reduced the risk of COPD exacerbations vs. placebo by 19.2% (p < 0.05) and significantly improved pre- and postbronchodilator FEV1 by 40 mL and 34 mL, respectively (both, p < 0.01). Similar improvements were observed in patients who received concomitant LABAs but were not taking ICS prior to study entry (n = 597). A significant reduction in COPD exacerbation risk with roflumilast vs. placebo was observed regardless of age or smoking status, and in patients who had severe or very severe COPD. Significantly improved lung function was observed with roflumilast in all the subgroups (p < 0.05), with the exception of patients with moderate COPD.

CONCLUSIONS

Roflumilast reduced exacerbation rates and improved lung function in patients with COPD who received concomitant LABA, regardless of prior ICS use, and across various patient subgroups regardless of age and smoking status.

CLINICALTRIALSGOV REGISTRATION NUMBERS

NCT00297102 (M2-124) and NCT00297115 (M2-125).

Authors+Show Affiliations

Baylor College of Medicine, Houston, TX 77030, USA. Electronic address: hanania@bcm.edu.University of Liverpool, Liverpool L69 3BX, England, UK.University of Alabama at Birmingham, Birmingham, AL 35233, USA.North Shore Medical Arts, Great Neck, NY 11021, USA.Takeda Pharmaceuticals International GmbH, Zürich, Switzerland.Forest Research Institute, Jersey City, NJ 07311, USA.Takeda Pharmaceuticals International GmbH, Zürich, Switzerland.Forest Research Institute, Jersey City, NJ 07311, USA.

Pub Type(s)

Journal Article
Meta-Analysis
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

24120253

Citation

Hanania, Nicola A., et al. "Pooled Subpopulation Analyses of the Effects of Roflumilast On Exacerbations and Lung Function in COPD." Respiratory Medicine, vol. 108, no. 2, 2014, pp. 366-75.
Hanania NA, Calverley PM, Dransfield MT, et al. Pooled subpopulation analyses of the effects of roflumilast on exacerbations and lung function in COPD. Respir Med. 2014;108(2):366-75.
Hanania, N. A., Calverley, P. M., Dransfield, M. T., Karpel, J. P., Brose, M., Zhu, H., Goehring, U. M., & Rowe, P. (2014). Pooled subpopulation analyses of the effects of roflumilast on exacerbations and lung function in COPD. Respiratory Medicine, 108(2), 366-75. https://doi.org/10.1016/j.rmed.2013.09.018
Hanania NA, et al. Pooled Subpopulation Analyses of the Effects of Roflumilast On Exacerbations and Lung Function in COPD. Respir Med. 2014;108(2):366-75. PubMed PMID: 24120253.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Pooled subpopulation analyses of the effects of roflumilast on exacerbations and lung function in COPD. AU - Hanania,Nicola A, AU - Calverley,Peter M A, AU - Dransfield,Mark T, AU - Karpel,Jill P, AU - Brose,Manja, AU - Zhu,Haiyuan, AU - Goehring,Udo-Michael, AU - Rowe,Paul, Y1 - 2013/09/30/ PY - 2013/07/03/received PY - 2013/09/17/revised PY - 2013/09/21/accepted PY - 2013/10/15/entrez PY - 2013/10/15/pubmed PY - 2014/9/30/medline KW - Chronic obstructive pulmonary disease KW - Exacerbation KW - Inhaled corticosteroids KW - Long-acting β(2)-agonists KW - Lung function KW - Roflumilast SP - 366 EP - 75 JF - Respiratory medicine JO - Respir Med VL - 108 IS - 2 N2 - BACKGROUND: This post-hoc analysis examined the impact of roflumilast on chronic obstructive pulmonary disease (COPD) exacerbations and lung function in patients with COPD who received concomitant long-acting β2-agonists (LABA) with or without prior inhaled corticosteroid (ICS) and the influence of various demographic and clinical characteristics on these outcomes. METHODS: Data were pooled from 2 double-blind, placebo-controlled, 52-week studies of once-daily roflumilast 500 μg in patients with COPD. Endpoints were mean rate of exacerbations and change from baseline in pre- and postbronchodilator FEV1. RESULTS: In this pooled analysis (N = 3091), addition of roflumilast to LABAs for 1 year in patients who discontinued ICS prior to study entry (n = 945) significantly reduced the risk of COPD exacerbations vs. placebo by 19.2% (p < 0.05) and significantly improved pre- and postbronchodilator FEV1 by 40 mL and 34 mL, respectively (both, p < 0.01). Similar improvements were observed in patients who received concomitant LABAs but were not taking ICS prior to study entry (n = 597). A significant reduction in COPD exacerbation risk with roflumilast vs. placebo was observed regardless of age or smoking status, and in patients who had severe or very severe COPD. Significantly improved lung function was observed with roflumilast in all the subgroups (p < 0.05), with the exception of patients with moderate COPD. CONCLUSIONS: Roflumilast reduced exacerbation rates and improved lung function in patients with COPD who received concomitant LABA, regardless of prior ICS use, and across various patient subgroups regardless of age and smoking status. CLINICALTRIALSGOV REGISTRATION NUMBERS: NCT00297102 (M2-124) and NCT00297115 (M2-125). SN - 1532-3064 UR - https://www.unboundmedicine.com/medline/citation/24120253/Pooled_subpopulation_analyses_of_the_effects_of_roflumilast_on_exacerbations_and_lung_function_in_COPD_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0954-6111(13)00383-1 DB - PRIME DP - Unbound Medicine ER -