作者: Salman H. Siddiqui , Alessandro Guasconi , Jørgen Vestbo , Paul Jones , Alvar Agusti
DOI: 10.1164/RCCM.201502-0235LE
关键词: Medicine 、 COPD 、 Randomized controlled trial 、 Proportional hazards model 、 Quartile 、 Post-hoc analysis 、 Formoterol 、 Internal medicine 、 Immunology 、 Exacerbation 、 Inhaler
摘要: To the Editor: Chronic obstructive pulmonary disease (COPD) is a heterogeneous condition (1). The identification of COPD phenotypes may allow stratified treatment approaches that modulate discrete mechanisms. Peripheral blood eosinophilia both common and repeatable finding in (2). In addition, presence blood/sputum associated with significant proportion exacerbations (3, 4) favorable response to systemic steroids (5). However, role eosinophils stratifying inhaled corticosteroid/long-acting β-agonist combinations poorly understood. The FORWARD (Foster 48-Week Trial Reduce Exacerbations COPD) study was randomized, double-blind, parallel group trial compared 48 weeks extrafine beclomethasone dipropionate plus formoterol fumarate (BDP/FF), 100/6 μg pressurized metered-dose inhaler, two inhalations twice day, versus FF 12 one inhalation patients severe history (clinical registered www.clinicaltrials.gov [NCT 00929851]). results have been reported (6) showed reduction exacerbation rate (28%) improvement lung function BDP/FF treatment. Here we evaluate hypothesis these differences differ according baseline eosinophil count by performing post hoc analysis on data. Methods The median (quartile 1; quartile 3) 181.6 (110.4; 279.8), distribution counts shown Figure E1 online supplement. (n = 1,184) were into groups basis count. clinical characteristics population across quartiles are Table E1. following endpoints analyzed: over course weeks, using negative binomial model for adjusted rates, Kaplan-Meier analysis, Cox proportional hazard time first event; change from predose morning FEV1 at linear mixed repeated measurements; St. George’s Respiratory Questionnaire total score an covariance model. Further details models provided Additional analyses percentage thresholds considering absolute as continuous variable also performed. A predictive (see supplement details) future estimated, accounting variety factors influence (7). effect adverse events, particular pneumonia, evaluated.