title: Pneumonia risk in COPD patients receiving inhaled corticosteroids alone or in combination: TORCH study results.
abstract: Inhaled corticosteroids (ICS) are important in reducing exacerbation frequency associated with chronic obstructive pulmonary disease (COPD). However, little is known about the risk of associated infections. In a post hoc analysis of the TOwards a Revolution in COPD Health (TORCH) study, we analysed and identified potential risk factors for adverse event reports of pneumonia in this randomised, double-blind trial comparing twice-daily inhaled salmeterol (SAL) 50 microg, fluticasone propionate (FP) 500 microg, and the combination (SFC) with placebo in 6,184 patients with moderate-to-severe COPD over 3 yrs. Despite a higher withdrawal rate in the placebo arm, after adjusting for time on treatment, a greater rate of pneumonia was reported in the FP and SFC treatment arms (84 and 88 per 1,000 treatment-yrs, respectively) compared with SAL and placebo (52 and 52 per 1,000 treatment-yrs, respectively). Risk factors for pneumonia were age > or =55 yrs, forced expiratory volume in 1 s <50% predicted, COPD exacerbations in the year prior to the study, worse Medical Research Council dyspnoea scores and body mass index <25 kg.m(-2). No increase in pneumonia deaths with SFC was observed; this could not be concluded for FP. Despite the benefits of ICS-containing regimens in COPD management, healthcare providers should remain vigilant regarding the possible development of pneumonia as a complication in COPD patients receiving such therapies.
authors.affiliation: GlaxoSmithKline, Research Triangle Park, NC 27709-3398, USA. courtney.c.crim@gsk.com
authors.forename: C
authors.initials: C
authors.lastname: Crim
authors.forename: P M A
authors.initials: PM
authors.lastname: Calverley
authors.forename: J A
authors.initials: JA
authors.lastname: Anderson
authors.forename: B
authors.initials: B
authors.lastname: Celli
authors.forename: G T
authors.initials: GT
authors.lastname: Ferguson
authors.forename: C
authors.initials: C
authors.lastname: Jenkins
authors.forename: P W
authors.initials: PW
authors.lastname: Jones
authors.forename: L R
authors.initials: LR
authors.lastname: Willits
authors.forename: J C
authors.initials: JC
authors.lastname: Yates
authors.forename: J
authors.initials: J
authors.lastname: Vestbo
mesh_terms: D000280:Administration, Inhalation; D000368:Aged; D000420:Albuterol / Q000008:administration & dosage / Q000031:analogs & derivatives*; D000730:Androstadienes / Q000008:administration & dosage*; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage*; D001993:Bronchodilator Agents / Q000008:administration & dosage*; D015331:Cohort Studies; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D005260:Female; D000068298:Fluticasone; D006801:Humans; D008297:Male; D008875:Middle Aged; D011014:Pneumonia / Q000175:diagnosis / Q000453:epidemiology*; D029424:Pulmonary Disease, Chronic Obstructive / Q000150:complications / Q000188:drug therapy*; D012307:Risk Factors; D000068299:Salmeterol Xinafoate
chemical_list: D000730:Androstadienes; D000893:Anti-Inflammatory Agents; D001993:Bronchodilator Agents; D000068299:Salmeterol Xinafoate; D000068298:Fluticasone; D000420:Albuterol