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Pneumonia risk in COPD patients receiving inhaled corticosteroids alone or in combination: TORCH study results

¹ GlaxoSmithKline, Research Triangle Park, NC, ⁴ Caritas-St Elizabeth’s Medical Center, Boston, MA, and ⁵ Pulmonary Research Institute of Southeast Michigan, Livonia, MI, USA. ² University Hospital Aintree, Liverpool, ³ GlaxoSmithKline, Middlesex ⁷ University of London, London, and ⁹ Wythenshawe Hospital, Manchester, UK. ⁶ Woolcock Institute of Medical Research, Camperdown, Australia. ⁸ Hvidovre Hospital, Hvidovre, Denmark.

CORRESPONDENCE: C. Crim, Medicine Development Centre – Global Clinical Development, GlaxoSmithKline, Five Moore Drive, P.O. Box 13398, Research Triangle Park, NC 27709-3398, USA. E-mail: courtney.c.crim{at}gsk.com

Keywords: Chronic obstructive pulmonary disease, fluticasone propionate, inhaled corticosteroid, pneumonia, safety

Received: December 22, 2008
Accepted April 26, 2009

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 µg, fluticasone propionate (FP) 500 µg, 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 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.