Risk of pneumonia in chronic obstructive pulmonary disease patients treated with inhaled corticosteroids. Results from the OUTPUL study

Background ICS treatment has been shown to be associated with a reduction of exacerbations, but may also increase the risk of pneumonia. Objectives To assess whether use of ICS, with or without LABA, increases the risk of pneumonia in COPD patients. Methods A population based cohort study was performed using linked discharge and drug prescription databases in Lazio (Central Italy). Patients aged 45+, discharged with COPD diagnosis in 2006-2009 were enrolled and followed until first admission for pneumonia, death, or study end (31 December 2012). Cases of pneumonia were identified through a validated alghoritm*. A nested case control approach was used to estimate the rate ratio (RR) associated with ICS current (low, medium, high dose) or past use adjusted for age, gender, number of exacerbations in the previous year and comorbidities. Results The cohort included 19288 patients, 3141 had an event of pneumonia (incidence rate: for current use 87/1000py, for past use 32/1000py). The adjusted RR of hospitalization for pneumonia associated with current respect to no use was 2.29 (95%CI: 1.99-2.63); for past use RR 1.23 (95%CI: 1.07-1.42. A significant increasing trend in the risk was detected starting from the medium doses. For older patients (80+), the rate was higher than for younger patients, both for current and for past use. Conclusions ICS use is associated with an excess risk of pneumonia requiring hospitalization. The effect was greatest for those prescribed higher doses and in very elderly. *Cascini Set al. Pneumonia burden in elderly patients: a classification algorithm using administrative data. BMC Infect Dis 2013, 25;13:559.