Inhaled corticosteroid use in patients with chronic obstructive pulmonary disease and the risk of pneumonia: a retrospective claims data analysis

Abstract

BackgroundThe use of inhaled corticosteroids in patients with chronic obstructive pulmonary disease (COPD) has been associated with an increased risk of pneumonia in controlled clinical trials and case-control analyses.ObjectiveUsing claims databases as a research model of real-world diagnosis and treatment, to determine if the use and dose of inhaled corticosteroids (ICS) among patients with newly diagnosed COPD are associated with increased risk of pneumonia.Patients and methodsThis was a retrospective cohort analysis of patients diagnosed with COPD between January 01, 2006 and September 30, 2010, drawn from databases (years 2006–2010). Patients (aged ≥45 years) were followed until first pneumonia diagnosis, end of benefit enrollment, or December 31, 2010, whichever was earliest. A Cox proportional hazard model was used to assess the association of ICS use and risk of pneumonia, controlling for baseline characteristics. Daily ICS use was classified into low, medium, and high doses (1 μg–499 μg, 500 μg–999 μg, and ≥1000 μg fluticasone equivalents daily) and was modeled as a time-dependent variable.ResultsAmong 135,445 qualifying patients with a total of 243,097 person-years, there were 1020 pneumonia incidences out of 5677 person-years on ICS (crude incidence rate, 0.180 per person-year), and 27,730 pneumonia incidences out of 237,420 person-years not on ICS (crude incidence rate, 0.117 per person-year). ICS use was associated with a dose-related increase in risk of pneumonia, with adjusted hazard ratios (versus no use; (95% confidence interval) of 1.38 (1.27–1.49) for low-dose users, 1.69 (1.52–1.88) for medium-dose users, and 2.57 (1.98–3.33) for high-dose users (P < 0.01 versus no use and between doses).ConclusionThe use of ICS in newly diagnosed patients with COPD is potentially associated with a dose-related increase in the risk of pneumonia.

Inhaled corticosteroids and the increased risk of pneumonia: what’s new? A 2015 updated review

“…Several other recent case-control studies confirm previous reports of an increased, dose-related pneumonia risk with ICS use in patients with COPD [Thornton Snider et al 2012;Yawn et al 2013;DiSantostefano et al 2014]. One study also reported a 90% relative increase in the risk of recurrent pneumonia among high-risk individuals who survived a first episode of pneumonia [Eurich et al 2013].…”

Erratum to: Safety Considerations of Inhaled Corticosteroids in the Elderly

“…Arguably, the most serious side effect is the increased incidence of pneumonia, which has been observed among patients with COPD both in controlled clinical trials and case-control analyses. In a recent retrospective cohort analysis on patients diagnosed with COPD [22], the use of ICS was associated with an increase in the risk of pneumonia. With regard to the risk of bone fractures associated with long-term use of ICS in the elderly population, the relative increase in fracture risk should be mostly weighted against the relative reduction of exacerbations in subjects with COPD.…”

Perspectives of pharmacological therapy of chronic obstructive pulmonary disease: opportunities of dual bronchodilation and a role of inhaled steroids. Expert Council Consensus

“…В по ледние годы в число нежелательных явлений тера пии иГКС у пациентов ХОБЛ также включено повы шение риска развития пневмонии. В крупном когортном исследовании [30] (n = 135 445) у больных ХОБЛ продемонстрировано статистически досто верное дозозависимое повышение риска пневмонии при использовании иГКС у больных с впервые диаг ностированной ХОБЛ: примерно на 28 % при низ ких дозах, на 111 % -при средних и на 224 % -при высоких дозах иГКС. Развитие пневмонии также сопровождается увеличением стоимости медицин ского обслуживания пациентов с ХОБЛ.…”