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 mg, fluticasone propionate (FP) 500 mg, and the combination (SFC) with placebo in 6,184 patients with moderateto-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 treatmentyrs, respectively). Risk factors for pneumonia were age o55 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.

Inhaled Corticosteroids in Lung Diseases

“…Growth suppression is dose and device dependent and has been reported with low to medium doses of BDP MDI (34) and BUD dry-powder inhaler (DPI) (70,71) in children 4 to 17 years of age and in infants 2 years of age or younger with FP MDI plus VHC (14) but not with low-to medium-dose FP DPI, mometasone furoate DPI, or ciclesonide MDI (71). Several large studies have shown that ICS alone or in combination is associated with increased pneumonia risk and even death from pneumonia, with a dose-related risk (28,55,72,73).…”

Erratum to: Safety Considerations of Inhaled Corticosteroids in the Elderly

“…The risk was evident, especially in the elderly and in those with more severe disease and lower lung function. However, in this metaanalysis data on elderly seems limited, because information only derives from a post-hoc analysis of the TORCH (TOwards a Revolution in COPD Health) trial [60]. In this trial, the hazard ratio for pneumonia increased from 1.62 for patients aged 55-64 years to 2.18 for patients aged C75 years, in comparison with those \55 years.…”

Tratamento farmacológico da DPOC

“…In various clinical trials, the use of ICs in isolation or in combination with LABAs increased the adverse effects, principally the risk of developing pneumonia, when compared with the use of a placebo. (43,64,79) However, a study evaluating those same drug combinations showed that the medications had no impact on the risk of developing pneumonia. (47) The use of ICs has not been shown to increase the risk of …”

“…(32) In contrast, an observational study compared those same medications and found no differences regarding cardiac ischemic events, arrhythmias, or pneumonia. (68) The use of fluticasone was compared with that of salmeterol in isolation, (19,20,43,79) as well as with that of LAMAs in isolation, (69) and was shown to increase the risk of developing pneumonia.…”