Association of Incident Pneumonia and Exacerbations with Extrafine Triple Therapy in One Single Inhaler in COPD

Efficacy and safety of extrafine fixed triple combination of beclometasone dipropionate, formoterol fumarate,and glycopyrronium bromide (BDP/FF/GB; 100/6/12·5 µg, two actuations BID via pMDI; 'fixed triple') has been recently demonstrated in two phase III trials. Fixed triple has shown superiority in improving lung function and reducing moderate/severe exacerbations versus BDP/FF (Foster® 100/6 µg, two actuations BID via pMDI; TRILOGY – 52 weeks,1368 patients. Singh et al. Lancet 2016; 388: 96373) and versus tiotropium (18 µg one inhalation OD via DPI; TRINITY- 52 weeks, 2691 patients. Vestbo et al. ERJ 2016; 48: Suppl. 60. OA1972).Increase in pneumonia risk associated with ICS containing medications is a known class effect. The risk/benefit balance of extrafine fixed triple was evaluated by comparing variations in pneumonia and exacerbation events. Information on moderate/severe exacerbations and confirmed pneumonia was extracted from TRINITY and TRILOGY. A frequency plot was generated considering days in the study versus cumulative number of events. The analysis showed that, in two independent populations of COPD patients treated with an ICS containing extrafine fixed triple combination, the number of incident pneumonia remains very small compared to that of moderate/severe exacerbations. The benefit observed in reducing the absolute number of exacerbations outweighs the increase observed in absolute number of pneumonia, thus confirming the positive risk-benefit balance of extrafine fixed triple in severe/very severe COPD patients.