Exacerbator subtypes in the tiotropium safety and performance in respimat (TIOSPIR™) trial

Background: The long-acting antimuscarinic antagonist (LAMA) tiotropium is used to prevent exacerbations of chronic obstructive pulmonary disease (COPD) but information is limited on how often these events occur during LAMA therapy and which factors predict exacerbations. Methods: A post-hoc exploratory pooled analysis of COPD patients with and without COPD exacerbations in TIOSPIR was performed. Baseline characteristics discriminating between patients without exacerbation (yearly exacerbation rate [YER]=0), and infrequent (YER≤1) and frequent (YER>1) exacerbators during the trial were identified using descriptive statistics. Results: Of 17,116 patients, 8774 reported no exacerbation,4896 one and 3446 more than one exacerbation. Some baseline characteristics were similar between groups (age, body mass index) but patients reporting exacerbations were more likely to be female, have a history of frequent exacerbations, have lower mean forced expiratory volume in 1 s (FEV 1 ) (GOLD III/IV) and to use more long-acting β 2 -agonists (LABA) and inhaled corticosteroids (ICS) at baseline (table). YER 0 n=8774 YER ≤1 n=4896 YER >1 n=3446 % female 25.1 30.1 34.8 Mean FEV1 % pred 50.1 47.9 44.3 % GOLD III/IV 45.4 52.0 62.7 % LABA use 55.4 63.8 75.3 % ICS use 52.0 62.0 72.6 % >1 Exac past yr 14.8 20.9 31.8 Conclusions: The large TIOSPIR dataset supports the relationship between established predictive variables, like lung function and exacerbation history, and exacerbation risk, also during LAMA therapy. Age, BMI and male gender had no prognostic adverse influence on exacerbations. Funded by Boehringer Ingelheim.