P295 Efficacy and safety of tiotropium/olodaterol in patients with copd by ats category. (15th November 2016)

• Record Type: Journal Article
• Authors: Maltais, F; Pizzichini, E; Grönke, L; Voß, F; Derom, E
• Is Part Of: Thorax. Volume 71(2016)Supplement 3
• Page Start: A252
• Page End: A253
• Publication Date: 2016-11-15
• Subjects: Chest -- Diseases -- Periodicals; Thorax; Chest -- Diseases; Periodicals; Periodicals; 617.54
• DOI: 10.1136/thoraxjnl-2016-209333.438
• Languages: English
• ISSNs: 0040-6376

Abstract

Abstract : Rationale: The once-daily combination of tiotropium (T), a long-acting muscarinic antagonist, and olodaterol (O), a long-acting β2 -agonist, has demonstrated efficacy and safety in chronic obstructive pulmonary disease (COPD). 1 Recently, it has been demonstrated that patients with milder disease (GOLD 2) have better bronchodilator responses compared to those with more severe disease. This post hoc analysis investigated whether the response to T/O and to T alone is influenced by forced expiratory volume in 1 second (FEV1 ) American Thoracic Society (ATS) category (mild, moderate or severe). Methods: In total, 5162 patients were randomised to O 5 µg, T 2.5 µg, T 5 µg, T/O 2.5/5 µg or T/O 5/5 µg (via Respimat ® inhaler) in two 52-week, parallel-group, double-blind studies (TONADO ® 1 and 2: NCT01431274 ; NCT01431287 ). This post hoc analysis focuses on the T 5 µg and T/O 5/5 µg analyses. Primary efficacy end points were trough FEV1 response (ie, change from baseline) and FEV1 area under the curve from 0–3 hours (AUC0–3 ) response. Data are presented for patients by ATS category subgroups: mild (predicted FEV1 ≥50%), moderate (35 ≤ 50%) and severe (<35%), using data pooled from both of the TONADO ® studies. Results: In all disease-severity categories, the improvements in trough FEV1 and FEV1 AUC0–3 were larger with T/O compared to T alone. However, trough FEV1 and FEV1 AUC0–3 responses were generally greater in patients with mild (T/O versus T: both p < 0.0001) or moderate (T/O versus T: p < 0.001 and p < 0.0001, respectively) COPD versus those with severe COPD (T/O versus T: p < 0.01 and p < 0.0001, respectively) at baseline (Table). Treatments were well tolerated across all ATS categories and similar responses were observed in both of the studies individually. Conclusions: These data build on the analysis of the GOLD 2 population from TONADO ® and confirm that patients with mild to moderate disease derive greater benefits with T/O than with T. There was an overall trend towards greater lung-function improvement with T/O or T alone in patients with mild/moderate versus severe airflow obstruction. Funding: Boehringer Ingelheim. Reference: Buhl R, et al . Eur Respir J 2015;45 :969–979. Please refer to page A273 for declarations of interest in relation to abstract P295.