Benefits of Tiotropium + Olodaterol Over Tiotropium at Delaying Clinically Significant Events in Patients with COPD Classified as GOLD B

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Rationale: This post hoc analysis of the TONADO® 1 + 2 data investigated whether tiotropium (t) + olodaterol (o) is more effective than t at delaying clinically significant events in patients with GOLD stage B COPD (symptomatic COPD and l low risk of exacerbations). These included time to first clinically important deterioration in trough forced expiratory volume in 1 second (FEV1) or St. George's Respiratory Questionnaire (SGRQ) score, severe exacerbation, and death. Methods: 5162 patients were randomized to o 5 µg, t 2.5 µg, t 5 µg, t/o 2.5/5 µg, or t/o 5/5 µg (delivered via Respimat® inhaler) in two 52-week, parallel-group, double-blind studies (TONADO® 1 [NCT01431274] and TONADO® 2 [NCT01431287]). In this post hoc analysis of the combined TONADO® data, clinical deterioration was defined according to a composite end point: time to first decrease in trough FEV1 from baseline of >/= 100 ml; increase in SGRQ total score from baseline of >/= 4 units; severe (hospitalized) exacerbation; or death. The time to first occurrence of one of these events was recorded as the time to clinical deterioration. Only patients classified as GOLD B were included. Results: 306 and 310 patients were included in this analysis in the t 5 µg and t+o 5/5 µg treatment groups, respectively. Time to clinical deterioration was significantly longer with t+o 5/5 µg than t 5 µg (25th percentile 128 versus 85 days; hazard ratio 0.650; 95% CI 0.524, 0.805; p < 0.0001). Times to trough FEV1 decline and SGRQ increase were significantly longer with t+o 5/5 µg than t 5 µg (226 versus 91 days and 369 versus 175 days, respectively). 25th percentiles for time to severe exacerbation and time to death were not estimable due to low event rates. Conclusions: T+o increased time to clinical deterioration compared to t alone in patients with GOLD stage B disease. This suggests that in this patient population t+o is more effective than t in preventing these significant events. Content already presented at ATS congress 2016

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