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RESEARCH PRODUCT

The effect of tiotropium/olodaterol versus tiotropium on COPD exacerbation rates in patients with/without frequent exacerbation history

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Background: Patients with COPD with a history of frequent exacerbations are at increased risk of future exacerbations. There are limited data as to whether combining LAMA/LABA reduces exacerbation risk in all patients. We investigated whether tiotropium/olodaterol (T/O) reduced exacerbation rate versus tiotropium (tio) in patients with a range of exacerbation histories. Methods: TONADO 1+2 (NCT01431274/NCT01431287) and DYNAGITO (NCT02296138) were 52-week, parallel-group, randomised, double-blind, Phase III trials in COPD patients with FEV1 Results: There was a lower rate of moderate/severe exacerbations with T/O (0.68 per patient-year) than tio (0.77 per patient-year) (rate ratio [RR] vs tio: 0.89; 95% CI: 0.84, 0.95; P=0.0003) (Figure). Similar results were seen regardless of exacerbation history. There were fewer hospitalised exacerbations with T/O (0.11 per patient-year) than tio (0.13 per patient-year) (RR vs tio: 0.86; 95% CI: 0.75, 0.99; P=0.0380) (Figure). Conclusions: This post hoc pooled analysis of a heterogeneous population of over 9900 COPD patients reflects patients seen in clinical practice. Treatment with T/O reduced exacerbation rate compared with tio, independent of the patient’s exacerbation history.