Is the combination of tiotropium/olodaterol proven more effective in reducing the risk of clinically significant worsening of COPD compared to monotherapy?

Definition of clinically significant worsening of COPD

A recently published post hoc analysis of the TONADO 1 and 2 studies evaluated the time to the occurrence of the first event demonstrating clinically significant worsening of COPD. The effectiveness of the fixed combination of the long-acting muscarinic antagonist (LAMA) tiotropium and the long-acting β₂-agonist (LABA) olodaterol was compared with LAMA alone. Clinically significant worsening of COPD was defined as a decrease in the baseline one-second vital capacity (FEV₁) by ≥ 0.1 L, an increase in the quality of life questionnaire St. George's Respiratory Questionnaire score by ≥ 4 points compared to baseline, or the occurrence of moderate/severe exacerbation.

Patient population studied

Data from 2055 patients with moderate to severe COPD who, within 2 double-blind studies, took either tiotropium/olodaterol at a dose of 5/5 µg, or tiotropium at a dose of 5 µg, always using the Respimat^® inhaler, for 1 year were analyzed.

Findings

The results showed a significant prolongation of the time to clinically significant worsening of COPD with combination therapy compared to monotherapy: the median time to the occurrence of the first event of the composite endpoint was 226 vs. 169 days (hazard ratio [HR] 0.76; 95% confidence interval [CI] 0.68–0.85; p < 0.0001).

This benefit of the combination of tiotropium/olodaterol compared to tiotropium alone was observed not only in the overall study population but also in patients at earlier stages of COPD (with up to 1 moderate exacerbation), with GOLD class 2, or those who had not yet used maintenance therapy.

Conclusion

The results indicate that early optimization of COPD treatment and the use of a fixed combination of tiotropium/olodaterol is more effective in delaying clinically significant worsening of COPD than tiotropium monotherapy.

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Source:

Rabe K. F., Chalmers J. D., Miravitlles M. et al. Tiotropium/olodaterol delays clinically important deterioration compared with tiotropium monotherapy in patients with early COPD: a post hoc analysis of the TONADO^®trials. Adv Ther 2021 Jan; 38 (1): 579−593, doi: 10.1007/s12325-020-01528-2.