In patients with chronic obstructive pulmonary disease (COPD), the use of tiotropium/olodaterol 5/5 µg was associated with lower rates of moderate to severe exacerbations and exacerbations requiring hospitalization compared with the use of tiotropium 5 µg alone.
A post hoc analysis of pooled data from three 52-week, phase 3, parallel-group, randomized, double-blind trials — TONADO® 1 (ClinicalTrials.gov identifier: NCT01431274), TONADO® 2 (ClinicalTrials.gov Identifier: NCT01431287), and DYNAGITO® (ClinicalTrials.gov Identifier: NCT02296138) — was conducted. Results of the study were published in the journal Advances in Therapy.
Investigators sought to evaluate the effect of tiotropium/olodaterol vs tiotropium alone on moderate to severe exacerbations of COPD and exacerbations leading to hospitalization in the following patient subgroups: (1) those with a low exacerbation history (ie, 0 to 1 moderate exacerbation in the previous 12 months) and a high exacerbation history (ie, ≥2 moderate or ≥1 severe exacerbation in the previous
12 months); (2) those with an exacerbation history based on 0 or 1 exacerbation in the previous 12 months; (3) Global Initiative for Chronic Obstructive Lung Disease (GOLD) stage 2, 3, and 4; and (4) those individuals with and without baseline inhaled corticosteroid use.
In this post hoc analysis, a total of 9942 participants were randomized to receive treatment with either tiotropium/olodaterol (n=4968) or tiotropium alone (n=4974). All participants were ≥ aged 40 years. The majority of the patients were men (tiotropium alone, 72.3%; tiotropium/olodaterol, 70.8%). More than one-third of the participants were former smokers.
Results of the analysis showed that the use of tiotropium/olodaterol was associated with significantly lower rates of moderate to severe exacerbations (0.68 vs 0.77 per patient-year, respectively; rate ratio [RR] vs tiotropium alone, 0.89; 95% CI, 0.84-0.95; P =.0003), as well as exacerbations requiring hospitalization (0.11 vs 0.13 per patient-year, respectively; RR, 0.86; 95% CI, 0.75-0.99; P =.0380) vs tiotropium alone.
The investigators concluded that the findings from this study support the growing body of evidence that demonstrates the benefits of dual bronchodilation with tiotropium/ olodaterol — that is, a long-acting muscarinic antagonist plus a long-acting β2-agonist — in patients with COPD.
Disclosure: Several study authors declared affiliations with the pharmaceutical industry. Please see the original reference for a full list of authors’ disclosures.
Wedzicha JA, Buhl R, Singh D, et al. Tiotropium/olodaterol decreases exacerbation rates compared with tiotropium in a range of patients with COPD: pooled analysis of the TONADO®/DYNAGITO® trials. Adv Ther. Published online August 20, 2020. doi:10.1007/s12325-020-01438-3