β-Blockers in COPD

Background Cardiovascular disease is a frequent comorbidity in patients with COPD. Many physicians, particularly pulmonologists, are reluctant to use β-adrenoceptor blocking agents (β-blockers) in patients with COPD, despite their proven effectiveness in preventing cardiovascular events. Methods The large (5,162 patients) phase III TONADO 1 and 2 studies assessed lung function and patient-reported outcomes in patients with moderate to very severe COPD receiving long-acting bronchodilator treatment across 1 year. This post hoc analysis characterized lung-function changes, patient-reported outcomes, and safety in the subgroup of patients receiving β-blockers in the studies. Results In total, …

P254 Once-daily Tiotropium And Olodaterol Fixed-dose Combination Via The Respimat(R) Improves Outcomes Versus Mono-components In Copd In Two 1-year Studies

Introduction Tiotropium (T), a once-daily long-acting muscarinic antagonist, is a well-established first-line maintenance treatment in chronic obstructive pulmonary disease (COPD); olodaterol (O) is a once-daily long-acting β 2 -agonist that has recently gained approval in several countries. Two Phase III replicate pivotal studies assessed the efficacy and safety of fixed-dose combinations of T and O (T+O) delivered via Respimat ® Soft Mist™ inhaler in patients with GOLD 2–4 COPD. Methods Two 52-week, double-blind, parallel-group studies randomised 5162 patients to O 5 µg, T 2.5 µg, T 5 µg, T+O 2.5/5 µg or T+O 5/5 µg. Primary efficacy end points were trough forced expiratory volume in 1 sec…

Tiotropium and olodaterol fixed-dose combination versus mono-components in COPD (GOLD 2-4).

Efficacy and safety of tiotropium+olodaterol fixed-dose combination (FDC) compared with the mono-components was evaluated in patients with moderate to very severe chronic obstructive pulmonary disease (COPD) in two replicate, randomised, double-blind, parallel-group, multicentre, phase III trials. Patients received tiotropium+olodaterol FDC 2.5/5 μg or 5/5 μg, tiotropium 2.5 μg or 5 μg, or olodaterol 5 μg delivered once-daily via Respimat inhaler over 52 weeks. Primary end points were forced expiratory volume in 1 s (FEV1) area under the curve from 0 to 3 h (AUC0–3) response, trough FEV1 response and St George's Respiratory Questionnaire (SGRQ) total score at 24 weeks. In total, 5162 patien…

Impact of grouping patients by 2017 GOLD strategy assessment criteria: a post hoc analysis of the TONADO and OTEMTO trials

Introduction: Compared to the 2014 scheme, the 2017 GOLD COPD strategy uses only symptoms and exacerbation history to group patients, and no longer gives reference to the severity of airflow limitation. Aims: This post hoc analysis of TONADO and OTEMTO data aims to determine the impact of updated assessment criteria on patient classification and characteristics within these groups. Methods: TONADO (NCT01431274/NCT01431287; N=5162) and OTEMTO (NCT01964352/NCT02006732; N=1621) Phase III trials investigated efficacy and safety of tiotropium+olodatorol fixed-dose combination in COPD patients. In this analysis, patients were classed as GOLD A–D by the 2017 or 2014 criteria. In TONADO the mMRC Dy…

The impact of grouping patients by the 2017 GOLD COPD strategy on response to therapy: post hoc results from the TONADO tiotropium+olodaterol trials

Introduction: In the 2017 GOLD COPD strategy the classification of patients by assessment of symptoms and history of exacerbation is used to guide treatment choices. The previous strategy also included lung function. Aims and objectives: To investigate the effect of the 2017 classification on an analysis of the efficacy of tiotropium+olodaterol (T+O) in GOLD stage A/B patients with COPD. Methods: Patients from the Phase III, replicate 52-week TONADO studies (NCT01431274, NCT01431287), who received T+O or the mono-components, were classed as GOLD A/B or C/D by the 2017 strategy (using exacerbation history) or 2014 strategy (using lung function and exacerbation history). Since mMRC Dyspnoea S…

P131 Efficacy of tiotropium and olodaterol combination in patients with COPD on β-blockers: Abstract P131 Table 1

Rationale The efficacy and safety of a new once-daily combination with tiotropium (T), a long-acting muscarinic antagonist, and olodaterol (O), a long-acting β2-agonist, was established for the treatment of chronic obstructive pulmonary disease (COPD) in the TONADO studies ([NCT01431274][1]; [NCT01431287][2]). This analysis evaluates the efficacy of the combination in a subpopulation of patients receiving β-blockers in these studies. Methods Two replicate, randomised, double-blind, parallel-group, 52-week, Phase III trials assessed the efficacy and safety of T+O (2.5/5 μg; 5/5 μg; via Respimat® inhaler) once daily compared to the monocomponents. Key primary end-point data for the combined a…

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

Long-Term Safety of Tiotropium/Olodaterol Respimat in Elderly Patients with Moderate to Very Severe COPD in the TONADO Studies

Efficacy of tiotropium and olodaterol fixed-dose combination in patients with COPD on β-blockers

Introduction: The efficacy and safety of a new once-daily (QD) fixed-dose combination (FDC) with tiotropium (T), a long-acting muscarinic antagonist, and olodaterol (O), a long-acting β 2 -agonist, was established for the treatment of COPD in the TONADO studies (NCT01431274; NCT01431287). This analysis evaluates the efficacy of the FDC in a subpopulation of patients receiving β-blockers (BBs) in these studies. Methods: Two replicate, randomised, double-blind, parallel-group, 52-week, Phase III trials assessed the efficacy and safety of T+O FDC (2.5/5 μg; 5/5 μg; Respimat ® inhaler) QD compared to the monocomponents. Key primary end point data for the combined analysis of the replicate trial…

P294 Benefits of tiotropium/olodaterol over tiotropium at delaying clinically significant events in patients with copd classified as gold B

Rationale The once-daily combination of tiotropium (T), a long-acting muscarinic antagonist, and olodaterol (O), a long-acting β 2 -agonist, has demonstrated efficacy and safety in COPD. Two large clinical studies (TONADO ® 1 + 2) have also demonstrated the benefits of T/O compared to the monocomponents in patients with moderate to very severe COPD. This post hoc analysis investigated whether T/O is more effective than T at delaying clinically significant events in patients with GOLD stage B COPD. Methods A total of 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 (delivered via Respimat ® inhaler) in two 52-week, parallel-group, double-blind studies (NC…