Tiotropium

14,000,000 Leading Edge Experts on the ideXlab platform

Scan Science and Technology

Contact Leading Edge Experts & Companies

Scan Science and Technology

Contact Leading Edge Experts & Companies

The Experts below are selected from a list of 7170 Experts worldwide ranked by ideXlab platform

Roland Buhl - One of the best experts on this subject based on the ideXlab platform.

  • Tiotropium/Olodaterol Decreases Exacerbation Rates Compared with Tiotropium in a Range of Patients with COPD: Pooled Analysis of the TONADO^®/DYNAGITO^® Trials
    Advances in Therapy, 2020
    Co-Authors: Jadwiga A Wedzicha, Roland Buhl, Antonio Anzueto, Dave Singh, Claus F Vogelmeier, Peter M A Calverley
    Abstract:

    Introduction Previous studies demonstrated that Tiotropium/olodaterol reduced rates of exacerbations in patients with chronic obstructive pulmonary disease (COPD). However, this should be examined in a wider population. Methods This post hoc analysis pooled data from TONADO^® 1 + 2 and DYNAGITO^®, three 52-week, parallel-group, randomised, double-blind, phase III trials investigating patients with moderate-to-very severe COPD, with and without previous exacerbations, who received Tiotropium/olodaterol 5/5 µg or Tiotropium 5 µg. Subgroup analyses were conducted on patients stratified by exacerbation history, Global Initiative for Chronic Obstructive Lung Disease (GOLD) stage 2–4 disease severity and baseline inhaled corticosteroid (ICS) use. Results In 9942 patients, Tiotropium/olodaterol was associated with lower rates of moderate/severe exacerbations (0.68 vs. 0.77 per patient-year; rate ratio (RR) vs. Tiotropium 0.89, 95% confidence interval (CI) 0.84, 0.95; P  = 0.0003) and exacerbations requiring hospitalisation (0.11 vs. 0.13 per patient-year; RR 0.86, 95% CI 0.75, 0.99; P  = 0.0380) versus Tiotropium. Lower rates of moderate/severe exacerbations with Tiotropium/olodaterol versus Tiotropium were evident in patients with 0–1 moderate exacerbation in the previous year (0.54 vs. 0.60 per patient-year; RR 0.90, 95% CI 0.82, 0.98; P  = 0.0187) and at least two moderate or at least one severe exacerbation(s) in the previous year (0.97 vs. 1.09 per patient-year; RR 0.89, 95% CI 0.82, 0.97; P  = 0.0096). In patients with GOLD 2 and GOLD 3 COPD, moderate/severe exacerbation rates were lower with Tiotropium/olodaterol versus Tiotropium; GOLD 4 patients showed negligible difference between treatments. When evaluating patients by baseline ICS use, there was a significantly lower rate of moderate/severe exacerbations with Tiotropium/olodaterol versus Tiotropium in patients receiving ICS. Conclusions Tiotropium/olodaterol decreased the rate of moderate/severe exacerbations and exacerbations leading to hospitalisation versus Tiotropium. Results from this large, pooled, post hoc analysis support the use of dual bronchodilation with Tiotropium/olodaterol in a broad range of patients, reflective of patients with COPD in clinical practice. Trial Registration TONADO^® 1 (ClinicalTrials.gov: NCT01431274); TONADO^® 2 (ClinicalTrials.gov: NCT01431287); DYNAGITO^® (ClinicalTrials.gov: NCT02296138). Plain Language Summary People with chronic obstructive pulmonary disease (COPD) may have times when their symptoms worsen, known as exacerbations. This may mean that they need to take additional medications, such as antibiotics or oral steroids. Studies have shown that a combination of two types of inhaled medicine—Tiotropium and olodaterol—can help to reduce exacerbations in some people. To see if this is also the case across a larger and more diverse range of people, we combined the results from three studies (TONADO^® 1 + 2 and DYNAGITO^®) that looked at people who were taking Tiotropium and olodaterol together and people who were taking Tiotropium alone. We showed that, across a wide range of people, treatment with Tiotropium/olodaterol was generally better at reducing exacerbations than Tiotropium. Tiotropium/olodaterol also decreased the number of exacerbations that led to hospitalisation compared with Tiotropium. Overall, our results support the use of combined Tiotropium/olodaterol in people at different stages of COPD. Graphical Abstract

  • Tiotropium/Olodaterol Decreases Exacerbation Rates Compared with Tiotropium in a Range of Patients with COPD: Pooled Analysis of the TONADO®/DYNAGITO® Trials.
    Advances in therapy, 2020
    Co-Authors: Jadwiga A Wedzicha, Roland Buhl, Antonio Anzueto, Dave Singh, Claus F Vogelmeier, Peter M A Calverley
    Abstract:

    Previous studies demonstrated that Tiotropium/olodaterol reduced rates of exacerbations in patients with chronic obstructive pulmonary disease (COPD). However, this should be examined in a wider population. This post hoc analysis pooled data from TONADO® 1 + 2 and DYNAGITO®, three 52-week, parallel-group, randomised, double-blind, phase III trials investigating patients with moderate-to-very severe COPD, with and without previous exacerbations, who received Tiotropium/olodaterol 5/5 µg or Tiotropium 5 µg. Subgroup analyses were conducted on patients stratified by exacerbation history, Global Initiative for Chronic Obstructive Lung Disease (GOLD) stage 2-4 disease severity and baseline inhaled corticosteroid (ICS) use. In 9942 patients, Tiotropium/olodaterol was associated with lower rates of moderate/severe exacerbations (0.68 vs. 0.77 per patient-year; rate ratio (RR) vs. Tiotropium 0.89, 95% confidence interval (CI) 0.84, 0.95; P = 0.0003) and exacerbations requiring hospitalisation (0.11 vs. 0.13 per patient-year; RR 0.86, 95% CI 0.75, 0.99; P = 0.0380) versus Tiotropium. Lower rates of moderate/severe exacerbations with Tiotropium/olodaterol versus Tiotropium were evident in patients with 0-1 moderate exacerbation in the previous year (0.54 vs. 0.60 per patient-year; RR 0.90, 95% CI 0.82, 0.98; P = 0.0187) and at least two moderate or at least one severe exacerbation(s) in the previous year (0.97 vs. 1.09 per patient-year; RR 0.89, 95% CI 0.82, 0.97; P = 0.0096). In patients with GOLD 2 and GOLD 3 COPD, moderate/severe exacerbation rates were lower with Tiotropium/olodaterol versus Tiotropium; GOLD 4 patients showed negligible difference between treatments. When evaluating patients by baseline ICS use, there was a significantly lower rate of moderate/severe exacerbations with Tiotropium/olodaterol versus Tiotropium in patients receiving ICS. Tiotropium/olodaterol decreased the rate of moderate/severe exacerbations and exacerbations leading to hospitalisation versus Tiotropium. Results from this large, pooled, post hoc analysis support the use of dual bronchodilation with Tiotropium/olodaterol in a broad range of patients, reflective of patients with COPD in clinical practice. TONADO® 1 (ClinicalTrials.gov: NCT01431274); TONADO® 2 (ClinicalTrials.gov: NCT01431287); DYNAGITO® (ClinicalTrials.gov: NCT02296138). People with chronic obstructive pulmonary disease (COPD) may have times when their symptoms worsen, known as exacerbations. This may mean that they need to take additional medications, such as antibiotics or oral steroids. Studies have shown that a combination of two types of inhaled medicine-Tiotropium and olodaterol-can help to reduce exacerbations in some people. To see if this is also the case across a larger and more diverse range of people, we combined the results from three studies (TONADO® 1 + 2 and DYNAGITO®) that looked at people who were taking Tiotropium and olodaterol together and people who were taking Tiotropium alone. We showed that, across a wide range of people, treatment with Tiotropium/olodaterol was generally better at reducing exacerbations than Tiotropium. Tiotropium/olodaterol also decreased the number of exacerbations that led to hospitalisation compared with Tiotropium. Overall, our results support the use of combined Tiotropium/olodaterol in people at different stages of COPD.

  • Benefits of Tiotropium/Olodaterol Compared with Tiotropium in Patients with COPD Receiving only LAMA at Baseline: Pooled Analysis of the TONADO^® and OTEMTO^® Studies
    Advances in Therapy, 2020
    Co-Authors: Roland Buhl, Dave Singh, Gary T Ferguson
    Abstract:

    Introduction The Global Initiative for Chronic Obstructive Lung Disease (GOLD) strategy report recommends long-acting muscarinic antagonists (LAMA) or long-acting β_2-agonists (LABA) as first-line treatment for chronic obstructive pulmonary disease (COPD), but many patients remain symptomatic on monotherapy and escalation to dual-bronchodilator therapy may be warranted. Methods TONADO^® 1&2 and OTEMTO^® 1&2 assessed lung function and patient-reported outcomes in patients with moderate-to-severe (OTEMTO) or moderate-to-very-severe (TONADO) COPD. This pooled post hoc analysis included patients treated with LAMA monotherapy at baseline who were randomised to receive either 5 µg Tiotropium (LAMA) or 5/5 µg Tiotropium/olodaterol (LAMA/LABA). We assessed changes from baseline and responder rates for trough forced expiratory volume in 1 s (FEV_1), St. George’s Respiratory Questionnaire (SGRQ) and the Transition Dyspnoea Index (TDI). Results Overall, 151 patients received Tiotropium; 148 received Tiotropium/olodaterol. Mean differences from baseline with Tiotropium/olodaterol versus Tiotropium were + 0.074 l (95% confidence interval [CI] 0.033, 0.115; P  = 0.0004) for trough FEV_1, − 2.675 (95% CI − 5.060, − 0.291; P  = 0.0280) for SGRQ and 1.148 (95% CI 0.564, 1.732; P  = 0.0001) for TDI. Patients were more likely to respond when treated with Tiotropium/olodaterol versus Tiotropium for trough FEV_1 (odds ratio [OR] 3.14, 95% CI 1.94, 5.06; P  

  • Efficacy of Tiotropium/Olodaterol Compared with Tiotropium as a First-Line Maintenance Treatment in Patients with COPD Who Are Naïve to LAMA, LABA and ICS: Pooled Analysis of Four Clinical Trials
    Advances in Therapy, 2020
    Co-Authors: Roland Buhl, Dave Singh, Gary T Ferguson
    Abstract:

    People with chronic obstructive pulmonary disease (COPD) often have problems breathing, which can make it difficult to carry out daily physical tasks. Bronchodilators are a type of medication that relax the muscles in the lungs and widen airways, making it easier to breathe. Evidence suggests that using a combination of two different bronchodilators is more effective than using one bronchodilator on its own. In this article, we look at four large studies that compared the effects of at least 12 weeks of treatment with two bronchodilators (Tiotropium/olodaterol) with Tiotropium on its own in people who had not received any previous medication for their COPD. The results suggest that people who were treated with Tiotropium and olodaterol together had significantly better improvements in lung function, quality of life and breathlessness after 12 weeks than those taking Tiotropium alone, without compromising safety. Overall, people treated with Tiotropium/olodaterol were 60% more likely to experience a meaningful improvement in at least one of these areas compared with those on Tiotropium alone. These results support the use of Tiotropium and olodaterol together as a first medication for COPD. Introduction The efficacy of Tiotropium/olodaterol compared with Tiotropium in patients with chronic obstructive pulmonary disease (COPD) has been demonstrated in a large clinical programme. Currently, randomised controlled trial (RCT) data on dual bronchodilation as first-line maintenance therapy are limited. In this post hoc analysis of pooled data from four RCTs, we compared the efficacy of Tiotropium/olodaterol versus Tiotropium as maintenance therapy in patients with COPD who were not receiving maintenance treatment with long-acting muscarinic antagonists (LAMAs), long-acting β_2-agonists (LABAs) or inhaled corticosteroids (ICS) (“maintenance naïve”) at study entry. Methods TONADO^® 1/2 (52 weeks) and OTEMTO^® 1/2 (12 weeks) were phase III RCTs in patients with COPD. TONADO 1/2 and OTEMTO 1/2 enrolled patients with post-bronchodilator forced expiratory volume in 1 s (FEV_1) 

  • benefits of Tiotropium olodaterol compared with Tiotropium in patients with copd receiving only lama at baseline pooled analysis of the tonado and otemto studies
    Advances in Therapy, 2020
    Co-Authors: Roland Buhl, Dave Singh, Gary T Ferguson
    Abstract:

    INTRODUCTION The Global Initiative for Chronic Obstructive Lung Disease (GOLD) strategy report recommends long-acting muscarinic antagonists (LAMA) or long-acting β2-agonists (LABA) as first-line treatment for chronic obstructive pulmonary disease (COPD), but many patients remain symptomatic on monotherapy and escalation to dual-bronchodilator therapy may be warranted. METHODS TONADO® 1&2 and OTEMTO® 1&2 assessed lung function and patient-reported outcomes in patients with moderate-to-severe (OTEMTO) or moderate-to-very-severe (TONADO) COPD. This pooled post hoc analysis included patients treated with LAMA monotherapy at baseline who were randomised to receive either 5 µg Tiotropium (LAMA) or 5/5 µg Tiotropium/olodaterol (LAMA/LABA). We assessed changes from baseline and responder rates for trough forced expiratory volume in 1 s (FEV1), St. George's Respiratory Questionnaire (SGRQ) and the Transition Dyspnoea Index (TDI). RESULTS Overall, 151 patients received Tiotropium; 148 received Tiotropium/olodaterol. Mean differences from baseline with Tiotropium/olodaterol versus Tiotropium were + 0.074 l (95% confidence interval [CI] 0.033, 0.115; P = 0.0004) for trough FEV1, - 2.675 (95% CI - 5.060, - 0.291; P = 0.0280) for SGRQ and 1.148 (95% CI 0.564, 1.732; P = 0.0001) for TDI. Patients were more likely to respond when treated with Tiotropium/olodaterol versus Tiotropium for trough FEV1 (odds ratio [OR] 3.14, 95% CI 1.94, 5.06; P < 0.0001), SGRQ (OR 1.49, 95% CI 0.93, 2.40; P = 0.0980) and TDI (OR 2.81, 95% CI 1.71, 4.60; P < 0.0001). Minimum clinically important difference from baseline in any of the analysed outcomes (FEV1 ≥ 0.1 l, SGRQ ≥ 4.0 points or TDI ≥ 1.0 point) was more likely in patients treated with Tiotropium/olodaterol versus Tiotropium (OR 2.43, 95% CI 1.32, 4.51; P = 0.0046). CONCLUSION In patients with COPD receiving only LAMA monotherapy, treatment escalation to Tiotropium/olodaterol resulted in statistically significant and clinically relevant improvements in lung function, health status and breathlessness. These results support early therapy optimisation to dual bronchodilation with Tiotropium/olodaterol in patients receiving Tiotropium alone. TRIAL REGISTRATION TONADO® 1 was registered in the US National Library of Medicine on 9 September 2011 (Clinicaltrials.gov: NCT01431274). TONADO® 2 was registered in the US National Library of Medicine on 9 September 2011 (Clinicaltrials.gov: NCT01431287). OTEMTO® 1 was registered in the US National Library of Medicine on 17 October 2013 (Clinicaltrials.gov: NCT01964352). OTEMTO® 2 was registered in the US National Library of Medicine on 10 December 2013 (Clinicaltrials.gov: NCT02006732).

Peter M A Calverley - One of the best experts on this subject based on the ideXlab platform.

  • Tiotropium/Olodaterol Decreases Exacerbation Rates Compared with Tiotropium in a Range of Patients with COPD: Pooled Analysis of the TONADO®/DYNAGITO® Trials.
    Advances in therapy, 2020
    Co-Authors: Jadwiga A Wedzicha, Roland Buhl, Antonio Anzueto, Dave Singh, Claus F Vogelmeier, Peter M A Calverley
    Abstract:

    Previous studies demonstrated that Tiotropium/olodaterol reduced rates of exacerbations in patients with chronic obstructive pulmonary disease (COPD). However, this should be examined in a wider population. This post hoc analysis pooled data from TONADO® 1 + 2 and DYNAGITO®, three 52-week, parallel-group, randomised, double-blind, phase III trials investigating patients with moderate-to-very severe COPD, with and without previous exacerbations, who received Tiotropium/olodaterol 5/5 µg or Tiotropium 5 µg. Subgroup analyses were conducted on patients stratified by exacerbation history, Global Initiative for Chronic Obstructive Lung Disease (GOLD) stage 2-4 disease severity and baseline inhaled corticosteroid (ICS) use. In 9942 patients, Tiotropium/olodaterol was associated with lower rates of moderate/severe exacerbations (0.68 vs. 0.77 per patient-year; rate ratio (RR) vs. Tiotropium 0.89, 95% confidence interval (CI) 0.84, 0.95; P = 0.0003) and exacerbations requiring hospitalisation (0.11 vs. 0.13 per patient-year; RR 0.86, 95% CI 0.75, 0.99; P = 0.0380) versus Tiotropium. Lower rates of moderate/severe exacerbations with Tiotropium/olodaterol versus Tiotropium were evident in patients with 0-1 moderate exacerbation in the previous year (0.54 vs. 0.60 per patient-year; RR 0.90, 95% CI 0.82, 0.98; P = 0.0187) and at least two moderate or at least one severe exacerbation(s) in the previous year (0.97 vs. 1.09 per patient-year; RR 0.89, 95% CI 0.82, 0.97; P = 0.0096). In patients with GOLD 2 and GOLD 3 COPD, moderate/severe exacerbation rates were lower with Tiotropium/olodaterol versus Tiotropium; GOLD 4 patients showed negligible difference between treatments. When evaluating patients by baseline ICS use, there was a significantly lower rate of moderate/severe exacerbations with Tiotropium/olodaterol versus Tiotropium in patients receiving ICS. Tiotropium/olodaterol decreased the rate of moderate/severe exacerbations and exacerbations leading to hospitalisation versus Tiotropium. Results from this large, pooled, post hoc analysis support the use of dual bronchodilation with Tiotropium/olodaterol in a broad range of patients, reflective of patients with COPD in clinical practice. TONADO® 1 (ClinicalTrials.gov: NCT01431274); TONADO® 2 (ClinicalTrials.gov: NCT01431287); DYNAGITO® (ClinicalTrials.gov: NCT02296138). People with chronic obstructive pulmonary disease (COPD) may have times when their symptoms worsen, known as exacerbations. This may mean that they need to take additional medications, such as antibiotics or oral steroids. Studies have shown that a combination of two types of inhaled medicine-Tiotropium and olodaterol-can help to reduce exacerbations in some people. To see if this is also the case across a larger and more diverse range of people, we combined the results from three studies (TONADO® 1 + 2 and DYNAGITO®) that looked at people who were taking Tiotropium and olodaterol together and people who were taking Tiotropium alone. We showed that, across a wide range of people, treatment with Tiotropium/olodaterol was generally better at reducing exacerbations than Tiotropium. Tiotropium/olodaterol also decreased the number of exacerbations that led to hospitalisation compared with Tiotropium. Overall, our results support the use of combined Tiotropium/olodaterol in people at different stages of COPD.

  • Tiotropium/Olodaterol Decreases Exacerbation Rates Compared with Tiotropium in a Range of Patients with COPD: Pooled Analysis of the TONADO^®/DYNAGITO^® Trials
    Advances in Therapy, 2020
    Co-Authors: Jadwiga A Wedzicha, Roland Buhl, Antonio Anzueto, Dave Singh, Claus F Vogelmeier, Peter M A Calverley
    Abstract:

    Introduction Previous studies demonstrated that Tiotropium/olodaterol reduced rates of exacerbations in patients with chronic obstructive pulmonary disease (COPD). However, this should be examined in a wider population. Methods This post hoc analysis pooled data from TONADO^® 1 + 2 and DYNAGITO^®, three 52-week, parallel-group, randomised, double-blind, phase III trials investigating patients with moderate-to-very severe COPD, with and without previous exacerbations, who received Tiotropium/olodaterol 5/5 µg or Tiotropium 5 µg. Subgroup analyses were conducted on patients stratified by exacerbation history, Global Initiative for Chronic Obstructive Lung Disease (GOLD) stage 2–4 disease severity and baseline inhaled corticosteroid (ICS) use. Results In 9942 patients, Tiotropium/olodaterol was associated with lower rates of moderate/severe exacerbations (0.68 vs. 0.77 per patient-year; rate ratio (RR) vs. Tiotropium 0.89, 95% confidence interval (CI) 0.84, 0.95; P  = 0.0003) and exacerbations requiring hospitalisation (0.11 vs. 0.13 per patient-year; RR 0.86, 95% CI 0.75, 0.99; P  = 0.0380) versus Tiotropium. Lower rates of moderate/severe exacerbations with Tiotropium/olodaterol versus Tiotropium were evident in patients with 0–1 moderate exacerbation in the previous year (0.54 vs. 0.60 per patient-year; RR 0.90, 95% CI 0.82, 0.98; P  = 0.0187) and at least two moderate or at least one severe exacerbation(s) in the previous year (0.97 vs. 1.09 per patient-year; RR 0.89, 95% CI 0.82, 0.97; P  = 0.0096). In patients with GOLD 2 and GOLD 3 COPD, moderate/severe exacerbation rates were lower with Tiotropium/olodaterol versus Tiotropium; GOLD 4 patients showed negligible difference between treatments. When evaluating patients by baseline ICS use, there was a significantly lower rate of moderate/severe exacerbations with Tiotropium/olodaterol versus Tiotropium in patients receiving ICS. Conclusions Tiotropium/olodaterol decreased the rate of moderate/severe exacerbations and exacerbations leading to hospitalisation versus Tiotropium. Results from this large, pooled, post hoc analysis support the use of dual bronchodilation with Tiotropium/olodaterol in a broad range of patients, reflective of patients with COPD in clinical practice. Trial Registration TONADO^® 1 (ClinicalTrials.gov: NCT01431274); TONADO^® 2 (ClinicalTrials.gov: NCT01431287); DYNAGITO^® (ClinicalTrials.gov: NCT02296138). Plain Language Summary People with chronic obstructive pulmonary disease (COPD) may have times when their symptoms worsen, known as exacerbations. This may mean that they need to take additional medications, such as antibiotics or oral steroids. Studies have shown that a combination of two types of inhaled medicine—Tiotropium and olodaterol—can help to reduce exacerbations in some people. To see if this is also the case across a larger and more diverse range of people, we combined the results from three studies (TONADO^® 1 + 2 and DYNAGITO^®) that looked at people who were taking Tiotropium and olodaterol together and people who were taking Tiotropium alone. We showed that, across a wide range of people, treatment with Tiotropium/olodaterol was generally better at reducing exacerbations than Tiotropium. Tiotropium/olodaterol also decreased the number of exacerbations that led to hospitalisation compared with Tiotropium. Overall, our results support the use of combined Tiotropium/olodaterol in people at different stages of COPD. Graphical Abstract

  • Tiotropium olodaterol decreases exacerbation rates compared with Tiotropium in a range of patients with copd pooled analysis of the tonado dynagito trials
    Advances in Therapy, 2020
    Co-Authors: Jadwiga A Wedzicha, Antonio Anzueto, Dave Singh, Claus F Vogelmeier, R Buhl, Peter M A Calverley
    Abstract:

    INTRODUCTION Previous studies demonstrated that Tiotropium/olodaterol reduced rates of exacerbations in patients with chronic obstructive pulmonary disease (COPD). However, this should be examined in a wider population. METHODS This post hoc analysis pooled data from TONADO® 1 + 2 and DYNAGITO®, three 52-week, parallel-group, randomised, double-blind, phase III trials investigating patients with moderate-to-very severe COPD, with and without previous exacerbations, who received Tiotropium/olodaterol 5/5 µg or Tiotropium 5 µg. Subgroup analyses were conducted on patients stratified by exacerbation history, Global Initiative for Chronic Obstructive Lung Disease (GOLD) stage 2-4 disease severity and baseline inhaled corticosteroid (ICS) use. RESULTS In 9942 patients, Tiotropium/olodaterol was associated with lower rates of moderate/severe exacerbations (0.68 vs. 0.77 per patient-year; rate ratio (RR) vs. Tiotropium 0.89, 95% confidence interval (CI) 0.84, 0.95; P = 0.0003) and exacerbations requiring hospitalisation (0.11 vs. 0.13 per patient-year; RR 0.86, 95% CI 0.75, 0.99; P = 0.0380) versus Tiotropium. Lower rates of moderate/severe exacerbations with Tiotropium/olodaterol versus Tiotropium were evident in patients with 0-1 moderate exacerbation in the previous year (0.54 vs. 0.60 per patient-year; RR 0.90, 95% CI 0.82, 0.98; P = 0.0187) and at least two moderate or at least one severe exacerbation(s) in the previous year (0.97 vs. 1.09 per patient-year; RR 0.89, 95% CI 0.82, 0.97; P = 0.0096). In patients with GOLD 2 and GOLD 3 COPD, moderate/severe exacerbation rates were lower with Tiotropium/olodaterol versus Tiotropium; GOLD 4 patients showed negligible difference between treatments. When evaluating patients by baseline ICS use, there was a significantly lower rate of moderate/severe exacerbations with Tiotropium/olodaterol versus Tiotropium in patients receiving ICS. CONCLUSIONS Tiotropium/olodaterol decreased the rate of moderate/severe exacerbations and exacerbations leading to hospitalisation versus Tiotropium. Results from this large, pooled, post hoc analysis support the use of dual bronchodilation with Tiotropium/olodaterol in a broad range of patients, reflective of patients with COPD in clinical practice. TRIAL REGISTRATION TONADO® 1 (ClinicalTrials.gov: NCT01431274); TONADO® 2 (ClinicalTrials.gov: NCT01431287); DYNAGITO® (ClinicalTrials.gov: NCT02296138). People with chronic obstructive pulmonary disease (COPD) may have times when their symptoms worsen, known as exacerbations. This may mean that they need to take additional medications, such as antibiotics or oral steroids. Studies have shown that a combination of two types of inhaled medicine-Tiotropium and olodaterol-can help to reduce exacerbations in some people. To see if this is also the case across a larger and more diverse range of people, we combined the results from three studies (TONADO® 1 + 2 and DYNAGITO®) that looked at people who were taking Tiotropium and olodaterol together and people who were taking Tiotropium alone. We showed that, across a wide range of people, treatment with Tiotropium/olodaterol was generally better at reducing exacerbations than Tiotropium. Tiotropium/olodaterol also decreased the number of exacerbations that led to hospitalisation compared with Tiotropium. Overall, our results support the use of combined Tiotropium/olodaterol in people at different stages of COPD.

  • safety of Tiotropium olodaterol in chronic obstructive pulmonary disease pooled analysis of three large 52 week randomized clinical trials
    Respiratory Medicine, 2018
    Co-Authors: Gary T Ferguson, Roland Buhl, Antonio Anzueto, Ulrich Bothner, Peter M A Calverley
    Abstract:

    Abstract Background An extensive clinical trial program supports the efficacy and safety of Tiotropium/olodaterol in chronic obstructive pulmonary disease (COPD). We examined the safety of Tiotropium/olodaterol compared with Tiotropium in a large population of patients, focusing on cardiovascular and respiratory events. Methods Patients (n = 9942) who received once-daily Tiotropium/olodaterol 5/5 μg or Tiotropium 5 μg (via Respimat®) in TONADO 1 & 2 and DYNAGITO were included. The number of patients and exposure-adjusted rate of events are presented for adverse events (AEs), serious AEs (SAEs), AEs leading to discontinuation, and cardiovascular and respiratory events. Findings Fewer patients discontinued due to AEs with Tiotropium/olodaterol (5.9%) versus Tiotropium (7.9%; rate ratio [RR] 0.72; 95% confidence interval [CI] 0.62–0.84). There was no significant difference in the incidence of AEs, SAEs, cardiovascular AEs or central nervous system vascular AEs between treatments. Incidences of major adverse cardiovascular events (MACE) were 2.11 per 100 patient-years with Tiotropium/olodaterol and 2.22 with Tiotropium (RR 0.95; 95% CI 0.72–1.25), and incidences of fatal MACE (including death with undetermined cause) were 0.91 and 1.00 per 100 patient-years with Tiotropium/olodaterol and Tiotropium, respectively (RR 0.91; 95% CI 0.60–1.37). Respiratory AEs were generally balanced between treatment groups. Conclusions These results provide robust evidence that the benefits of Tiotropium/olodaterol versus Tiotropium are not at the expense of an increased risk of safety events. The combination is a suitable option for patients with COPD, even in the presence of cardiovascular risk factors. Clinical trials registration clinicaltrials. gov (TONADO 1 and 2: NCT01431274, NCT01431287; DYNAGITO: NCT02296138).

  • Safety of Tiotropium/olodaterol in chronic obstructive pulmonary disease: pooled analysis of three large, 52-week, randomized clinical trials.
    Respiratory Medicine, 2018
    Co-Authors: Gary T Ferguson, Roland Buhl, Antonio Anzueto, Florian Voß, Ulrich Bothner, Peter M A Calverley
    Abstract:

    Abstract Background An extensive clinical trial program supports the efficacy and safety of Tiotropium/olodaterol in chronic obstructive pulmonary disease (COPD). We examined the safety of Tiotropium/olodaterol compared with Tiotropium in a large population of patients, focusing on cardiovascular and respiratory events. Methods Patients (n = 9942) who received once-daily Tiotropium/olodaterol 5/5 μg or Tiotropium 5 μg (via Respimat®) in TONADO 1 & 2 and DYNAGITO were included. The number of patients and exposure-adjusted rate of events are presented for adverse events (AEs), serious AEs (SAEs), AEs leading to discontinuation, and cardiovascular and respiratory events. Findings Fewer patients discontinued due to AEs with Tiotropium/olodaterol (5.9%) versus Tiotropium (7.9%; rate ratio [RR] 0.72; 95% confidence interval [CI] 0.62–0.84). There was no significant difference in the incidence of AEs, SAEs, cardiovascular AEs or central nervous system vascular AEs between treatments. Incidences of major adverse cardiovascular events (MACE) were 2.11 per 100 patient-years with Tiotropium/olodaterol and 2.22 with Tiotropium (RR 0.95; 95% CI 0.72–1.25), and incidences of fatal MACE (including death with undetermined cause) were 0.91 and 1.00 per 100 patient-years with Tiotropium/olodaterol and Tiotropium, respectively (RR 0.91; 95% CI 0.60–1.37). Respiratory AEs were generally balanced between treatment groups. Conclusions These results provide robust evidence that the benefits of Tiotropium/olodaterol versus Tiotropium are not at the expense of an increased risk of safety events. The combination is a suitable option for patients with COPD, even in the presence of cardiovascular risk factors. Clinical trials registration clinicaltrials. gov (TONADO 1 and 2: NCT01431274, NCT01431287; DYNAGITO: NCT02296138).

Gary T Ferguson - One of the best experts on this subject based on the ideXlab platform.

  • Benefits of Tiotropium/Olodaterol Compared with Tiotropium in Patients with COPD Receiving only LAMA at Baseline: Pooled Analysis of the TONADO^® and OTEMTO^® Studies
    Advances in Therapy, 2020
    Co-Authors: Roland Buhl, Dave Singh, Gary T Ferguson
    Abstract:

    Introduction The Global Initiative for Chronic Obstructive Lung Disease (GOLD) strategy report recommends long-acting muscarinic antagonists (LAMA) or long-acting β_2-agonists (LABA) as first-line treatment for chronic obstructive pulmonary disease (COPD), but many patients remain symptomatic on monotherapy and escalation to dual-bronchodilator therapy may be warranted. Methods TONADO^® 1&2 and OTEMTO^® 1&2 assessed lung function and patient-reported outcomes in patients with moderate-to-severe (OTEMTO) or moderate-to-very-severe (TONADO) COPD. This pooled post hoc analysis included patients treated with LAMA monotherapy at baseline who were randomised to receive either 5 µg Tiotropium (LAMA) or 5/5 µg Tiotropium/olodaterol (LAMA/LABA). We assessed changes from baseline and responder rates for trough forced expiratory volume in 1 s (FEV_1), St. George’s Respiratory Questionnaire (SGRQ) and the Transition Dyspnoea Index (TDI). Results Overall, 151 patients received Tiotropium; 148 received Tiotropium/olodaterol. Mean differences from baseline with Tiotropium/olodaterol versus Tiotropium were + 0.074 l (95% confidence interval [CI] 0.033, 0.115; P  = 0.0004) for trough FEV_1, − 2.675 (95% CI − 5.060, − 0.291; P  = 0.0280) for SGRQ and 1.148 (95% CI 0.564, 1.732; P  = 0.0001) for TDI. Patients were more likely to respond when treated with Tiotropium/olodaterol versus Tiotropium for trough FEV_1 (odds ratio [OR] 3.14, 95% CI 1.94, 5.06; P  

  • Efficacy of Tiotropium/Olodaterol Compared with Tiotropium as a First-Line Maintenance Treatment in Patients with COPD Who Are Naïve to LAMA, LABA and ICS: Pooled Analysis of Four Clinical Trials
    Advances in Therapy, 2020
    Co-Authors: Roland Buhl, Dave Singh, Gary T Ferguson
    Abstract:

    People with chronic obstructive pulmonary disease (COPD) often have problems breathing, which can make it difficult to carry out daily physical tasks. Bronchodilators are a type of medication that relax the muscles in the lungs and widen airways, making it easier to breathe. Evidence suggests that using a combination of two different bronchodilators is more effective than using one bronchodilator on its own. In this article, we look at four large studies that compared the effects of at least 12 weeks of treatment with two bronchodilators (Tiotropium/olodaterol) with Tiotropium on its own in people who had not received any previous medication for their COPD. The results suggest that people who were treated with Tiotropium and olodaterol together had significantly better improvements in lung function, quality of life and breathlessness after 12 weeks than those taking Tiotropium alone, without compromising safety. Overall, people treated with Tiotropium/olodaterol were 60% more likely to experience a meaningful improvement in at least one of these areas compared with those on Tiotropium alone. These results support the use of Tiotropium and olodaterol together as a first medication for COPD. Introduction The efficacy of Tiotropium/olodaterol compared with Tiotropium in patients with chronic obstructive pulmonary disease (COPD) has been demonstrated in a large clinical programme. Currently, randomised controlled trial (RCT) data on dual bronchodilation as first-line maintenance therapy are limited. In this post hoc analysis of pooled data from four RCTs, we compared the efficacy of Tiotropium/olodaterol versus Tiotropium as maintenance therapy in patients with COPD who were not receiving maintenance treatment with long-acting muscarinic antagonists (LAMAs), long-acting β_2-agonists (LABAs) or inhaled corticosteroids (ICS) (“maintenance naïve”) at study entry. Methods TONADO^® 1/2 (52 weeks) and OTEMTO^® 1/2 (12 weeks) were phase III RCTs in patients with COPD. TONADO 1/2 and OTEMTO 1/2 enrolled patients with post-bronchodilator forced expiratory volume in 1 s (FEV_1) 

  • benefits of Tiotropium olodaterol compared with Tiotropium in patients with copd receiving only lama at baseline pooled analysis of the tonado and otemto studies
    Advances in Therapy, 2020
    Co-Authors: Roland Buhl, Dave Singh, Gary T Ferguson
    Abstract:

    INTRODUCTION The Global Initiative for Chronic Obstructive Lung Disease (GOLD) strategy report recommends long-acting muscarinic antagonists (LAMA) or long-acting β2-agonists (LABA) as first-line treatment for chronic obstructive pulmonary disease (COPD), but many patients remain symptomatic on monotherapy and escalation to dual-bronchodilator therapy may be warranted. METHODS TONADO® 1&2 and OTEMTO® 1&2 assessed lung function and patient-reported outcomes in patients with moderate-to-severe (OTEMTO) or moderate-to-very-severe (TONADO) COPD. This pooled post hoc analysis included patients treated with LAMA monotherapy at baseline who were randomised to receive either 5 µg Tiotropium (LAMA) or 5/5 µg Tiotropium/olodaterol (LAMA/LABA). We assessed changes from baseline and responder rates for trough forced expiratory volume in 1 s (FEV1), St. George's Respiratory Questionnaire (SGRQ) and the Transition Dyspnoea Index (TDI). RESULTS Overall, 151 patients received Tiotropium; 148 received Tiotropium/olodaterol. Mean differences from baseline with Tiotropium/olodaterol versus Tiotropium were + 0.074 l (95% confidence interval [CI] 0.033, 0.115; P = 0.0004) for trough FEV1, - 2.675 (95% CI - 5.060, - 0.291; P = 0.0280) for SGRQ and 1.148 (95% CI 0.564, 1.732; P = 0.0001) for TDI. Patients were more likely to respond when treated with Tiotropium/olodaterol versus Tiotropium for trough FEV1 (odds ratio [OR] 3.14, 95% CI 1.94, 5.06; P < 0.0001), SGRQ (OR 1.49, 95% CI 0.93, 2.40; P = 0.0980) and TDI (OR 2.81, 95% CI 1.71, 4.60; P < 0.0001). Minimum clinically important difference from baseline in any of the analysed outcomes (FEV1 ≥ 0.1 l, SGRQ ≥ 4.0 points or TDI ≥ 1.0 point) was more likely in patients treated with Tiotropium/olodaterol versus Tiotropium (OR 2.43, 95% CI 1.32, 4.51; P = 0.0046). CONCLUSION In patients with COPD receiving only LAMA monotherapy, treatment escalation to Tiotropium/olodaterol resulted in statistically significant and clinically relevant improvements in lung function, health status and breathlessness. These results support early therapy optimisation to dual bronchodilation with Tiotropium/olodaterol in patients receiving Tiotropium alone. TRIAL REGISTRATION TONADO® 1 was registered in the US National Library of Medicine on 9 September 2011 (Clinicaltrials.gov: NCT01431274). TONADO® 2 was registered in the US National Library of Medicine on 9 September 2011 (Clinicaltrials.gov: NCT01431287). OTEMTO® 1 was registered in the US National Library of Medicine on 17 October 2013 (Clinicaltrials.gov: NCT01964352). OTEMTO® 2 was registered in the US National Library of Medicine on 10 December 2013 (Clinicaltrials.gov: NCT02006732).

  • Benefits of Tiotropium/Olodaterol Compared with Tiotropium in Patients with COPD Receiving only LAMA at Baseline: Pooled Analysis of the TONADO® and OTEMTO® Studies.
    Advances in therapy, 2020
    Co-Authors: Roland Buhl, Dave Singh, Gary T Ferguson
    Abstract:

    The Global Initiative for Chronic Obstructive Lung Disease (GOLD) strategy report recommends long-acting muscarinic antagonists (LAMA) or long-acting β2-agonists (LABA) as first-line treatment for chronic obstructive pulmonary disease (COPD), but many patients remain symptomatic on monotherapy and escalation to dual-bronchodilator therapy may be warranted. TONADO® 1&2 and OTEMTO® 1&2 assessed lung function and patient-reported outcomes in patients with moderate-to-severe (OTEMTO) or moderate-to-very-severe (TONADO) COPD. This pooled post hoc analysis included patients treated with LAMA monotherapy at baseline who were randomised to receive either 5 µg Tiotropium (LAMA) or 5/5 µg Tiotropium/olodaterol (LAMA/LABA). We assessed changes from baseline and responder rates for trough forced expiratory volume in 1 s (FEV1), St. George's Respiratory Questionnaire (SGRQ) and the Transition Dyspnoea Index (TDI). Overall, 151 patients received Tiotropium; 148 received Tiotropium/olodaterol. Mean differences from baseline with Tiotropium/olodaterol versus Tiotropium were + 0.074 l (95% confidence interval [CI] 0.033, 0.115; P = 0.0004) for trough FEV1, - 2.675 (95% CI - 5.060, - 0.291; P = 0.0280) for SGRQ and 1.148 (95% CI 0.564, 1.732; P = 0.0001) for TDI. Patients were more likely to respond when treated with Tiotropium/olodaterol versus Tiotropium for trough FEV1 (odds ratio [OR] 3.14, 95% CI 1.94, 5.06; P < 0.0001), SGRQ (OR 1.49, 95% CI 0.93, 2.40; P = 0.0980) and TDI (OR 2.81, 95% CI 1.71, 4.60; P < 0.0001). Minimum clinically important difference from baseline in any of the analysed outcomes (FEV1 ≥ 0.1 l, SGRQ ≥ 4.0 points or TDI ≥ 1.0 point) was more likely in patients treated with Tiotropium/olodaterol versus Tiotropium (OR 2.43, 95% CI 1.32, 4.51; P = 0.0046). In patients with COPD receiving only LAMA monotherapy, treatment escalation to Tiotropium/olodaterol resulted in statistically significant and clinically relevant improvements in lung function, health status and breathlessness. These results support early therapy optimisation to dual bronchodilation with Tiotropium/olodaterol in patients receiving Tiotropium alone. TONADO® 1 was registered in the US National Library of Medicine on 9 September 2011 (Clinicaltrials.gov: NCT01431274). TONADO® 2 was registered in the US National Library of Medicine on 9 September 2011 (Clinicaltrials.gov: NCT01431287). OTEMTO® 1 was registered in the US National Library of Medicine on 17 October 2013 (Clinicaltrials.gov: NCT01964352). OTEMTO® 2 was registered in the US National Library of Medicine on 10 December 2013 (Clinicaltrials.gov: NCT02006732).

  • safety of Tiotropium olodaterol in chronic obstructive pulmonary disease pooled analysis of three large 52 week randomized clinical trials
    Respiratory Medicine, 2018
    Co-Authors: Gary T Ferguson, Roland Buhl, Antonio Anzueto, Ulrich Bothner, Peter M A Calverley
    Abstract:

    Abstract Background An extensive clinical trial program supports the efficacy and safety of Tiotropium/olodaterol in chronic obstructive pulmonary disease (COPD). We examined the safety of Tiotropium/olodaterol compared with Tiotropium in a large population of patients, focusing on cardiovascular and respiratory events. Methods Patients (n = 9942) who received once-daily Tiotropium/olodaterol 5/5 μg or Tiotropium 5 μg (via Respimat®) in TONADO 1 & 2 and DYNAGITO were included. The number of patients and exposure-adjusted rate of events are presented for adverse events (AEs), serious AEs (SAEs), AEs leading to discontinuation, and cardiovascular and respiratory events. Findings Fewer patients discontinued due to AEs with Tiotropium/olodaterol (5.9%) versus Tiotropium (7.9%; rate ratio [RR] 0.72; 95% confidence interval [CI] 0.62–0.84). There was no significant difference in the incidence of AEs, SAEs, cardiovascular AEs or central nervous system vascular AEs between treatments. Incidences of major adverse cardiovascular events (MACE) were 2.11 per 100 patient-years with Tiotropium/olodaterol and 2.22 with Tiotropium (RR 0.95; 95% CI 0.72–1.25), and incidences of fatal MACE (including death with undetermined cause) were 0.91 and 1.00 per 100 patient-years with Tiotropium/olodaterol and Tiotropium, respectively (RR 0.91; 95% CI 0.60–1.37). Respiratory AEs were generally balanced between treatment groups. Conclusions These results provide robust evidence that the benefits of Tiotropium/olodaterol versus Tiotropium are not at the expense of an increased risk of safety events. The combination is a suitable option for patients with COPD, even in the presence of cardiovascular risk factors. Clinical trials registration clinicaltrials. gov (TONADO 1 and 2: NCT01431274, NCT01431287; DYNAGITO: NCT02296138).

Masakazu Ichinose - One of the best experts on this subject based on the ideXlab platform.

  • effect of Tiotropium olodaterol on sedentary and active time in patients with copd post hoc analysis of the vesuto study
    International Journal of Chronic Obstructive Pulmonary Disease, 2019
    Co-Authors: Yoshiaki Minakata, Jun Ueki, Tatsuhiko Anzai, Shuhei Nakamura, Takashi Motegi, Kazuto Hirata, Masakazu Ichinose
    Abstract:

    Background: Patients with COPD are less physically active. This post hoc analysis of a randomized, double-blind, active-controlled, crossover trial assessed the efficacy of once-daily Tiotropium/olodaterol combination therapy versus Tiotropium monotherapy in Japanese patients with COPD. Patients and methods: Patients were provided with a three-axis accelerometer to measure sedentary and active behavior defined as 1.0-1.5 metabolic equivalents (METs), ≥2.0 METs, and ≥3.0 METs, respectively. Of the 182 patients enrolled, 131 satisfied the conditions for the present analysis and were randomized to Tiotropium monotherapy (n=62) or Tiotropium/olodaterol combination therapy (n=69). Results: Tiotropium/olodaterol combination therapy significantly reduced the duration of 1.0-1.5 MET activity by 8.64 mins (p=0.040) and significantly increased the duration of ≥2.0 MET and ≥3.0 MET activity by 6.51 mins (p=0.017) and 2.60 mins (p=0.008), respectively, compared with Tiotropium alone. Subgroup analyses showed that better lung function, milder dyspnea, and higher levels of physical activity at baseline were associated with reduced sedentary time and increased duration of physical activity. Conclusion: Tiotropium/olodaterol combination therapy significantly reduced sedentary time and improved physical activity compared with Tiotropium monotherapy. This trial was registered in ClinicalTrials.gov (NCT02629965).

  • Effect of Tiotropium/olodaterol on sedentary and active time in patients with COPD: post hoc analysis of the VESUTO ® study
    International Journal of Chronic Obstructive Pulmonary Disease, 2019
    Co-Authors: Yoshiaki Minakata, Jun Ueki, Tatsuhiko Anzai, Shuhei Nakamura, Takashi Motegi, Kazuto Hirata, Masakazu Ichinose
    Abstract:

    Background: Patients with COPD are less physically active. This post hoc analysis of a randomized, double-blind, active-controlled, crossover trial assessed the efficacy of once-daily Tiotropium/olodaterol combination therapy versus Tiotropium monotherapy in Japanese patients with COPD. Patients and methods: Patients were provided with a three-axis accelerometer to measure sedentary and active behavior defined as 1.0-1.5 metabolic equivalents (METs), ≥2.0 METs, and ≥3.0 METs, respectively. Of the 182 patients enrolled, 131 satisfied the conditions for the present analysis and were randomized to Tiotropium monotherapy (n=62) or Tiotropium/olodaterol combination therapy (n=69). Results: Tiotropium/olodaterol combination therapy significantly reduced the duration of 1.0-1.5 MET activity by 8.64 mins (p=0.040) and significantly increased the duration of ≥2.0 MET and ≥3.0 MET activity by 6.51 mins (p=0.017) and 2.60 mins (p=0.008), respectively, compared with Tiotropium alone. Subgroup analyses showed that better lung function, milder dyspnea, and higher levels of physical activity at baseline were associated with reduced sedentary time and increased duration of physical activity. Conclusion: Tiotropium/olodaterol combination therapy significantly reduced sedentary time and improved physical activity compared with Tiotropium monotherapy. This trial was registered in ClinicalTrials.gov (NCT02629965).

  • efficacy of Tiotropium olodaterol on lung volume exercise capacity and physical activity
    International Journal of Chronic Obstructive Pulmonary Disease, 2018
    Co-Authors: Masakazu Ichinose, Yoshiaki Minakata, Jun Ueki, Tetsuo Seki, Tatsuhiko Anzai, Shuhei Nakamura, Takashi Motegi, Kazuto Hirata
    Abstract:

    Purpose: This study evaluated the efficacy of Tiotropium/olodaterol vs Tiotropium on lung function, exercise capacity, and physical activity in patients with COPD. Patients and methods: A total of 184 patients aged ≥40 years with COPD (Global Initiative for Chronic Obstructive Lung Disease stage II-IV) received Tiotropium/olodaterol for 6 weeks, then Tiotropium for 6 weeks, or vice versa. The primary endpoint was inspiratory capacity (IC) at peak post-dose. Results: Adjusted mean IC after 6-week treatment was 1.990 L with Tiotropium/olodaterol vs 1.875 L with Tiotropium (difference: 115 mL; 95% CI: 77, 153; p<0.0001). Forced expiratory volume in 1 s (difference: 105 mL; 95% CI: 88, 123), forced vital capacity (difference: 163 mL; 95% CI: 130, 197), and slow vital capacity (difference: 134 mL; 95% CI: 91, 176) improved with Tiotropium/olodaterol (all p<0.0001). Adjusted mean 6-min walk distance was similar between treatments in the overall population but was significantly increased with Tiotropium/olodaterol in the subgroup with Global Initiative for Chronic Obstructive Lung Disease stage III/IV at baseline (difference: 18.1 m; 95% CI: 2.3, 33.9; p=0.0254). In a post hoc analysis, Tiotropium/olodaterol improved the values for ≥2.0 metabolic equivalents (difference: 5.0 min; 95% CI: 0.4, 9.7; p=0.0337). Conclusion: Tiotropium/olodaterol significantly improved IC compared with Tiotropium and potentially enhanced the exercise capacity in COPD patients. A slight improvement in physical activity of relatively more than moderate intensity was also seen with Tiotropium/olodaterol.

  • Efficacy of Tiotropium/olodaterol on lung volume, exercise capacity, and physical activity
    International Journal of Chronic Obstructive Pulmonary Disease, 2018
    Co-Authors: Masakazu Ichinose, Yoshiaki Minakata, Jun Ueki, Tetsuo Seki, Tatsuhiko Anzai, Shuhei Nakamura, Takashi Motegi, Kazuto Hirata
    Abstract:

    Purpose: This study evaluated the efficacy of Tiotropium/olodaterol vs Tiotropium on lung function, exercise capacity, and physical activity in patients with COPD. Patients and methods: A total of 184 patients aged ≥40 years with COPD (Global Initiative for Chronic Obstructive Lung Disease stage II-IV) received Tiotropium/olodaterol for 6 weeks, then Tiotropium for 6 weeks, or vice versa. The primary endpoint was inspiratory capacity (IC) at peak post-dose. Results: Adjusted mean IC after 6-week treatment was 1.990 L with Tiotropium/olodaterol vs 1.875 L with Tiotropium (difference: 115 mL; 95% CI: 77, 153; p

  • lung function and long term safety of Tiotropium olodaterol in east asian patients with chronic obstructive pulmonary disease
    International Journal of Chronic Obstructive Pulmonary Disease, 2017
    Co-Authors: Masakazu Ichinose, Olaf Jons, Yihua Zhao, Ulrich Bothner, Roland Buhl
    Abstract:

    Background and purpose: While the efficacy and safety of combined Tiotropium and olodaterol in patients with COPD was established in a large clinical trial program, it is important to assess whether clinical data can be applied to geographic patient groups, particularly for East Asian patients who may have a different phenotypic profile to the global trial population. This study aimed to compare the lung function and safety profiles of Tiotropium/olodaterol and monocomponents in East Asian and global populations from the TONADO® trials. Materials and methods: In the replicate, double-blind, parallel-group, active-controlled, randomized, 52-week, Phase III TONADO studies, patients received Tiotropium/olodaterol, Tiotropium, or olodaterol. We assessed the forced expiratory volume in 1 second (FEV1) area under the curve from 0 to 3 hours (AUC0-3) response and trough FEV1 response at 24 weeks for the approved doses, Tiotropium/olodaterol 5/5 μg, Tiotropium 5 μg, and olodaterol 5 μg. Treatment-emergent adverse events were recorded throughout treatment and ≤21 days after study medication. Results: In the East Asian population, 1,152 patients were randomized (5,163 overall). After 24 weeks, FEV1 AUC0-3 and trough FEV1 responses were greater (P<0.0001) with Tiotropium/olodaterol 5/5 μg in both populations versus Tiotropium or olodaterol. The East Asian population showed slightly greater trough FEV1 treatment differences between Tiotropium/olodaterol 5/5 μg and Tiotropium compared to the overall population. Generally, no increase in adverse events was seen with Tiotropium/olodaterol 5/5 μg compared to Tiotropium and olodaterol in either population. Conclusion: The efficacy and safety profile of Tiotropium/olodaterol 5/5 μg has been demonstrated for both East Asian and global populations.

Antonio Anzueto - One of the best experts on this subject based on the ideXlab platform.

  • Tiotropium/Olodaterol Decreases Exacerbation Rates Compared with Tiotropium in a Range of Patients with COPD: Pooled Analysis of the TONADO®/DYNAGITO® Trials.
    Advances in therapy, 2020
    Co-Authors: Jadwiga A Wedzicha, Roland Buhl, Antonio Anzueto, Dave Singh, Claus F Vogelmeier, Peter M A Calverley
    Abstract:

    Previous studies demonstrated that Tiotropium/olodaterol reduced rates of exacerbations in patients with chronic obstructive pulmonary disease (COPD). However, this should be examined in a wider population. This post hoc analysis pooled data from TONADO® 1 + 2 and DYNAGITO®, three 52-week, parallel-group, randomised, double-blind, phase III trials investigating patients with moderate-to-very severe COPD, with and without previous exacerbations, who received Tiotropium/olodaterol 5/5 µg or Tiotropium 5 µg. Subgroup analyses were conducted on patients stratified by exacerbation history, Global Initiative for Chronic Obstructive Lung Disease (GOLD) stage 2-4 disease severity and baseline inhaled corticosteroid (ICS) use. In 9942 patients, Tiotropium/olodaterol was associated with lower rates of moderate/severe exacerbations (0.68 vs. 0.77 per patient-year; rate ratio (RR) vs. Tiotropium 0.89, 95% confidence interval (CI) 0.84, 0.95; P = 0.0003) and exacerbations requiring hospitalisation (0.11 vs. 0.13 per patient-year; RR 0.86, 95% CI 0.75, 0.99; P = 0.0380) versus Tiotropium. Lower rates of moderate/severe exacerbations with Tiotropium/olodaterol versus Tiotropium were evident in patients with 0-1 moderate exacerbation in the previous year (0.54 vs. 0.60 per patient-year; RR 0.90, 95% CI 0.82, 0.98; P = 0.0187) and at least two moderate or at least one severe exacerbation(s) in the previous year (0.97 vs. 1.09 per patient-year; RR 0.89, 95% CI 0.82, 0.97; P = 0.0096). In patients with GOLD 2 and GOLD 3 COPD, moderate/severe exacerbation rates were lower with Tiotropium/olodaterol versus Tiotropium; GOLD 4 patients showed negligible difference between treatments. When evaluating patients by baseline ICS use, there was a significantly lower rate of moderate/severe exacerbations with Tiotropium/olodaterol versus Tiotropium in patients receiving ICS. Tiotropium/olodaterol decreased the rate of moderate/severe exacerbations and exacerbations leading to hospitalisation versus Tiotropium. Results from this large, pooled, post hoc analysis support the use of dual bronchodilation with Tiotropium/olodaterol in a broad range of patients, reflective of patients with COPD in clinical practice. TONADO® 1 (ClinicalTrials.gov: NCT01431274); TONADO® 2 (ClinicalTrials.gov: NCT01431287); DYNAGITO® (ClinicalTrials.gov: NCT02296138). People with chronic obstructive pulmonary disease (COPD) may have times when their symptoms worsen, known as exacerbations. This may mean that they need to take additional medications, such as antibiotics or oral steroids. Studies have shown that a combination of two types of inhaled medicine-Tiotropium and olodaterol-can help to reduce exacerbations in some people. To see if this is also the case across a larger and more diverse range of people, we combined the results from three studies (TONADO® 1 + 2 and DYNAGITO®) that looked at people who were taking Tiotropium and olodaterol together and people who were taking Tiotropium alone. We showed that, across a wide range of people, treatment with Tiotropium/olodaterol was generally better at reducing exacerbations than Tiotropium. Tiotropium/olodaterol also decreased the number of exacerbations that led to hospitalisation compared with Tiotropium. Overall, our results support the use of combined Tiotropium/olodaterol in people at different stages of COPD.

  • Tiotropium/Olodaterol Decreases Exacerbation Rates Compared with Tiotropium in a Range of Patients with COPD: Pooled Analysis of the TONADO^®/DYNAGITO^® Trials
    Advances in Therapy, 2020
    Co-Authors: Jadwiga A Wedzicha, Roland Buhl, Antonio Anzueto, Dave Singh, Claus F Vogelmeier, Peter M A Calverley
    Abstract:

    Introduction Previous studies demonstrated that Tiotropium/olodaterol reduced rates of exacerbations in patients with chronic obstructive pulmonary disease (COPD). However, this should be examined in a wider population. Methods This post hoc analysis pooled data from TONADO^® 1 + 2 and DYNAGITO^®, three 52-week, parallel-group, randomised, double-blind, phase III trials investigating patients with moderate-to-very severe COPD, with and without previous exacerbations, who received Tiotropium/olodaterol 5/5 µg or Tiotropium 5 µg. Subgroup analyses were conducted on patients stratified by exacerbation history, Global Initiative for Chronic Obstructive Lung Disease (GOLD) stage 2–4 disease severity and baseline inhaled corticosteroid (ICS) use. Results In 9942 patients, Tiotropium/olodaterol was associated with lower rates of moderate/severe exacerbations (0.68 vs. 0.77 per patient-year; rate ratio (RR) vs. Tiotropium 0.89, 95% confidence interval (CI) 0.84, 0.95; P  = 0.0003) and exacerbations requiring hospitalisation (0.11 vs. 0.13 per patient-year; RR 0.86, 95% CI 0.75, 0.99; P  = 0.0380) versus Tiotropium. Lower rates of moderate/severe exacerbations with Tiotropium/olodaterol versus Tiotropium were evident in patients with 0–1 moderate exacerbation in the previous year (0.54 vs. 0.60 per patient-year; RR 0.90, 95% CI 0.82, 0.98; P  = 0.0187) and at least two moderate or at least one severe exacerbation(s) in the previous year (0.97 vs. 1.09 per patient-year; RR 0.89, 95% CI 0.82, 0.97; P  = 0.0096). In patients with GOLD 2 and GOLD 3 COPD, moderate/severe exacerbation rates were lower with Tiotropium/olodaterol versus Tiotropium; GOLD 4 patients showed negligible difference between treatments. When evaluating patients by baseline ICS use, there was a significantly lower rate of moderate/severe exacerbations with Tiotropium/olodaterol versus Tiotropium in patients receiving ICS. Conclusions Tiotropium/olodaterol decreased the rate of moderate/severe exacerbations and exacerbations leading to hospitalisation versus Tiotropium. Results from this large, pooled, post hoc analysis support the use of dual bronchodilation with Tiotropium/olodaterol in a broad range of patients, reflective of patients with COPD in clinical practice. Trial Registration TONADO^® 1 (ClinicalTrials.gov: NCT01431274); TONADO^® 2 (ClinicalTrials.gov: NCT01431287); DYNAGITO^® (ClinicalTrials.gov: NCT02296138). Plain Language Summary People with chronic obstructive pulmonary disease (COPD) may have times when their symptoms worsen, known as exacerbations. This may mean that they need to take additional medications, such as antibiotics or oral steroids. Studies have shown that a combination of two types of inhaled medicine—Tiotropium and olodaterol—can help to reduce exacerbations in some people. To see if this is also the case across a larger and more diverse range of people, we combined the results from three studies (TONADO^® 1 + 2 and DYNAGITO^®) that looked at people who were taking Tiotropium and olodaterol together and people who were taking Tiotropium alone. We showed that, across a wide range of people, treatment with Tiotropium/olodaterol was generally better at reducing exacerbations than Tiotropium. Tiotropium/olodaterol also decreased the number of exacerbations that led to hospitalisation compared with Tiotropium. Overall, our results support the use of combined Tiotropium/olodaterol in people at different stages of COPD. Graphical Abstract

  • Tiotropium olodaterol decreases exacerbation rates compared with Tiotropium in a range of patients with copd pooled analysis of the tonado dynagito trials
    Advances in Therapy, 2020
    Co-Authors: Jadwiga A Wedzicha, Antonio Anzueto, Dave Singh, Claus F Vogelmeier, R Buhl, Peter M A Calverley
    Abstract:

    INTRODUCTION Previous studies demonstrated that Tiotropium/olodaterol reduced rates of exacerbations in patients with chronic obstructive pulmonary disease (COPD). However, this should be examined in a wider population. METHODS This post hoc analysis pooled data from TONADO® 1 + 2 and DYNAGITO®, three 52-week, parallel-group, randomised, double-blind, phase III trials investigating patients with moderate-to-very severe COPD, with and without previous exacerbations, who received Tiotropium/olodaterol 5/5 µg or Tiotropium 5 µg. Subgroup analyses were conducted on patients stratified by exacerbation history, Global Initiative for Chronic Obstructive Lung Disease (GOLD) stage 2-4 disease severity and baseline inhaled corticosteroid (ICS) use. RESULTS In 9942 patients, Tiotropium/olodaterol was associated with lower rates of moderate/severe exacerbations (0.68 vs. 0.77 per patient-year; rate ratio (RR) vs. Tiotropium 0.89, 95% confidence interval (CI) 0.84, 0.95; P = 0.0003) and exacerbations requiring hospitalisation (0.11 vs. 0.13 per patient-year; RR 0.86, 95% CI 0.75, 0.99; P = 0.0380) versus Tiotropium. Lower rates of moderate/severe exacerbations with Tiotropium/olodaterol versus Tiotropium were evident in patients with 0-1 moderate exacerbation in the previous year (0.54 vs. 0.60 per patient-year; RR 0.90, 95% CI 0.82, 0.98; P = 0.0187) and at least two moderate or at least one severe exacerbation(s) in the previous year (0.97 vs. 1.09 per patient-year; RR 0.89, 95% CI 0.82, 0.97; P = 0.0096). In patients with GOLD 2 and GOLD 3 COPD, moderate/severe exacerbation rates were lower with Tiotropium/olodaterol versus Tiotropium; GOLD 4 patients showed negligible difference between treatments. When evaluating patients by baseline ICS use, there was a significantly lower rate of moderate/severe exacerbations with Tiotropium/olodaterol versus Tiotropium in patients receiving ICS. CONCLUSIONS Tiotropium/olodaterol decreased the rate of moderate/severe exacerbations and exacerbations leading to hospitalisation versus Tiotropium. Results from this large, pooled, post hoc analysis support the use of dual bronchodilation with Tiotropium/olodaterol in a broad range of patients, reflective of patients with COPD in clinical practice. TRIAL REGISTRATION TONADO® 1 (ClinicalTrials.gov: NCT01431274); TONADO® 2 (ClinicalTrials.gov: NCT01431287); DYNAGITO® (ClinicalTrials.gov: NCT02296138). People with chronic obstructive pulmonary disease (COPD) may have times when their symptoms worsen, known as exacerbations. This may mean that they need to take additional medications, such as antibiotics or oral steroids. Studies have shown that a combination of two types of inhaled medicine-Tiotropium and olodaterol-can help to reduce exacerbations in some people. To see if this is also the case across a larger and more diverse range of people, we combined the results from three studies (TONADO® 1 + 2 and DYNAGITO®) that looked at people who were taking Tiotropium and olodaterol together and people who were taking Tiotropium alone. We showed that, across a wide range of people, treatment with Tiotropium/olodaterol was generally better at reducing exacerbations than Tiotropium. Tiotropium/olodaterol also decreased the number of exacerbations that led to hospitalisation compared with Tiotropium. Overall, our results support the use of combined Tiotropium/olodaterol in people at different stages of COPD.

  • safety of Tiotropium olodaterol in chronic obstructive pulmonary disease pooled analysis of three large 52 week randomized clinical trials
    Respiratory Medicine, 2018
    Co-Authors: Gary T Ferguson, Roland Buhl, Antonio Anzueto, Ulrich Bothner, Peter M A Calverley
    Abstract:

    Abstract Background An extensive clinical trial program supports the efficacy and safety of Tiotropium/olodaterol in chronic obstructive pulmonary disease (COPD). We examined the safety of Tiotropium/olodaterol compared with Tiotropium in a large population of patients, focusing on cardiovascular and respiratory events. Methods Patients (n = 9942) who received once-daily Tiotropium/olodaterol 5/5 μg or Tiotropium 5 μg (via Respimat®) in TONADO 1 & 2 and DYNAGITO were included. The number of patients and exposure-adjusted rate of events are presented for adverse events (AEs), serious AEs (SAEs), AEs leading to discontinuation, and cardiovascular and respiratory events. Findings Fewer patients discontinued due to AEs with Tiotropium/olodaterol (5.9%) versus Tiotropium (7.9%; rate ratio [RR] 0.72; 95% confidence interval [CI] 0.62–0.84). There was no significant difference in the incidence of AEs, SAEs, cardiovascular AEs or central nervous system vascular AEs between treatments. Incidences of major adverse cardiovascular events (MACE) were 2.11 per 100 patient-years with Tiotropium/olodaterol and 2.22 with Tiotropium (RR 0.95; 95% CI 0.72–1.25), and incidences of fatal MACE (including death with undetermined cause) were 0.91 and 1.00 per 100 patient-years with Tiotropium/olodaterol and Tiotropium, respectively (RR 0.91; 95% CI 0.60–1.37). Respiratory AEs were generally balanced between treatment groups. Conclusions These results provide robust evidence that the benefits of Tiotropium/olodaterol versus Tiotropium are not at the expense of an increased risk of safety events. The combination is a suitable option for patients with COPD, even in the presence of cardiovascular risk factors. Clinical trials registration clinicaltrials. gov (TONADO 1 and 2: NCT01431274, NCT01431287; DYNAGITO: NCT02296138).

  • Safety of Tiotropium/olodaterol in chronic obstructive pulmonary disease: pooled analysis of three large, 52-week, randomized clinical trials.
    Respiratory Medicine, 2018
    Co-Authors: Gary T Ferguson, Roland Buhl, Antonio Anzueto, Florian Voß, Ulrich Bothner, Peter M A Calverley
    Abstract:

    Abstract Background An extensive clinical trial program supports the efficacy and safety of Tiotropium/olodaterol in chronic obstructive pulmonary disease (COPD). We examined the safety of Tiotropium/olodaterol compared with Tiotropium in a large population of patients, focusing on cardiovascular and respiratory events. Methods Patients (n = 9942) who received once-daily Tiotropium/olodaterol 5/5 μg or Tiotropium 5 μg (via Respimat®) in TONADO 1 & 2 and DYNAGITO were included. The number of patients and exposure-adjusted rate of events are presented for adverse events (AEs), serious AEs (SAEs), AEs leading to discontinuation, and cardiovascular and respiratory events. Findings Fewer patients discontinued due to AEs with Tiotropium/olodaterol (5.9%) versus Tiotropium (7.9%; rate ratio [RR] 0.72; 95% confidence interval [CI] 0.62–0.84). There was no significant difference in the incidence of AEs, SAEs, cardiovascular AEs or central nervous system vascular AEs between treatments. Incidences of major adverse cardiovascular events (MACE) were 2.11 per 100 patient-years with Tiotropium/olodaterol and 2.22 with Tiotropium (RR 0.95; 95% CI 0.72–1.25), and incidences of fatal MACE (including death with undetermined cause) were 0.91 and 1.00 per 100 patient-years with Tiotropium/olodaterol and Tiotropium, respectively (RR 0.91; 95% CI 0.60–1.37). Respiratory AEs were generally balanced between treatment groups. Conclusions These results provide robust evidence that the benefits of Tiotropium/olodaterol versus Tiotropium are not at the expense of an increased risk of safety events. The combination is a suitable option for patients with COPD, even in the presence of cardiovascular risk factors. Clinical trials registration clinicaltrials. gov (TONADO 1 and 2: NCT01431274, NCT01431287; DYNAGITO: NCT02296138).

Related terms

Tiotropium - 15 days free trial to Access Experts & Abstracts