Tiotropium and olodaterol in the prevention of chronic obstructive pulmonary disease exacerbations (DYNAGITO): a double-blind, randomised, parallel-group, active-controlled trial

Calverley, Peter M.A.; Anzueto, Antonio; Carter, Kerstine; Grönke, L; Hallmann, Christoph; Jenkins, Christine; Wedzicha, Jadwiga A.; Rabe, Klaus F.

doi:10.1016/s2213-2600(18)30102-4

Cited by 158 publications

(180 citation statements)

References 29 publications

Supporting

Mentioning

155

Contrasting

Unclassified

Order By: Relevance

“…Dyspnea score: assessed using the Transition Dyspnea Index or COPD Assessment Test. Eleven studies (n = 17,650) assessed dyspnea (5,6,10,15,17,19,20,22,(25)(26)(27). Because the Transition Dyspnea Index (TDI) and the COPD Assessment Test (CAT) are scored in opposite directions, changes in CAT values were multiplied by 21.…”

Section: American Thoracic Society Documentsmentioning

confidence: 99%

Pharmacologic Management of Chronic Obstructive Pulmonary Disease. An Official American Thoracic Society Clinical Practice Guideline

Nici

Mammen

Charbek

et al. 2020

Am J Respir Crit Care Med

227

245

View full text Add to dashboard Cite

Background: This document provides clinical recommendations for the pharmacologic treatment of chronic obstructive pulmonary disease (COPD). It represents a collaborative effort on the part of a panel of expert COPD clinicians and researchers along with a team of methodologists under the guidance of the American Thoracic Society. Methods: Comprehensive evidence syntheses were performed on all relevant studies that addressed the clinical questions and critical patient-centered outcomes agreed upon by the panel of experts. The evidence was appraised, rated, and graded, and recommendations were formulated using the Grading of Recommendations, Assessment, Development, and Evaluation approach. Conclusions: The task force made recommendations regarding the pharmacologic treatment of COPD based on currently available evidence. Additional research in populations that are underrepresented in clinical trials is needed, including studies in patients with COPD 80 years of age and older, those with multiple chronic health conditions, and those with a codiagnosis of COPD and asthma.

show abstract

Section: American Thoracic Society Documentsmentioning

confidence: 99%

Pharmacologic Management of Chronic Obstructive Pulmonary Disease. An Official American Thoracic Society Clinical Practice Guideline

Nici

Mammen

Charbek

et al. 2020

Am J Respir Crit Care Med

227

245

View full text Add to dashboard Cite

show abstract

“…Interestingly, some recent trials did not demonstrate statistically significant reductions in moderate or severe COPD exacerbations despite convincing positive effects on other clinically relevant outcomes including symptoms and lung function [7,8]. A trial's ability to demonstrate a statistically significant treatment effect on exacerbations does not only depend on the number of patients recruited and the size of the treatment effect but also on the exacerbation rate.…”

Section: Introductionmentioning

confidence: 99%

Decline of COPD exacerbations in clinical trials over two decades – a systematic review and meta-regression

et al. 2019

View full text Add to dashboard Cite

Background An important goal of chronic obstructive pulmonary disease (COPD) treatment is to reduce the frequency of exacerbations. Some observations suggest a decline in exacerbation rates in clinical trials over time. A more systematic understanding would help to improve the design and interpretation of COPD trials. Methods We performed a systematic review and meta-regression of the placebo groups in published randomized controlled trials reporting exacerbations as an outcome. A Bayesian negative binomial model was developed to accommodate results that are reported in different formats; results are reported with credible intervals (CI) and posterior tail probabilities (p B ). Results Of 1114 studies identified by our search, 55 were ultimately included. Exacerbation rates decreased by 6.7% (95% CI (4.4, 9.0); p B < 0.001) per year, or 50% (95% CI (36, 61)) per decade. Adjusting for available study and baseline characteristics such as forced expiratory volume in 1 s (FEV 1 ) did not alter the observed trend considerably. Two subsets of studies, one using a true placebo group and the other allowing inhaled corticosteroids in the “placebo” group, also yielded consistent results. Conclusions In conclusion, this meta-regression indicates that the rate of COPD exacerbations decreased over the past two decades to a clinically relevant extent independent of important prognostic factors. This suggests that care is needed in the design of new trials or when comparing results from older trials with more recent ones. Also a considerable effect of adjunct therapy on COPD exacerbations can be assumed. Registration PROSPERO 2018 CRD4218118823. Electronic supplementary material The online version of this article (10.1186/s12931-019-1163-2) contains supplementary material, which is available to authorized users.

show abstract

“…Сравнение комбинации ТИО / ОЛО с тиотропием в отношении среднетяжелых / тяжелых обострений ХОБЛ проведено в исследовании DYNAGITO [40], которое подробно рассматривается в следующем разделе данной публикации. В этом исследовании в группе комбинированной терапии число обострений оказалось достоверно ниже, чем в группе тиотропия.…”

Section: комбинации ддахп / ддба по сравнению с тиотропиемunclassified

“…Для ответа на этот вопрос проведено исследование DYNAGITO -52-недельное двойное слепое РКИ в параллельных группах с активным контролем, целью которого явилось изучение влияния комбинации ТИО / ОЛО на среднетяжелые и тяжелые обострения ХОБЛ по сравнению с тиотропием (оба препарата назначались в виде ингалятора Респимат) [40]. Этим исследованием завершилась глобальная программа клинических исследований ТИО / ОЛО под названием TOVITO, включавшая 8 исследований, направленных на изучение различных конечных точек.…”

Section: что добавляет исследование Dynagito в парадигму лечения хобл?unclassified

Possibilities to prevent acute exacerbation of chronic obstructive pulmonary disease using inhalational therapy. A Report of Expert Panel of Russian Respiratory Society

Авдеев¹,

Белевский²,

Айсанов³

et al. 2018

Pulʹmonologiâ (Mosk.)

View full text Add to dashboard Cite

An impact of acute exacerbation of COPD (AECOPD) on the course and the prognosis of chronic obstructive pulmonary disease depends on severity of the exacerbation. Moderate and severe exacerbations are considered as clinically significant events. Clinical studies investigating a role of inhalational therapy for the risk of AECOPD differed significantly in important parameters and the patients involved were not fully described in the real clinical practice. Tiotropium alone did not demonstrate any benefit over other inhalational therapies, such as inhaled corticosteroid/long-acting β2-agonist (ICS/LABA) combinations and long-acting muscarinic antagonist (LAMA)/LABA combinations, for risk reduction of moderate to severe exacerbations. A benefit of tiotropium/olodaterol combination over tiotropium for the reduction of risk of clinically significant exacerbations was first shown in DYNAGITO study; patients’ groups in this study did not differ in a rate and a spectrum of adverse events including cardiovascular events. An efficient bronchodilating therapy should be administered to all patients with COPD as it could improve dyspnea and prevent exacerbations. Further escalation of treatment in patients with frequent exacerbations of COPD should be personalized according to clinical course and causes of AECOPD.

show abstract

Tiotropium and olodaterol in the prevention of chronic obstructive pulmonary disease exacerbations (DYNAGITO): a double-blind, randomised, parallel-group, active-controlled trial

Abstract: Boehringer Ingelheim International GmbH.

Cited by 158 publications

References 29 publications

Pharmacologic Management of Chronic Obstructive Pulmonary Disease. An Official American Thoracic Society Clinical Practice Guideline

Pharmacologic Management of Chronic Obstructive Pulmonary Disease. An Official American Thoracic Society Clinical Practice Guideline

Decline of COPD exacerbations in clinical trials over two decades – a systematic review and meta-regression

Possibilities to prevent acute exacerbation of chronic obstructive pulmonary disease using inhalational therapy. A Report of Expert Panel of Russian Respiratory Society

Contact Info

Product

Resources

About