Tiotropium/Olodaterol Delays Clinically Important Deterioration Compared with Tiotropium Monotherapy in Patients with Early COPD: a Post Hoc Analysis of the TONADO® Trials

Rabe, Klaus F.; Chalmers, James D.; Miravitlles, Marc; Kocks, Janwillem; Tsiligianni, Ioanna; Hoz, Alberto de la; Xue, Wen‐Qiong; Singh, Dave; Ferguson, Gary T.; Wedzicha, Jadwiga A.

doi:10.1007/s12325-020-01528-2

Cited by 12 publications

(11 citation statements)

References 31 publications

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“…30 Several other studies have also shown the benefits of tiotropium/olodaterol, as well as alternative LAMA/ LABA combinations, including umeclidinium/vilanterol and indacaterol/glycopyrronium, compared with LAMA monotherapy in maintenance-naïve patients. 17,[31][32][33][34] Together, these results suggest that earlier introduction of dual therapy than currently recommended in the GOLD strategy report may be beneficial. For example, there is a strong recommendation in the American Thoracic Society guidelines for dual bronchodilation over monotherapy in patients with COPD and dyspnea or exercise intolerance.…”

mentioning

confidence: 79%

“…[13][14][15][16] Tiotropium/olodaterol was also shown to significantly reduce the risk of clinically important deterioration (as measured by a composite endpoint) in patients with COPD compared with tiotropium alone. 17 However, data from various types of study, including real-world studies, are needed to fully evaluate the impact of pharmacotherapy on clinical control in COPD. 18 Clinical control of COPD can be measured in clinical practice using patient-reported outcomes questionnaires such as the COPD Assessment Test (CAT) or Clinical COPD Questionnaire (CCQ), whereas its stability can be measured based on the presence or absence of exacerbations over time.…”

Section: Introductionmentioning

confidence: 99%

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Therapeutic Success of Tiotropium/Olodaterol, Measured Using the Clinical COPD Questionnaire (CCQ), in Routine Clinical Practice: A Multinational Non-Interventional Study

Valipour¹,

Avdeev²,

Barczyk³

et al. 2021

COPD

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Background The Clinical COPD Questionnaire (CCQ) is a simple patient-reported tool to measure clinical control of chronic obstructive pulmonary disease (COPD). Objective This open-label, single-arm, non-interventional study (NCT03663569) investigated changes in CCQ score during treatment with tiotropium/olodaterol in clinical practice. Methods Data were included from consenting COPD patients, enrolled in Bulgaria, Czech Republic, Hungary, Israel, Lithuania, Poland, Romania, Russia, Slovenia, Switzerland and Ukraine, who were receiving a new prescription for tiotropium/olodaterol according to the treating physician in a real-world environment. The primary endpoint was the occurrence of therapeutic success, defined as a 0.4-point decrease in CCQ score after treatment with tiotropium/olodaterol for approximately 6 weeks. Results Overall, 4819 patients were treated; baseline and Week 6 CCQ scores were available for 4700 patients, mostly classified as Global Initiative for Chronic Obstructive Lung Disease (GOLD) B (51.6%) or D (42.7%). After 6 weeks’ treatment, 81.4% (95% confidence interval [95% CI] 80.24–82.49) of patients achieved therapeutic success; mean improvement in overall CCQ score was 1.02 points (95% CI 1.00–1.05). Improved CCQ score was seen in 92.2% of patients (95% CI 91.43–92.98), 2.5% had no change and 5.3% showed a worsening. When stratified by prior treatment, the greatest benefit was seen in treatment-naïve patients, with 85.7% achieving therapeutic success, compared with 79.5% of those pretreated with long-acting β 2 -agonist (LABA)/inhaled corticosteroid (ICS) and 74.2% of those pretreated with LABA or long-acting muscarinic antagonist (LAMA) monotherapy. Overall, rescue medication decreased by 1.25 puffs/day (95% CI 1.19–1.31) versus baseline. In total, 29 patients (0.6%) reported drug-related adverse events and 7 patients reported serious adverse events (0.15%). Conclusion In 4700 COPD patients, 6 weeks’ treatment with tiotropium/olodaterol, as initial treatment or follow-up to LAMA or LABA monotherapy or LABA/ICS, improved CCQ and decreased rescue medication use. The adverse event profile was consistent with the known safety profile of tiotropium/olodaterol.

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confidence: 79%

Section: Introductionmentioning

confidence: 99%

Therapeutic Success of Tiotropium/Olodaterol, Measured Using the Clinical COPD Questionnaire (CCQ), in Routine Clinical Practice: A Multinational Non-Interventional Study

Valipour¹,

Avdeev²,

Barczyk³

et al. 2021

COPD

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“…The FEV 1 and SGRQ thresholds were selected as the accepted minimum clinically important difference (MCID) for these outcomes [4,5]. Several short-term (6-to 12-month) COPD studies have adopted this endpoint as a post hoc measure [6,7], and associations between short-term CID and long-term outcomes have also been reported [8]. However, most of the participants in those studies were from Western countries, and it is still unclear whether this definition of CID is useful in diverse COPD populations.…”

Section: Introductionmentioning

confidence: 99%

One‐year clinically important deterioration and long‐term clinical course in Japanese patients with COPD: a multicenter observational cohort study

et al. 2021

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Background Chronic obstructive pulmonary disease (COPD) is a heterogeneous disease with a complex progression of many clinical presentations, and clinically important deterioration (CID) has been proposed in the Western studies as a composite endpoint of disease progression. The aim of this study was to investigate the relationships between 1-year CID and the following long-term clinical outcomes in Japanese patients with COPD who have been reported to have different characteristics compared to the Westerners. Methods Among Japanese patients with COPD enrolled in the Hokkaido COPD cohort study, 259 patients who did not drop out within the first year were analyzed in this study. Two definitions of CID were used. Definition 1 comprised ≥ 100 mL decrease in forced expiratory volume in 1 s (FEV1), ≥ 4-unit increase in St George’s Respiratory Questionnaire (SGRQ) score from baseline, or moderate or severe exacerbation. For Definition 2, the thresholds for the FEV1 and SGRQ score components were doubled. The presence of CID was evaluated within the first year from enrollment, and analyzed the association of the presence of CID with following 4-year risk of exacerbations and 9-year mortality. Results Patients with CID using Definition 1, but not any single CID component, during the first year had a significantly worse mortality compared with those without CID. Patients with CID using Definition 2 showed a similar trend on mortality, and had a shorter exacerbation-free survival compared with those without CID. Conclusions Adoption of CID is a beneficial and useful way for the assessment of long-term disease progression and clinical outcomes even in Japanese population with COPD. The definition of CID might be optimized according to the characteristics of COPD population and the observation period for CID.

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“…[4][5][6] The dual bronchodilator combination of a long-acting muscarinic antagonist (LAMA) and a long-acting beta 2 agonist (LABA) reportedly provides greater improvement in pulmonary function and QOL compared with LAMA monotherapy. 7,8 Physical activity is defined as any bodily movement produced by skeletal muscles that leads to energy expenditure. 9 Physical activity includes all activities in daily life, such as indoor activities, walking, and exercise.…”

Section: Introductionmentioning

confidence: 99%

Factors Associated with Reduction of Sedentary Time Following Tiotropium/Olodaterol Therapy in Treatment-Naïve Chronic Obstructive Pulmonary Disease

Takahashi¹,

Tashiro²,

Tajiri³

et al. 2021

COPD

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Background: Prolonged sedentary behavior is associated with worse prognosis in patients with chronic obstructive pulmonary disease (COPD). Our previous study found that first-line dual therapy with tiotropium/olodaterol significantly reduces sedentary time compared to tiotropium monotherapy in Japanese patients with treatment-naïve COPD, although the characteristics of responders to dual-therapy versus monotherapy for COPD are still unclear. Methods: Patients with treatment-naïve COPD were randomized to receive either tiotropium or tiotropium/olodaterol treatment for 12 weeks. Physical activity was assessed using a triaxle accelerometer for 2 weeks before and after treatment. This analysis focused on the change in sedentary time, indicated by physical activity of 1.0-1.5 metabolic equivalents (METs), with stratification for the following factors: age, body mass index (BMI), pulmonary function, COPD assessment test (CAT), the 6-minute walk distance (6MWD), and physical activity level at study entry. Results: Thirty-five patients received tiotropium/olodaterol and 34 patients received tiotropium. In patients with lower inspiratory capacity at study entry, a significant reduction in sedentary time was observed in the tiotropium/olodaterol group compared with the tiotropium group (Tio: −12.8 ± 13.5 min, Tio/Olo: −65.1 ± 21.0 min, mean difference, −52.2 min, 95% CI −103.6 to 0.88, p = 0.046). In patients with a shorter duration of physical activity of ≥2 METs at study entry, a significant reduction of sedentary time was observed in the tiotropium/olodaterol group compared with the tiotropium group (Tio: −3.3 ± 17.5 min, Tio/Olo: −72.9 ± 23.1 min, mean difference, −69.7 min, 95% CI −128.7 to −10.6, p = 0.02). There were no differences in terms of age, BMI, CAT score, 6MWD, FEV1, FVC, VC, and physical activity of 1.0-1.5 METs and ≥3.0 METs. Conclusion:This study showed that COPD patients with lower inspiratory capacity or shorter active time of ≥2.0 METs at study entry are likely to exhibit significantly greater reduction in sedentary time with tiotropium/olodaterol treatment.

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Tiotropium/Olodaterol Delays Clinically Important Deterioration Compared with Tiotropium Monotherapy in Patients with Early COPD: a Post Hoc Analysis of the TONADO® Trials

Cited by 12 publications

References 31 publications

Therapeutic Success of Tiotropium/Olodaterol, Measured Using the Clinical COPD Questionnaire (CCQ), in Routine Clinical Practice: A Multinational Non-Interventional Study

Therapeutic Success of Tiotropium/Olodaterol, Measured Using the Clinical COPD Questionnaire (CCQ), in Routine Clinical Practice: A Multinational Non-Interventional Study

One‐year clinically important deterioration and long‐term clinical course in Japanese patients with COPD: a multicenter observational cohort study

Factors Associated with Reduction of Sedentary Time Following Tiotropium/Olodaterol Therapy in Treatment-Naïve Chronic Obstructive Pulmonary Disease

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