Abstract
BackgroundEscalation to triple therapy (long-acting muscarinic antagonist/β2-agonist, inhaled corticosteroid [ICS]) in chronic obstructive pulmonary disorder (COPD) is recommended for patients on LAMA/LABA combinations with frequent exacerbations and severe symptoms. An extended time-to-escalation to triple therapy suggests patients are in a stable condition and is an indicator of treatment effectiveness. No studies in Japanese clinical practice have compared the effectiveness of LAMA/LABA fixed-dose combination therapies with LAMA monotherapy in terms of time-to-escalation to triple therapy. The primary objective of this real-world study in Japan was to compare time-to-escalation to triple therapy among new users of tiotropium/olodaterol or tiotropium monotherapy for COPD without asthma.MethodsIn this active-comparator cohort study, new users of tiotropium/olodaterol (n = 1436) and tiotropium monotherapy (n = 5352) were identified from a large Japanese hospital-based database (Medical Data Vision Co., Ltd., Tokyo; prespecified study period: 1 April 2015 to 31 March 2019); patients in each group were matched 1:1 using high-dimensional propensity scores (hdPS). The primary outcome was time-to-escalation to triple therapy.ResultsFor the prespecified study period in the hdPS-matched cohort, escalation to triple therapy was infrequent among new users of tiotropium/olodaterol (n = 1302, 7 escalation events) and tiotropium monotherapy (n = 1302, 8 escalation events). The difference in time-to-escalation to triple therapy between groups was not statistically significant (median [interquartile range]: 28 days [15.0–139.2] for tiotropium monotherapy vs 193 days [94.5–302.0] for tiotropium/olodaterol; hazard ratio: 0.89; 95% CI: 0.32–2.46). Similar findings (hazard ratio: 0.71; 95% Cl: 0.36–1.40) were observed in a post hoc analysis, which extended the study period by 1 year to 31 March 2020. Risks of first moderate and/or severe COPD exacerbation were lower for tiotropium/olodaterol than tiotropium monotherapy (between-group differences not significant). There were no significant between-group differences for the risks of all-cause inpatient mortality, major adverse cardiovascular events, and first use of home oxygen therapy.ConclusionsICS monotherapy or ICS/LABA added to tiotropium or tiotropium/olodaterol is limited in Japanese clinical settings. The number of escalations to triple therapy was very limited in the dataset and there was insufficient power to detect differences between the treatment groups in the primary hdPS-matched cohort.
Highlights
Escalation to triple therapy in chronic obstructive pulmonary disorder (COPD) is recommended for patients on long-acting muscarinic antagonists (LAMA)/Long-acting β2-agonist (LABA) combinations with frequent exacerbations and severe symptoms
inhaled corticosteroid (ICS) monotherapy or ICS/LABA added to tiotropium or tiotropium/olodaterol is limited in Japanese clinical settings
The benefits of LAMA/LABA fixed-dose combination inhalers for patients with COPD compared with LAMA or LABA monotherapy have been established in multiple clinical trials [7, 8], but limited data are available on the effectiveness of these inhalers in real-world clinical practice, including in Japan [9]
Summary
Escalation to triple therapy (long-acting muscarinic antagonist/β2-agonist, inhaled corticosteroid [ICS]) in chronic obstructive pulmonary disorder (COPD) is recommended for patients on LAMA/LABA combinations with frequent exacerbations and severe symptoms. No studies in Japanese clinical practice have compared the effectiveness of LAMA/LABA fixed-dose combination therapies with LAMA monotherapy in terms of time-to-escalation to triple therapy. The benefits of LAMA/LABA fixed-dose combination inhalers for patients with COPD compared with LAMA or LABA monotherapy have been established in multiple clinical trials [7, 8], but limited data are available on the effectiveness of these inhalers in real-world clinical practice, including in Japan [9]. One real-world pharmacy claims study in the USA suggests that patients with COPD who initiate a combination LAMA/LABA escalate to triple therapy more slowly and have a lower risk of escalation than those who initiate tiotropium monotherapy [9]. No studies have been conducted in Japanese clinical practice to compare the effectiveness of tiotropium/olodaterol with tiotropium monotherapy in terms of escalation to triple therapy
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