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.jpg): Failed to open stream: No such file or directory in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 117 Int+J+Chron+Obstruct+Pulmon+Dis
2018 ; 13
(ä): 2147-2156
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Tiotropium/olodaterol versus tiotropium in Japanese patients with COPD: results
from the DYNAGITO study
#MMPMID30034230
Ichinose M
; Nishimura M
; Akimoto M
; Kurotori Y
; Zhao Y
; de la Hoz A
; Mishima M
Int J Chron Obstruct Pulmon Dis
2018[]; 13
(ä): 2147-2156
PMID30034230
show ga
BACKGROUND: The DYNAGITO study was a Phase IIIb, randomized, double-blind,
multicenter, active-controlled, parallel-group, 52-week study designed to
determine the efficacy and safety of tiotropium and olodaterol combination
therapy (TIO+OLO 5/5 ?g) versus tiotropium monotherapy (TIO 5 ?g) for reducing
moderate-to-severe exacerbations of COPD. This is a prespecified analysis of the
DYNAGITO data in Japanese patients. PATIENTS AND METHODS: Enrolled patients had a
diagnosis of COPD with at least one moderate-to-severe exacerbation in the
previous 12 months. Of the total 7,880 treated patients in the DYNAGITO study,
461 (TIO+OLO 5/5 ?g: n=226, TIO 5 ?g: n=235) were Japanese. The primary endpoint
was the annualized rate of moderate-to-severe COPD exacerbations. The key
secondary endpoint was the time to first moderate-to-severe COPD exacerbation,
and other secondary endpoints included the annualized rate of exacerbations
leading to hospitalization, time to first COPD exacerbation leading to
hospitalization, and all-cause mortality. Safety data were analyzed
descriptively. RESULTS: Combination therapy with TIO+OLO resulted in a 29% lower
rate of moderate-to-severe COPD exacerbations relative to TIO monotherapy (rate
ratio 0.71; 99% CI: 0.46, 1.10; p=0.0434). The risk of a first moderate-to-severe
COPD exacerbation was 19% lower with TIO+OLO combination therapy than with TIO
monotherapy (HR 0.81; 99% CI: 0.57, 1.17; p=0.1379), although this difference was
not statistically significant. The annualized rate of COPD exacerbations
requiring hospitalization was 14% lower in the TIO+OLO arm than in the TIO arm
(rate ratio 0.86; 95% CI: 0.52, 1.42; p=0.5654). The adverse event incidence was
balanced between treatment arms. CONCLUSION: In a prespecified subgroup analysis
of Japanese patients in the DYNAGITO study, combination therapy with TIO+OLO was
more effective than TIO in reducing exacerbations. Both treatments were well
tolerated.
|*Disease Progression
[MESH]
|Administration, Inhalation
[MESH]
|Aged
[MESH]
|Benzoxazines/administration & dosage/*therapeutic use
[MESH]