Hanada Goro

Izumi Arinobu

Marumo Kazuyoshi

Nakamura Hidenori

Setoguchi Yasuhiro

Tokyo Medical University Institutional Repository / 東京医科大学学術情報リポジトリ

173 3772014 10
P1-10.
The effects and safety of standard therapy for 
COPD patients who were not previously receiving 
maintenance treatment
Yasuhiro Setoguchi 
Arinobu Izumi 
Hanada Goro 
Hidenori Nakamura
Kazuyoshi Marumo
UPLIFT trial showed that tiotropium signi cantly im-
proved lung function, health-related quality of life and 
reduced exacerbations of COPD, but had no effect on the 
primary end-point of rate of decline in FEV1 in the full 
cohort. Several secondary reports have documented 
that tiotropium reduced the rate of decline in pre and 
post-bronchodilator FEV1 in patients who were not pre-
viously receiving any maintenance treatments. The 
Japanese cohort in sub-analysis of UPLIFT showed that 
the rate of decline in FEV1 in Japanese patients treated 
with tiotropium was a comparable rate of decline in 
FEV1 in healthy subjects without COPD 29 mL 44 
per year . In this cohort, over 95% patients experi-
enced medication for COPD. Based on this knowledge, 
we investigated the ef cacy and safety of standard phar-
macological agents for Japanese patients with COPD 
who were not previously receiving any maintenance 
treatment.
Methods Key inclusion criteria were age >40 years, 
smoking history of >10 pack-years, post-bronchodilator 
FEV1/FVC <70% and patients who were not previously 
receiving any maintenance treatment. Key exclusion 
criteria were COPD exacerbations or respiratory infec-
tions within 4 weeks before screening, a history of asth-
ma, prior pulmonary resection or use of supplemental 
oxygen for >12 h/day. Eligible patients were random-
ized to receive standard therapy in accordance with 
GOLD guideline. Spirometry, COPD assessment test 
CAT  as QOL, and Physical functioning scale of 10 
PF 10  were performed every 2 month for 1 year. 
Results and Discussion 49 patients were enrolled in 
this study. Change in pre- and post bronchodilator 
FEV1 was 121 ml before maintenance treatment. An-
nual rate of decline in FEV1 was 20 ml/year which was a 
comparable rate of decline of Japanese patients in 
UPLIFT. CAT score improved, especially score in do-
main of cough and dyspnea showed statistically signi -
cant improvement. PF10 score also improved. The 
proportion of patients with an exacerbation was 0.05/pa-
tient/year, which was much lower than data in Japanese 
patients of UPLIFT 0.37/patient/year , suggesting that 
this group was unsusceptible to exacerbation. Adverse 
events was 43%, which accounted for no serious events 
like a dry mouth.
Conclusion In Japanese patients with COPD who 
who are not on maintenance therapy, standard treatment 
in accordance with GOLD recommendation is associated 
with signi cant bene ts in disease progression.
P1-11.
:
HbA1c
DPP-4
3
2
40 28
7


The effects and safety of standard therapy for COPD patients who were not previously receiving maintenance treatment

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The effects and safety of standard therapy for COPD patients who were not previously receiving maintenance treatment

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