Effect of tiotropium on lung function decline in early-stage of chronic obstructive pulmonary disease patients: propensity score-matched analysis of real-world data.
BACKGROUND
Tiotropium failed to slow the annual rate of forced expiratory volume in 1 second (FEV1) decline in chronic obstructive pulmonary disease (COPD) patients with <70% predicted FEV1. However, the rate of FEV1 decline is known to be faster at early stages, which suggests that the effects of tiotropium may be more prominent in early-stage of COPD patients. The aim of this study was to test the hypothesis that tiotropium modifies the rate of FEV1 decline in COPD patients with an FEV1≥70%.


METHODS
We retrospectively reviewed the records of COPD patients diagnosed between January 1, 2004, and July 31, 2012, at Seoul National University Hospital, Seoul National University Bundang Hospital, and Seoul Metropolitan Government-Seoul National University Boramae Medical Center. The inclusion criteria were as follows: age ≥40 years, postbron-chodilator (BD) FEV1≥70% of predicted and FEV1/FVC (forced vital capacity) <0.70, and spirometry more than two times at certain times of the year. Conversely, the exclusion criteria were as follows: asthma, lung cancer, pulmonary tuberculosis, pulmonary resection, or long-term use of a short-acting muscarinic antagonist. The annual lung function decline in patients using tiotropium was compared with that in patients not using the drug.


RESULTS
Of the 587 patients enrolled in the study, 257 took tiotropium. Following propensity score matching, 404 patients were included in the analysis. The mean annual rate of post-BD FEV1 decline was 23.9 (tiotropium) and 22.5 (control) mL/yr (P=0.86); corresponding pre-BD values were 30.4 and 21.9 mL/yr (P=0.31), respectively. Mean annual rate of post-BD FVC decline was 55.1 (tiotropium) and 43.5 (control) mL/yr (P=0.33); corresponding pre-BD values were 37.1 and 33.3 mL/yr (P=0.13).


CONCLUSIONS
Therefore, tiotropium does not reduce the rate of lung function decline in COPD patients with FEV1≥70%.
Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Seoul National University Hospital, Seoul, Republic of Korea ; Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Republic of Korea.
Ha Youn
HY
Lee
Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Seoul National University Hospital, Seoul, Republic of Korea ; Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Republic of Korea.
Sun Mi
SM
Choi
Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Seoul National University Hospital, Seoul, Republic of Korea ; Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Republic of Korea.
Jinwoo
J
Lee
Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Seoul National University Hospital, Seoul, Republic of Korea ; Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Republic of Korea.
Young Sik
YS
Park
Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Seoul National University Hospital, Seoul, Republic of Korea ; Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Republic of Korea.
Chang-Hoon
CH
Lee
Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Republic of Korea ; Department of Internal Medicine, Seoul Metropolitan Government-Seoul National University Boramae Medical Center, Seoul, Republic of Korea.
Deog Kyeom
DK
Kim
Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Seoul National University Hospital, Seoul, Republic of Korea ; Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Republic of Korea.
Sang-Min
SM
Lee
Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Republic of Korea ; Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Republic of Korea.
Ho Il
HI
Yoon
Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Seoul National University Hospital, Seoul, Republic of Korea ; Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Republic of Korea.
Jae-Joon
JJ
Yim
Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Seoul National University Hospital, Seoul, Republic of Korea ; Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Republic of Korea.
Young Whan
YW
Kim
Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Seoul National University Hospital, Seoul, Republic of Korea ; Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Republic of Korea.
Sung Koo
SK
Han
Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Seoul National University Hospital, Seoul, Republic of Korea ; Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Republic of Korea.
Chul-Gyu
CG
Yoo
D000280:Administration, Inhalation; D000368:Aged; D001993:Bronchodilator Agents / Q000627:therapeutic use; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D062072:Patient Acuity; D011379:Prognosis; D057216:Propensity Score; D029424:Pulmonary Disease, Chronic Obstructive / Q000175:diagnosis / Q000188:drug therapy / Q000453:epidemiology / Q000503:physiopathology; D056910:Republic of Korea / Q000453:epidemiology; D012129:Respiratory Function Tests / Q000379:methods / Q000706:statistics & numerical data; D012189:Retrospective Studies; D000069447:Tiotropium Bromide / Q000627:therapeutic use*; D016896:Treatment Outcome
D001993:Bronchodilator Agents; D000069447:Tiotropium Bromide
chronic obstructive pulmonary disease; lung function decline; tiotropium