PMID- 27189287
OWN - NLM
STAT- MEDLINE
DCOM- 20161213
LR  - 20221207
IS  - 1976-2437 (Electronic)
IS  - 0513-5796 (Print)
IS  - 0513-5796 (Linking)
VI  - 57
IP  - 4
DP  - 2016 Jul
TI  - Efficacy and Safety of Roflumilast in Korean Patients with COPD.
PG  - 928-35
LID - 10.3349/ymj.2016.57.4.928 [doi]
AB  - PURPOSE: Roflumilast is the only oral phosphodiesterase 4 inhibitor approved to 
      treat chronic obstructive pulmonary disease (COPD) patients [post-bronchodilator 
      forced expiratory volume in 1 second (FEV(1)) <50% predicted] with chronic 
      bronchitis and a history of frequent exacerbations. This study evaluated the 
      efficacy and safety of roflumilast in Korean patients with COPD and compared the 
      efficacy based on the severity of airflow limitation. MATERIALS AND METHODS: A 
      post-hoc subgroup analysis was performed in Korean COPD patients participating in 
      JADE, a 12-week, double-blinded, placebo-controlled, parallel-group, phase III 
      trial in Asia. The primary efficacy endpoint was the mean [least-squares mean 
      adjusted for covariates (LSMean)] change in post-bronchodilator FEV(1) from 
      baseline to each post-randomization visit. Safety endpoints included adverse 
      events (AEs) and changes in laboratory values, vital signs, and 
      electrocardiograms. RESULTS: A total of 260 Korean COPD patients were recruited, 
      of which 207 were randomized to roflumilast (n=102) or placebo (n=105) treatment. 
      After 12 weeks, LSMean post-bronchodilator FEV(1) increased by 43 mL for patients 
      receiving roflumilast and decreased by 60 mL for those taking placebo. Adverse 
      events were more common in the roflumilast group than in the placebo group; 
      however, the types and frequency of AEs were comparable to those reported in 
      previous studies. CONCLUSION: Roflumilast significantly improved lung function 
      with a tolerable safety profile in Korean COPD patients irrespective of the 
      severity of airflow limitation.
FAU - Lee, Jae Seung
AU  - Lee JS
AD  - Department of Pulmonary and Critical Care Medicine and Clinical Research Center 
      for Chronic Obstructive Airway Diseases, Asan Medical Center, University of Ulsan 
      College of Medicine, Seoul, Korea.
FAU - Hong, Yoon Ki
AU  - Hong YK
AD  - Department of Internal Medicine, Kangwon National University College of Medicine, 
      Chuncheon, Korea.
FAU - Park, Tae Sun
AU  - Park TS
AD  - Department of Pulmonary and Critical Care Medicine and Clinical Research Center 
      for Chronic Obstructive Airway Diseases, Asan Medical Center, University of Ulsan 
      College of Medicine, Seoul, Korea.
FAU - Lee, Sei Won
AU  - Lee SW
AD  - Department of Pulmonary and Critical Care Medicine and Clinical Research Center 
      for Chronic Obstructive Airway Diseases, Asan Medical Center, University of Ulsan 
      College of Medicine, Seoul, Korea.
FAU - Oh, Yeon Mok
AU  - Oh YM
AD  - Department of Pulmonary and Critical Care Medicine and Clinical Research Center 
      for Chronic Obstructive Airway Diseases, Asan Medical Center, University of Ulsan 
      College of Medicine, Seoul, Korea.
FAU - Lee, Sang Do
AU  - Lee SD
AD  - Department of Pulmonary and Critical Care Medicine and Clinical Research Center 
      for Chronic Obstructive Airway Diseases, Asan Medical Center, University of Ulsan 
      College of Medicine, Seoul, Korea. sdlee@amc.seoul.kr.
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PL  - Korea (South)
TA  - Yonsei Med J
JT  - Yonsei medical journal
JID - 0414003
RN  - 0 (Aminopyridines)
RN  - 0 (Benzamides)
RN  - 0 (Cyclopropanes)
RN  - 0 (Phosphodiesterase 4 Inhibitors)
RN  - 0P6C6ZOP5U (Roflumilast)
SB  - IM
MH  - Aged
MH  - Aminopyridines/*therapeutic use
MH  - *Asian People
MH  - Benzamides/*therapeutic use
MH  - Cyclopropanes/therapeutic use
MH  - Double-Blind Method
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Phosphodiesterase 4 Inhibitors/*therapeutic use
MH  - Pulmonary Disease, Chronic Obstructive/*drug therapy/*ethnology/physiopathology
MH  - Republic of Korea
MH  - Respiratory Function Tests
MH  - Treatment Outcome
PMC - PMC4951470
OTO - NOTNLM
OT  - Chronic obstructive pulmonary disease
OT  - Korea
OT  - roflumilast
OT  - safety
OT  - treatment efficacy
COIS- Conflict of interest statement: The authors have no financial conflicts of 
      interest. YM Oh received payment for lecturing from MSD Korea, AstraZeneca Korea, 
      Boehringer Ingelheim Korea, Novartis, DongWha, Takeda, and GSK Korea. SD Lee 
      received support from Takeda Pharmaceuticals International GmbH for travel to an 
      investigator meeting. He received payment from Takeda Pharmaceuticals 
      International GmbH for attendance at an advisory board. He also received 
      honoraria from GlaxoSmithKline, AstraZeneca, and Boehringer Ingelheim.
EDAT- 2016/05/18 06:00
MHDA- 2016/12/15 06:00
PMCR- 2016/07/01
CRDT- 2016/05/19 06:00
PHST- 2015/06/24 00:00 [received]
PHST- 2015/12/03 00:00 [revised]
PHST- 2015/11/17 00:00 [accepted]
PHST- 2016/05/19 06:00 [entrez]
PHST- 2016/05/18 06:00 [pubmed]
PHST- 2016/12/15 06:00 [medline]
PHST- 2016/07/01 00:00 [pmc-release]
AID - 57.928 [pii]
AID - 10.3349/ymj.2016.57.4.928 [doi]
PST - ppublish
SO  - Yonsei Med J. 2016 Jul;57(4):928-35. doi: 10.3349/ymj.2016.57.4.928.