PMID- 28119747
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20201001
IS  - 1738-3536 (Print)
IS  - 2005-6184 (Electronic)
IS  - 1738-3536 (Linking)
VI  - 80
IP  - 1
DP  - 2017 Jan
TI  - Safety and Effectiveness of Indacaterol in Chronic Obstructive Pulmonary Disease 
      Patients in South Korea.
PG  - 52-59
LID - 10.4046/trd.2017.80.1.52 [doi]
AB  - BACKGROUND: Inhaled indacaterol (Onbrez Breezhaler), a long-acting beta(2)-agonist, 
      is approved in over 100 countries, including South Korea, as a once-daily 
      bronchodilator for maintenance and treatment of chronic obstructive pulmonary 
      disease (COPD). Here, we present an interim analysis of a post-marketing 
      surveillance study conducted to evaluate the real-world safety and effectiveness 
      of indacaterol in the Korean population. METHODS: This was an open-label, 
      observational, prospective study in which COPD patients, who were newly 
      prescribed with indacaterol (150 or 300 microg), were evaluated for 12 or 24 weeks. 
      Safety was assessed based on the incidence rates of adverse events (AEs) and 
      serious adverse events (SAEs). Effectiveness was evaluated based on physician's 
      assessment by considering changes in symptoms and lung function, if the values of 
      forced expiratory volume in 1 second were available. RESULTS: Safety data were 
      analyzed in 1,016 patients of the 1,043 enrolled COPD patients receiving 
      indacaterol, and 784 patients were included for the effectiveness analysis. AEs 
      were reported in 228 (22.44%) patients, while 98 (9.65%) patients reported SAEs. 
      The COPD condition improved in 348 patients (44.4%), while the condition was 
      maintained in 396 patients (50.5%), and only 40 patients (5.1%) exhibited 
      worsening of ailment as compared with baseline. During the treatment period, 90 
      patients were hospitalized while nine patients died. All deaths were assessed to 
      be not related to the study drug by the investigator. CONCLUSION: In real-life 
      clinical practice in South Korea, indacaterol was well tolerated in COPD 
      patients, and can be regarded as an effective option for their maintenance 
      treatment.
FAU - Yum, Ho-Kee
AU  - Yum HK
AD  - Department of Internal Medicine, Inje University Seoul Paik Hospital, Inje 
      University College of Medicine, Seoul, Korea.
FAU - Kim, Hak-Ryul
AU  - Kim HR
AD  - Department of Internal Medicine, Wonkwang University School of Medicine, Iksan, 
      Korea.
FAU - Chang, Yoon Soo
AU  - Chang YS
AD  - Department of Internal Medicine, Yonsei University College of Medicine, Seoul, 
      Korea.
FAU - Shin, Kyeong-Cheol
AU  - Shin KC
AD  - Division of Pulmonology and Allergy, Department of Internal Medicine, Regional 
      Center for Respiratory Disease, Yeungnam University College of Medicine, Daegu, 
      Korea.
FAU - Kim, Song
AU  - Kim S
AD  - Novartis Korea Ltd., Seoul, Korea.
FAU - Oh, Yeon-Mok
AU  - Oh YM
AD  - Department of Pulmonary and Critical Care Medicine, Asan Medical Center, 
      University of Ulsan College of Medicine, Seoul, Korea.
LA  - eng
PT  - Journal Article
DEP - 20161230
PL  - Korea (South)
TA  - Tuberc Respir Dis (Seoul)
JT  - Tuberculosis and respiratory diseases
JID - 101479418
PMC - PMC5256353
OTO - NOTNLM
OT  - Bronchodilator Agents
OT  - Indacaterol
OT  - Pulmonary Disease, Chronic Obstructive
OT  - Safety
OT  - South Korea
OT  - Therapeutics
COIS- Y.-M.O. has received honoraria/consulting fees for Dong-Wha, MSD Korea, 
      AstraZeneca Korea, GlaxoSmithKline Korea, Novartis, Boehringer-Ingelheim Korea in 
      the recent 3 years. All investigators (H.-K.Y., H.-R.K., Y.S.C., K.-C.S., and 
      Y.-M.O.) received fees from Novartis for conducting the study. S.K. is a Novartis 
      employee.
EDAT- 2017/01/26 06:00
MHDA- 2017/01/26 06:01
PMCR- 2017/01/01
CRDT- 2017/01/26 06:00
PHST- 2016/02/23 00:00 [received]
PHST- 2016/04/12 00:00 [revised]
PHST- 2016/06/22 00:00 [accepted]
PHST- 2017/01/26 06:00 [entrez]
PHST- 2017/01/26 06:00 [pubmed]
PHST- 2017/01/26 06:01 [medline]
PHST- 2017/01/01 00:00 [pmc-release]
AID - 10.4046/trd.2017.80.1.52 [doi]
PST - ppublish
SO  - Tuberc Respir Dis (Seoul). 2017 Jan;80(1):52-59. doi: 10.4046/trd.2017.80.1.52. 
      Epub 2016 Dec 30.