PMID- 36437604
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20230112
IS  - 1738-3536 (Print)
IS  - 2005-6184 (Electronic)
IS  - 1738-3536 (Linking)
VI  - 86
IP  - 1
DP  - 2023 Jan
TI  - An Open-Label, Multicentre, Observational, Post-Marketing Study to Monitor the 
      Safety and Effectiveness of Umeclidinium/Vilanterol in Korean Patients.
PG  - 33-46
LID - 10.4046/trd.2022.0055 [doi]
AB  - BACKGROUND: Umeclidinium/vilanterol (UMEC/VI; ANORO ELLIPTA, GSK) is a commonly 
      used dual bronchodilator. This study evaluated the safety and effectiveness of 
      UMEC/VI in Korean patients with chronic obstructive pulmonary disease (COPD) over 
      a 6-year period. METHODS: This was an open-label, multicentre, observational, 
      post-marketing surveillance study. A total of 3,375 patients were enrolled 
      consecutively in 52 hospitals, by 53 physicians, between July 2014 and July 2020. 
      Patients who were administered UMEC/VI (fixed-dose 62.5 mug/25 mug) at least once 
      and were monitored for safety and effectiveness were included in the analysis. 
      Incidence and severity of adverse events (AEs) reported after administrating at 
      least one dose of UMEC/VI were monitored, including unexpected adverse events 
      (UAEs) and adverse drug reactions (ADRs). Effectiveness of UMEC/VI after 24 weeks 
      of administration was also assessed using physician's evaluation (effective, 
      ineffective/no change, worsening, indeterminable) and lung function improvement. 
      RESULTS: Of 3,375 patients, 3,086 were included in the safety assessment group 
      (mean age+/-standard deviation: 69.76+/-8.80 years; 85.9% male [n=2,652]; 73.1% aged 
      >/=65 years [n=2,255]). The overall incidence of AEs was 28.8% (n=890), of which 
      2.2% (n=67) were ADRs. Serious AEs and UAEs were reported in 181 (5.9%) and 665 
      (21.6%) patients, respectively, and two patients (<0.1%) reported unexpected 
      severe ADR. Of the 903/3,086 patients analysed for effectiveness, most (82.8%, 
      n=748) showed overall disease improvement after UMEC/VI treatment. CONCLUSION: 
      This study confirmed UMEC/VI administered to Korean patients according to the 
      prescribing information was well-tolerated and can be considered an effective 
      option for COPD treatment.
FAU - Cho, Eun-Yeong
AU  - Cho EY
AD  - GSK Korea, Seoul, Republic of Korea.
FAU - Cho, Jung-Eun
AU  - Cho JE
AD  - GSK Korea, Seoul, Republic of Korea.
FAU - Lee, Eun-Bin
AU  - Lee EB
AD  - GSK Korea, Seoul, Republic of Korea.
FAU - Yoo, Seung Soo
AU  - Yoo SS
AD  - Department of Internal Medicine, School of Medicine, Kyungpook National 
      University, Kyungpook National University Hospital, Daegu, Republic of Korea.
FAU - Chang, Jung Hyun
AU  - Chang JH
AD  - Division of Pulmonary and Critical Care Medicine, Ewha Womans University College 
      of Medicine, Seoul, Republic of Korea.
LA  - eng
GR  - 204511/WT_/Wellcome Trust/United Kingdom
PT  - Journal Article
DEP - 20221128
PL  - Korea (South)
TA  - Tuberc Respir Dis (Seoul)
JT  - Tuberculosis and respiratory diseases
JID - 101479418
PMC - PMC9816489
OTO - NOTNLM
OT  - GSK573719
OT  - Postmarketing
OT  - Pulmonary Disease, Chronic Obstructive
OT  - Safety
OT  - Vilanterol
COIS- Conflicts of Interest Eun-Yeong Cho was an employee and shareholder, Jung-Eun 
      Cho, and Eun-Bin Lee are employees of GSK. Seung Soo Yoo and Jung Hyun Chang 
      disclosed no conflict of interests.
EDAT- 2022/11/29 06:00
MHDA- 2022/11/29 06:01
PMCR- 2023/01/01
CRDT- 2022/11/28 02:04
PHST- 2022/04/21 00:00 [received]
PHST- 2022/09/25 00:00 [accepted]
PHST- 2022/11/29 06:00 [pubmed]
PHST- 2022/11/29 06:01 [medline]
PHST- 2022/11/28 02:04 [entrez]
PHST- 2023/01/01 00:00 [pmc-release]
AID - trd.2022.0055 [pii]
AID - trd-2022-0055 [pii]
AID - 10.4046/trd.2022.0055 [doi]
PST - ppublish
SO  - Tuberc Respir Dis (Seoul). 2023 Jan;86(1):33-46. doi: 10.4046/trd.2022.0055. Epub 
      2022 Nov 28.