PMID- 37651085
OWN - NLM
STAT- MEDLINE
DCOM- 20231023
LR  - 20231023
IS  - 1179-1942 (Electronic)
IS  - 0114-5916 (Linking)
VI  - 46
IP  - 10
DP  - 2023 Oct
TI  - Real-World Safety and Effectiveness of Fluticasone Furoate/Vilanterol in Patients 
      with Asthma and/or Chronic Obstructive Pulmonary Disease: A Post-Marketing Study 
      in Korea.
PG  - 951-960
LID - 10.1007/s40264-023-01337-w [doi]
AB  - BACKGROUND AND OBJECTIVE: Fluticasone furoate/vilanterol (FF/VI; RELVAR ELLIPTA) 
      is approved in Korea for patients with asthma or chronic obstructive pulmonary 
      disease (COPD). This study evaluated the effectiveness and safety of FF/VI in 
      Korean patients with asthma and/or COPD over a 6-year period. METHODS: This was 
      an open-label, multicentre, observational, post-marketing surveillance study in 
      patients newly treated with FF/VI (100 or 200 mug/25 mug once daily). Safety 
      endpoints were the incidence of adverse events (AEs), including unexpected 
      AEs/adverse drug reactions (ADRs) and serious AEs/ADRs. Effectiveness was 
      assessed after 24 weeks by Global Physician Assessment (logistic regression) and 
      forced expiratory volume in 1 s (FEV(1); paired t-tests). RESULTS: Of the 3426 
      patients enrolled across 45 hospitals between July 2014 and June 2020, 3216 were 
      included in the safety analysis (50.5% female; mean age +/- standard deviation 
      [SD]: 58.6 +/- 16.3 years). Overall incidence of AEs was 30.9% (n = 992); 4.1% (n = 
      132) were ADRs. Serious AEs were reported in 4.1% (n = 132) of patients; 0.1% (n 
      = 4) were ADRs. Of 1543 patients analysed for symptomatic improvement, 89.2% (n = 
      1377) improved, 9.4% (n = 145) were unchanged, and 1.4% (n = 21) worsened. Mean 
      FEV(1) (difference +/- SD) increased significantly in patients with asthma (0.09 +/- 
      0.29 L; p < 0.0001), COPD (0.11 +/- 0.24 L; p = 0.0011), or both (0.05 +/- 0.18 L; p 
      = 0.0399), indicating improved lung function. CONCLUSION: In this real-world 
      study, FF/VI administered to Korean patients was well tolerated and effective for 
      the treatment of asthma and COPD. These results were consistent with other 
      studies in Asian and global populations.
CI  - (c) 2023. The Author(s), under exclusive licence to Springer Nature Switzerland AG.
FAU - Cho, Eun-Yeong
AU  - Cho EY
AD  - Sinchon Yonsei Hospital, 110, Seogang-ro, Mapo-gu, Seoul, 04094, Republic of 
      Korea. triangle702@gmail.com.
FAU - Cho, Jung-Eun
AU  - Cho JE
AD  - GSK Korea, Seoul, Republic of Korea.
FAU - Jang, Seung Hun
AU  - Jang SH
AD  - Hallym University Sacred Heart Hospital, Hallym University College of Medicine, 
      Anyang, Republic of Korea.
FAU - Hwang, Ki-Eun
AU  - Hwang KE
AD  - Wonkwang University School of Medicine, Iksan, Republic of Korea.
LA  - eng
PT  - Journal Article
PT  - Observational Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20230831
PL  - New Zealand
TA  - Drug Saf
JT  - Drug safety
JID - 9002928
RN  - JS86977WNV (fluticasone furoate)
RN  - 028LZY775B (vilanterol)
RN  - 0 (Drug Combinations)
SB  - IM
MH  - Humans
MH  - Female
MH  - Male
MH  - Drug Combinations
MH  - Administration, Inhalation
MH  - *Pulmonary Disease, Chronic Obstructive/drug therapy
MH  - *Asthma/drug therapy
MH  - Republic of Korea/epidemiology
MH  - Treatment Outcome
EDAT- 2023/08/31 12:43
MHDA- 2023/10/23 00:42
CRDT- 2023/08/31 11:17
PHST- 2023/07/12 00:00 [accepted]
PHST- 2023/10/23 00:42 [medline]
PHST- 2023/08/31 12:43 [pubmed]
PHST- 2023/08/31 11:17 [entrez]
AID - 10.1007/s40264-023-01337-w [pii]
AID - 10.1007/s40264-023-01337-w [doi]
PST - ppublish
SO  - Drug Saf. 2023 Oct;46(10):951-960. doi: 10.1007/s40264-023-01337-w. Epub 2023 Aug 
      31.