PMID- 37273944
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20230606
IS  - 1874-3064 (Print)
IS  - 1874-3064 (Electronic)
IS  - 1874-3064 (Linking)
VI  - 16
DP  - 2022
TI  - Real-World Safety and Efficacy of Glycopyrronium Bromide in Japanese Patients 
      with COPD: A 52-Week Post-Marketing Surveillance.
PG  - e187430642112240
LID - 10.2174/18743064-v16-e2112240 [doi]
LID - e187430642112240
AB  - OBJECTIVE: To evaluate the long-term safety and efficacy of glycopyrronium (GLY) 
      in patients with COPD in a real-world setting in Japan. METHODS: This 52-week, 
      multicentre, post-marketing surveillance conducted in Japan, between February 
      2013 and August 2019, included patients using GLY for the first time for the 
      relief of airway obstructive disorder-related symptoms. Safety outcomes included 
      incidence of adverse events (AEs), serious AEs (SAEs), adverse drug reactions 
      (ADRs), serious ADRs (SADRs) and priority variables included 
      cardiovascular/cerebrovascular (CCV) AEs and anticholinergic AEs during the 
      52-week period. Safety outcomes were also assessed in elderly patients. Efficacy 
      outcomes included physician's global assessment, COPD assessment test (CAT) and 
      lung function test. RESULTS AND DISCUSSION: Of the 1,331 patients registered for 
      this surveillance, safety and efficacy outcomes were evaluated in 1,277 patients. 
      In the safety analysis population, the incidence of AEs was 15.51%, SAEs 4.70%, 
      ADRs 5.01% and SADRs 0.31%. The CCV AEs and anticholinergic AEs were reported by 
      0.70% and 2.58% patients, respectively. Physician's global assessment showed that 
      the overall response rate at the last assessment was 70%. The mean (95% CI) CAT 
      scores decreased from the start of treatment to Week 52 with GLY, (-6.2 [-7.0 to 
      -5.4]). Lung function in terms of trough FEV(1) and FVC improved over time from 
      the start of GLY to Week 52. CONCLUSION: GLY demonstrated an acceptable long-term 
      safety profile with no new safety concerns in a real-life setting. It 
      demonstrated improvement in lung function and symptom control in Japanese COPD 
      patients.
CI  - (c) 2022 Kato et al.
FAU - Kato, Chihiro
AU  - Kato C
AD  - Clinical Development & Analytics, Novartis Pharma K.K., Tokyo, Japan.
FAU - Wang, Dong
AU  - Wang D
AD  - Respiratory Medical Franchise, Novartis Pharma K.K., Tokyo, Japan.
FAU - Nakamura, Noriko
AU  - Nakamura N
AD  - Clinical Development & Analytics, Novartis Pharma K.K., Tokyo, Japan.
FAU - Sasajima, Takayoshi
AU  - Sasajima T
AD  - Clinical Development & Analytics, Novartis Pharma K.K., Tokyo, Japan.
FAU - Yoshisue, Hajime
AU  - Yoshisue H
AD  - Respiratory Medical Franchise, Novartis Pharma K.K., Tokyo, Japan.
LA  - eng
PT  - Journal Article
DEP - 20220208
PL  - United Arab Emirates
TA  - Open Respir Med J
JT  - The open respiratory medicine journal
JID - 101480481
PMC - PMC10156031
OTO - NOTNLM
OT  - Anticholinergic
OT  - COPD
OT  - Cardiovascular and cerebrovascular
OT  - Glycopyrronium
OT  - Long-term safety
OT  - Post-marketing surveillance
COIS- Chihiro Kato, Dong Wang, Noriko Nakamura, Takayoshi Sasajima, and Hajime Yoshisue 
      are the employees of Novartis Pharma K.K., Tokyo, Japan.
EDAT- 2022/02/08 00:00
MHDA- 2022/02/08 00:01
PMCR- 2022/01/01
CRDT- 2023/06/05 11:54
PHST- 2021/07/25 00:00 [received]
PHST- 2021/11/10 00:00 [revised]
PHST- 2021/11/17 00:00 [accepted]
PHST- 2022/02/08 00:01 [medline]
PHST- 2022/02/08 00:00 [pubmed]
PHST- 2023/06/05 11:54 [entrez]
PHST- 2022/01/01 00:00 [pmc-release]
AID - TORMJ-16-e187430642112240 [pii]
AID - 10.2174/18743064-v16-e2112240 [doi]
PST - epublish
SO  - Open Respir Med J. 2022 Feb 8;16:e187430642112240. doi: 
      10.2174/18743064-v16-e2112240. eCollection 2022.