Open AccessReal-World Safety and Efficacy of Glycopyrronium Bromide in Japanese Patients with COPD: A 52-Week Post-Marketing Surveillance
Author(s) -
Chiho Kato,
Dong Wang,
Noriko Nakamura,
Takayoshi Sasajima,
Hajime Yoshisue
Publication year - 2022
Publication title -
the open respiratory medicine journal
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.341
H-Index - 19
ISSN - 1874-3064
DOI - 10.2174/18743064-v16-e2112240
Subject(s) - medicine , adverse effect , incidence (geometry) , copd , anticholinergic , postmarketing surveillance , population , environmental health , physics , optics
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.