RESEARCH ARTICLE


Real-World Safety and Efficacy of Glycopyrronium Bromide in Japanese Patients with COPD: A 52-Week Post-Marketing Surveillance



Chihiro Kato1, Dong Wang2, Noriko Nakamura1, Takayoshi Sasajima1, Hajime Yoshisue2, *
1 Clinical Development & Analytics, Novartis Pharma K.K., Tokyo, Japan
2 Respiratory Medical Franchise, Novartis Pharma K.K., Tokyo, Japan


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Creative Commons License
© 2022 Kato et al.

open-access license: This is an open access article distributed under the terms of the Creative Commons Attribution 4.0 International Public License (CC-BY 4.0), a copy of which is available at: https://creativecommons.org/licenses/by/4.0/legalcode. This license permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

* Address correspondence to this author at the Respiratory Medical Franchise Dept., Medical Division, Novartis Pharma K.K., Japan; Tel: +818045837231, E-mail: hajime.yoshisue@novartis.com


Abstract

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 FEV1 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.

Keywords: Anticholinergic, Cardiovascular and cerebrovascular, Glycopyrronium, Long-term safety, Post-marketing surveillance, COPD.