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

Chihiro Kato,Dong Wang,Takayoshi Sasajima,Hajime Yoshisue,Noriko Nakamura

doi:10.2174/18743064-v16-e2112240

Abstract

To evaluate the long-term safety and efficacy of glycopyrronium (GLY) in patients with COPD in a real-world setting in Japan. 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. 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. 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.

Highlights

Chronic obstructive pulmonary disease (COPD) is characterized by persistent airflow limitation and respiratory symptoms that are due to airway and alveolar abnormalities usually caused by significant exposure to noxious particles or gases resulting in increased morbidity and a poor quality of life [1]
Over 50% patients had prior treatment for COPD, with long-acting β2-agonists (LABA) (26.31%) accounting for the highest percentage followed by long-acting muscarinic antagonists (LAMAs) (19.34%) and LABA/inhaled corticosteroids (ICS) in 17.62% (17.62%)
Careful consideration should be given when comparing results from this surveillance with those from randomized controlled trials (RCTs) conducted under standardized conditions with fewer patients and strict enrolment criteria, the observational nature of this study enabled us to collect long-term safety and efficacy data from a larger pool of patients in a more realistic clinical setting

Summary

Introduction

Chronic obstructive pulmonary disease (COPD) is characterized by persistent airflow limitation and respiratory symptoms that are due to airway and alveolar abnormalities usually caused by significant exposure to noxious particles or gases resulting in increased morbidity and a poor quality of life [1]. The Global prevalence of COPD was reported to be around 251 million cases in 2016 [2]. The Global initiative for Chronic Obstructive Lung Disease (GOLD 2020) strategy recommends long-acting muscarinic antagonists (LAMAs) as the first-line therapy for patients with moderate-to-severe COPD (GOLD stages of B, C and D) [1]. In line with GOLD, the Japanese Respiratory Society guidelines recommend treatment with LAMAs as the preferred treatment choice for patients across COPD severity (stage I-IV) [5].

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Discussion

Conclusion