Yu-Cheng Chen, Hai-Long Dai, Chun-Li Liu, Jiang Li, Qiu-Shang Ji, Yun-Shan Cao, Jing Xiao, Rong Jian, Jian-Min Zhuo, Xin-Chao Luo, Hong Gu
West China Hospital of Sichuan University. Yan’an Affiliated Hospital of Kunming Medical University. First Affiliated Hospital of Guangzhou Medical University. Second Xiangya Hospital of Central South University. Qilu Hospital of Shandong University. Gansu Provincial Hospital. Xi’an Janssen Pharmaceutical Ltd. Beijing Anzhen Hospital.
China
Current Medical Research and Opinion
Curr Med Res Opin 2024;
DOI: 10.1080/03007995.2024.2349733
Abstract
Background: Macitentan, either as monotherapy or part of combination therapy, improved clinical outcomes in patients with pulmonary artery hypertension (PAH) in clinical trials. Evidence on the effectiveness and safety of macitentan administered in real-world clinical practice in China is limited.
Methods: This real-world, retrospective, multicenter chart review study was conducted at seven hospitals in China. Adult patients with a diagnosis of PAH who initiated macitentan and had medical assessments at 3-7 months after macitentan initiation were included. The primary outcomes were changes in the World Health Organization functional class (WHO-FC), 6-minute walk distance (6MWD), and N-terminal pro-B-type natriuretic peptide/B-type natriuretic peptide (NT-proBNP/BNP) from baseline to first follow-up visit (months 3-7). Serious adverse events (SAEs) and adverse drug reactions (ADRs) of macitentan were collected.
Results: From 30 August 2021 to 31 March 2022, 214 eligible patients were included in the safety analysis set and 105 patients were included in the analysis of effectiveness. At the first follow-up visit compared with baseline, significant changes in WHO-FC were observed (p = .04), 93.5% patients had their WHO-FC improved (25.8%) or maintained (67.7%). 6MWD changed by a mean (standard deviation [SD]) of 45.0 (81.4) meters (p < .001), with 94.7% having their 6MWD improved (34.7%) or maintained (60.0%). The mean (SD) of NT-proBNP decreased from 1667.4 (3233.0) ng/L to 1090.0 (2230.1) ng/L (p < .001). In the safety analysis set, 24 (11.2%) patients experienced at least one ADR and/or SAE. ADRs and SAEs were reported in 11 (5.1%) and 18 (8.4%), respectively. No deaths or unexpected safety events were observed.
Conclusion: This study provided real-world evidence on the clinical benefits and good tolerance of macitentan in Chinese patients with PAH treated in routine clinical practice.
Category
Medical Therapy. Efficacy or Lack of Efficacy
Medical Therapy. Adverse Effects or Lack of Adverse Effects
Age Focus: Adult Pulmonary Vascular Disease
Fresh or Filed Publication: Fresh (PHresh). Less than 1-2 years since publication
Article Access
Free PDF File or Full Text Article Available Through PubMed or DOI: No