Efficacy and safety of ambrisentan in Chinese patients with connective tissue disease-pulmonary arterial hypertension: a post-hoc analysis

BMC Cardiovascular Disorders

Yong Huo¹  Ping Zhu²  Bingxiang Wu³  Yang Li³  Xiaofeng Zeng⁴  Mengtao Li⁴  Wenjing Zhu⁵  Pingping Wang⁵  Jinhua Zhong⁵  Zhi-Cheng Jing⁶  Qiushang Ji⁷  Jinming Liu⁸  Gangcheng Zhang⁹  Zaixin Yu^1,10 

[1] 1st Affiliated Hospital of Peking University;1st Affiliated Hospital of the Fourth Military Medical University;2nd Affiliated Hospital of Harbin Medical University;Department of Rheumatology, Peking Union Medical College Hospital, Peking Union Medical College & Chinese Academy of Medical Sciences, National Clinical Research Center for Immunologic Diseases, Ministry of Science & Technology, Key Laboratory of Rheumatology and Clinical Immunology, Ministry of Education;GlaxoSmithKline (China) R&D Company Limited;Key Lab of Pulmonary Vascular Medicine & FuWai Hospital, State Key lab of Cardiovascular disease, National center for Cardiovascular disease, Department of Cardiology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College;Qilu Hospital, Shandong University;Shanghai Pulmonary Hospital, Tongji University;Wuhan Asia Heart Hospital;Xiangya Hospital Central-South University;

关键词: Ambrisentan;    Chinese;    Exercise capacity;   

DOI  :  10.1186/s12872-020-01591-1

来源: DOAJ

【 摘 要 】

Abstract Background The efficacy and safety of ambrisentan has been previously evaluated in Chinese patients with pulmonary arterial hypertension (PAH). This post-hoc analysis assessed the efficacy and safety of ambrisentan in a subgroup of connective tissue disease (CTD) patients with PAH. Methods In this open-label, single-arm study, patients received ambrisentan 5 mg once daily for 12 weeks, followed by 12-week dose titration period (dose up to 10 mg). Efficacy endpoints included change from baseline in exercise capacity (measured by 6-min walk test [6MWT]), N-terminal pro B type natriuretic peptide (NT-proBNP) plasma levels, WHO Functional Class (FC) and Borg Dyspnoea Index (BDI) scores from baseline to weeks 12 and 24. Safety endpoints included time to clinical worsening and incidence of adverse events (AEs). Results In total, 71 Chinese patients with CTD-PAH were included in this analysis. Ambrisentan treatment significantly improved exercise capacity (6MWT) from baseline (mean: 366.4 m) to week 12 (63.8 m, p < 0.001) and week 24 (73.2 m, p < 0.001). A significant reduction in NT-proBNP levels was observed from baseline (mean: 1837.5 ng/L) to week 12 (− 1156.8 ng/L, p < 0.001) and week 24 (− 1095.5 ng/L, p < 0.001). BDI scores decreased significantly at week 12 (− 0.6, p < 0.001) and week 24 (− 0.4, p = 0.002) from baseline (mean: 2.7). The WHO FC improved in 29 (40.8%) and 34 (47.9%) patients at weeks 12 and 24, respectively. Adverse events were reported in 52 (73.2%) patients. One patient (1.4%) experienced clinical worsening at week 24. Conclusion Ambrisentan showed significant improvement in exercise capacity and no clinical worsening in the majority of Chinese patients with CTD-PAH in the 24-week treatment period. The AEs observed in the CTD-PAH subgroup were consistent with the known safety profile of ambrisentan in the overall Chinese PAH population. Trial registration ClinicalTrial.gov Identifier, https://clinicaltrials.gov/, NCT01808313 Registration date (first time): February 28, 2013.

【 授权许可】

Unknown