Time to clinical improvement: an appropriate surrogate endpoint for pulmonary arterial hypertension medication trials

Autor: An Wang, Mengqi Chen, Qi Zhuang, Lihua Guan, Weiping Xie, Lan Wang, Wei Huang, Zhaozhong Cheng, Shiyong Yu, Hongmei Zhou, Jieyan Shen
Jazyk: angličtina
Rok vydání: 2023
Předmět:
Zdroj: Frontiers in Cardiovascular Medicine, Vol 10 (2023)
Druh dokumentu: article
ISSN: 2297-055X
DOI: 10.3389/fcvm.2023.1142721
Popis: BackgroundMany retrospective studies suggest that risk improvement may be a suitable efficacy surrogate endpoint for pulmonary arterial hypertension (PAH) medication trials. This prospective multicenter study assessed the efficacy of domestic ambrisentan in Chinese PAH patients and observed risk improvement and time to clinical improvement (TTCI) under ambrisentan treatment.MethodsEligible patients with PAH were enrolled for a 24-week treatment with ambrisentan. The primary efficacy endpoint was 6-min walk distance (Δ6MWD). The exploratory endpoints were risk improvement and TTCI, defined as the time from initiation of treatment to the first occurrence of risk improvement.ResultsA total of 83 subjects were enrolled. After ambrisentan treatment, Δ6MWD was significantly increased at week 12 (42.2 m, P
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