Evidence map›Paper›PMID 32680480›Full record

Trial reportBMC cardiovascular disorders2020

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

Mengtao Li, Zhi-Cheng Jing, Yang Li, Yong Huo, Zaixin Yu, Gangcheng Zhang, Ping Zhu, Jinming Liu, Qiushang Ji, Bingxiang Wu and 4 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIIMulticenter Study
In one paragraph

Trial report in BMC cardiovascular disorders, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01808313 (An Open Label Phase IIIb Study to Evaluate Efficacy and Safety of Ambrisentan in Chinese Patients With Pulmonary Arterial Hypertension), which is not on this map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 pooled it
0.1field-weighted citation impact, top 48% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01808313 phase3completednot on this map

An Open Label Phase IIIb Study to Evaluate Efficacy and Safety of Ambrisentan in Chinese Patients With Pulmonary Arterial Hypertension (PAH)

TypeinterventionalSponsorGlaxoSmithKlineRan2012 to 2014Enrolled134ConditionsVascular DiseaseArmsambrisentan
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 1 synthesis or guideline pooled it, 2 citations in OpenAlex.

  1. Management of pulmonary arterial hypertension in systemic sclerosis: from classical treatments to new horizons.European respiratory review : an official journal of the European Respiratory Society · 2026
    Pooled it
  2. Review
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors at 9 institutions in 1 country.

Mengtao LiDepartment 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, Beijing, China.
Zhi-Cheng JingKey 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, Beijing, China.
Yang Li2nd Affiliated Hospital of Harbin Medical University, Harbin, China.
Yong Huo1st Affiliated Hospital of Peking University, Beijing, China.
Zaixin YuXiangya Hospital Central-South University, Changsha, Hunan, China.
Gangcheng ZhangWuhan Asia Heart Hospital, Wuhan, Hubei, China.
Ping Zhu1st Affiliated Hospital of the Fourth Military Medical University, Xi'an, Shaanxi, China.
Jinming LiuShanghai Pulmonary Hospital, Tongji University, Shanghai, China.
Qiushang JiQilu Hospital, Shandong University, Jinan, Shandong, China.
Bingxiang Wu2nd Affiliated Hospital of Harbin Medical University, Harbin, China.
Jinhua ZhongGlaxoSmithKline (China) R&D Company Limited, Shanghai, China.
Pingping WangGlaxoSmithKline (China) R&D Company Limited, Shanghai, China.
Wenjing ZhuGlaxoSmithKline (China) R&D Company Limited, Shanghai, China.
Xiaofeng ZengDepartment 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, Beijing, China. xiaofeng.zeng@cstar.org.cn.ORCID 0000-0002-3883-2318
Chinese Academy of Medical Sciences & Peking Union Medical College · CNGlaxoSmithKline (China) · CNHarbin Medical University · CNAir Force Medical University · CNCentral South University · CNPeking University · CNQilu Hospital of Shandong University · CNTongji University · CNWuhan University · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe 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.

methodsIn 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).

resultsIn 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.

conclusionAmbrisentan 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 registrationClinicalTrial.gov Identifier, https://clinicaltrials.gov/, NCT01808313 Registration date (first time): February 28, 2013.

Indexed as

AdultAntihypertensive AgentsBeijingBiomarkersConnective Tissue DiseasesEndothelin A Receptor AntagonistsExercise ToleranceFemaleHumansMaleMiddle AgedNatriuretic Peptide, BrainPeptide FragmentsPhenylpropionatesPulmonary Arterial HypertensionPyridazinesambrisentanAntihypertensive AgentsBiomarkersEndothelin A Receptor AntagonistsNatriuretic Peptide, BrainPeptide FragmentsPhenylpropionatespro-brain natriuretic peptide (1-76)PyridazinesAmbrisentanChineseExercise capacity

Identifiers

PMID32680480
PMCPMC7367256
OpenAlexW3042925286

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.