Evidence map›Paper›PMID 41250682›Full record

ArticlePulmonary circulation2025

Macitentan Plus Tadalafil Single-Tablet Combination Therapy in Chinese Patients With Pulmonary Arterial Hypertension: A Subgroup Analysis of the A DUE Study.

Fenling Fan, Luying Sun, Zhenwen Yang, Lan Wang, Qiguang Wang, Jiang Li, Hong Gu, Weiping Xie, Nuofu Zhang, Jia Bin and 3 more

Registry-linked trialAbstract read
In one paragraph

Article in Pulmonary circulation, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03904693 (Prospective, Multi-center, Double-blind, Randomized, Active-controlled, Triple-dummy, Parallel-group, Group-sequential, Adaptive Phase 3 Clinical Study to Compare the Efficacy and Safety of Macitentan and Tadalafil Monotherapies With the Corresponding Fixed Dose Combination in Subjects With Pulmonary Arterial Hypertension), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
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.

NCT03904693 phase3completednot on this map

Prospective, Multi-center, Double-blind, Randomized, Active-controlled, Triple-dummy, Parallel-group, Group-sequential, Adaptive Phase 3 Clinical Study to Compare the Efficacy and Safety of Macitentan and Tadalafil Monotherapies With the Corresponding Fixed Dose Combination in Subjects With Pulmonary Arterial Hypertension (PAH), Followed by an Open-label Treatment Period With Macitentan and Tadalafil Fixed Dose Combination Therapy

TypeinterventionalSponsorActelionRan2019 to 2024Enrolled187ConditionsPulmonary Arterial Hypertension (PAH) (WHO Group 1 PH)ArmsFDC macitentan/tadalafil, Macitentan 10 mg, Tadalafil 40 mg, Placebo FDC, Placebo macitentan
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Review
  2. 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

13 authors.

Fenling FanDepartment of Cardiovascular Medicine First Affiliated Hospital of Xi'an Jiaotong University Xi'an Shanxi China.ORCID https://orcid.org/0000-0002-7732-7701
Luying SunDepartment of Clinical Development Johnson and Johnson (China) Investment Ltd. Shanghai China.
Zhenwen YangDepartment of Cardiovascular Medicine Tianjin Medical University General Hospital Tianjing China.
Lan WangDepartment of Cardiovascular Medicine Shanghai Pulmonary Hospital Shanghai China.
Qiguang WangDepartment of Cardiovascular Medicine General Hospital of Northern Theater Command Shenyang Liaoning China.
Jiang LiDepartment of Cardiovascular Medicine The Second Xiangya Hospital of Central South University Changsha Hunan China.
Hong GuDepartment of Cardiovascular Medicine Beijing Anzhen Hospital, Capital Medical University Beijing China.
Weiping XieDepartment of Respiratory and Critical Care Medicine The First Affiliated Hospital of Nanjing Medical University (Jiangsu Province Hospital) Nanjing Jiangsu China.ORCID https://orcid.org/0000-0002-6011-0143
Nuofu ZhangDepartment of Cardiovascular Medicine The First Affiliated Hospital of Guangzhou Medical University Guangzhou China.ORCID https://orcid.org/0000-0003-1998-9958
Jia BinDepartment of Statistics and Decision Sciences Johnson and Johnson (China) Investment Ltd Shanghai China.
Hany RofaelDepartment of Clinical Science Janssen Research and Development, LLC Titusville New Jersey USA.
Michael FribergDepartment of Clinical Science Actelion Pharmaceuticals Ltd., a Janssen Pharmaceutical Company of Johnson & Johnson Allschwil Switzerland.
Jakob A HauserDepartment of Clinical Science Actelion Pharmaceuticals Ltd., a Janssen Pharmaceutical Company of Johnson & Johnson Allschwil Switzerland.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Macitentan 10 mg and tadalafil 40 mg single-tablet combination therapy (M/T STCT) has been evaluated in the global A DUE study (NCT03904693). Here, we report the results of a subgroup analysis in participants from China. This double-blind, active-controlled, Phase 3 A DUE study randomized patients with symptomatic pulmonary arterial hypertension (PAH) to receive M/T STCT, macitentan, or tadalafil depending on their baseline PAH treatment (treatment-naïve, endothelin receptor antagonist, or phosphodiesterase Type 5 inhibitor monotherapy). The primary end point was change in pulmonary vascular resistance (PVR) expressed as the ratio of geometric means (GMR) of Week 16 to baseline. A total of 187 patients were randomized, including 23 patients in China. PVR reduction was significantly greater with M/T STCT compared with macitentan (50%) and tadalafil (41%) (adjusted GMRs were 0.50; 95% confidence level [CL]: 0.35-0.72;

Indexed as

macitentanpulmonary arterial hypertensionsingle‐tablet combination therapytadalafil

Identifiers

PMID41250682
PMCPMC12619956

What Socratic 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 Socratic graph.