Evidence map›Paper›PMID 40100308›Full record

ArticleAdvances in therapy2025

Single-Tablet Combination Therapy of Macitentan/Tadalafil for Patients with Pulmonary Arterial Hypertension: Qualitative Interview Study of the A DUE Phase 3 Trial.

Fenling Fan, Stacy Davis, Claire Burbridge, Kelly Chin, Michael Friberg, Ekkehard Grünig, Melanie Hughes, Pavel Jansa, Jörg Linder, Jennifer Rafalski and 2 more

Abstract read
In one paragraph

Article in Advances in therapy, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

5 citing papers in PubMed.

  1. Trial
  2. Article
  3. Review
  4. Article
  5. 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

12 authors.

Fenling FanFirst Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi, China.ORCID http://orcid.org/0000-0002-7732-7701
Stacy DavisJanssen Global Services, LLC, a Johnson & Johnson Company, Horsham, PA, USA.ORCID http://orcid.org/0000-0003-4201-0891
Claire BurbridgeClinical Outcomes Solutions, Folkestone, UK.ORCID http://orcid.org/0000-0003-0117-7169
Kelly ChinUT Southwestern Medical Center, Dallas, TX, USA.ORCID http://orcid.org/0000-0002-1214-6723
Michael FribergJanssen-Cilag Limited, a Johnson & Johnson Company, Clinical Science, Glasgow, UK.
Ekkehard GrünigThoraxklinik at Heidelberg University Hospital, Heidelberg, Germany.ORCID http://orcid.org/0000-0001-7318-3918
Melanie HughesClinical Outcomes Solutions, Folkestone, UK.
Pavel JansaCharles University and General University Hospital, Prague, Czech Republic.ORCID http://orcid.org/0000-0002-3711-7064
Jörg LinderJanssen-Cilag GmbH, a Johnson & Johnson Company, Neuss, Germany.ORCID http://orcid.org/0000-0003-1119-160X
Jennifer RafalskiClinical Outcomes Solutions, Chicago, IL, USA.
Alvaro Agustin RodriguezJanssen Research and Development, LLC, a Johnson & Johnson Company, Titusville, NJ, USA.
Jason A RandallClinical Outcomes Solutions, Folkestone, UK. jason.randall@clinoutsolutions.com.ORCID http://orcid.org/0000-0001-9229-7013

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionThis study explored patient and clinician perspectives on a new fixed-dose combination of macitentan and tadalafil (M/T FDC) in a once-daily single tablet for treatment of pulmonary arterial hypertension (PAH).

methodsQualitative semi-structured interviews were conducted during the open-label period of the global, phase 3 A DUE clinical trial that evaluated M/T FDC. A subset of enrolled patients (N = 26) and site investigators (N = 18 clinicians) were interviewed. Patients received four tablets during double-blind treatment and could be in one of three arms (macitentan + placebo; tadalafil + placebo; M/T FDC + placebo) followed by M/T FDC (one tablet) during the open-label period. Patients and clinicians were asked to share their experience of pre-trial PAH medication, double-blind treatment, and open-label M/T FDC. Thematic analysis was conducted on blinded data.

resultsPatients preferred the M/T FDC tablet (open-label) over the four tablets during double-blind treatment. Patients were satisfied with M/T FDC, highlighting its positive impact on their psychological well-being, through reducing stress associated with managing multiple pills. All patients indicated that having a single, once-a-day pill for PAH was more convenient and associated with greater treatment adherence. Clinicians highlighted that their patients have a high daily pill burden for PAH and other comorbidities, and prefer treatments with an oral mode of administration that reduce the number of daily pills required. Clinicians felt that M/T FDC would be well received in clinical practice and potentially assist in implementing guideline-recommended combination treatment of PAH.

conclusionsIn this qualitative analysis, all 26 patients and 18 clinicians provided positive feedback on M/T FDC treatment, which was consistent across countries. Reducing the number of pills needed to treat PAH, through use of single-tablet M/T FDC, is highly valued by patients and endorsed by clinicians, who both felt the single-tablet combination therapy could have a positive effect on patients' well-being and increase treatment adherence.

Indexed as

Antihypertensive AgentsHypertension, PulmonaryPulmonary Arterial HypertensionPyrimidinesSulfonamidesTadalafilAdaptive Clinical Trials as TopicAdultAgedClinical Trials, Phase III as TopicDouble-Blind MethodDrug CombinationsFemaleHumansInterviews as TopicMaleAntihypertensive AgentsDrug Combinationsmacitentanmacitentan-tadalafilPhosphodiesterase 5 InhibitorsPyrimidinesSulfonamidesTabletsTadalafilClinician interviewFixed-dose combinationPatient interviewPatient perspectivePolypharmacyPulmonary arterial hypertensionTreatment adherence

Identifiers

PMID40100308
PMCPMC12006254

What OpenQuestion holds

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Registered trials

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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.