Evidence map›Paper›PMID 26493786›Full record

Trial reportThe European respiratory journal2015

Incident and prevalent cohorts with pulmonary arterial hypertension: insight from SERAPHIN.

Gérald Simonneau, Richard N Channick, Marion Delcroix, Nazzareno Galiè, Hossein-Ardeschir Ghofrani, Pavel Jansa, Franck-Olivier Le Brun, Sanjay Mehta, Loic Perchenet, Tomás Pulido and 5 more

Registry-linked trialAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in The European respiratory journal, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00660179 (A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group, Event-driven, Phase III Study to Assess the Effects of Macitentan), which is not on this map. Cited by 18 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed, 2 pooled it
–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.

NCT00660179 phase3completednot on this map

A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group, Event-driven, Phase III Study to Assess the Effects of Macitentan (ACT-064992) on Morbidity and Mortality in Patients With Symptomatic Pulmonary Arterial Hypertension

TypeinterventionalSponsorActelionRan2008 to 2012Enrolled742ConditionsPulmonary Arterial HypertensionArmsmacitentan (ACT-064992), placebo
3 · Its place in the literature

Who cites it

18 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  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. Pooled it
  3. Observational
  4. Observational
  5. Article
  6. Observational
  7. Review
  8. Article
  9. Review
  10. Review
  11. Pulmonary arterial hypertension: tailoring treatment to risk in the current era.European respiratory review : an official journal of the European Respiratory Society · 2017
    Review
  12. Beyond a single pathway: combination therapy in pulmonary arterial hypertension.European respiratory review : an official journal of the European Respiratory Society · 2016
    Review
  13. Risk assessment in pulmonary arterial hypertension.European respiratory review : an official journal of the European Respiratory Society · 2016
    Review
  14. Review
  15. Pulmonary hypertension in India: Need for organized approach.Lung India : official organ of Indian Chest Society
    Article
  16. Review
  17. Article
  18. 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

15 authors.

Gérald SimonneauAssistance Publique-Hôpitaux de Paris, Service de Pneumologie, Hôpital Bicêtre, Le Kremlin-Bicêtre, France Université Paris-Sud, Laboratoire d'Excellence en Recherche sur le Médicament et Innovation Thérapeutique, Le Kremlin-Bicêtre, France INSERM U-999, Centre chirurgical Marie Lannelongue, Le Plessis Robinson, France gerald.simonneau@bct.aphp.fr.
Richard N ChannickPulmonary and Critical Care, Massachusetts General Hospital, Boston, MA, USA.
Marion DelcroixDepartment of Pneumology, Gasthuisberg University Hospital, Leuven, Belgium.
Nazzareno GalièDepartment of Experimental, Diagnostic and Specialty Medicine (DIMES), Bologna University Hospital, Bologna, Italy.
Hossein-Ardeschir GhofraniUniversity of Giessen and Marburg Lung Center, Giessen, Germany Member of the German Center of Lung Research (DZL), Giessen, Germany Department of Medicine, Imperial College London, London, UK.
Pavel JansaClinical Department of Cardiology and Angiology, 1st Faculty of Medicine, 2nd Medical Department, Charles University, Prague, Czech Republic.
Franck-Olivier Le BrunActelion Pharmaceuticals Ltd, Allschwil, Switzerland.
Sanjay MehtaDivision of Respirology, Department of Medicine, London Health Sciences Centre - Victoria Hospital, Western University, London, ON, Canada.
Loic PerchenetActelion Pharmaceuticals Ltd, Allschwil, Switzerland.
Tomás PulidoCardiopulmonary Department, Ignacio Chávez National Heart Institute, Mexico City, Mexico.
B K S SastryDepartment of Cardiology, CARE Hospitals, Hyderabad, India.
Olivier SitbonAssistance Publique-Hôpitaux de Paris, Service de Pneumologie, Hôpital Bicêtre, Le Kremlin-Bicêtre, France Université Paris-Sud, Laboratoire d'Excellence en Recherche sur le Médicament et Innovation Thérapeutique, Le Kremlin-Bicêtre, France INSERM U-999, Centre chirurgical Marie Lannelongue, Le Plessis Robinson, France.
Rogério SouzaPulmonary Department, Heart Institute, University of São Paulo Medical School, São Paulo, Brazil.
Adam TorbickiDepartment of Pulmonary Circulation and Thromboembolic Diseases, Center of Postgraduate Medical Education, ECZ-Otwock, Otwock, Poland.
Lewis J RubinDivision of Pulmonary and Critical Care Medicine, University of California, San Diego Medical School, San Diego, CA, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

In SERAPHIN, a long-term, randomised, controlled trial (NCT00660179) in pulmonary arterial hypertension (PAH), macitentan significantly reduced the risk of morbidity/mortality and PAH-related death/hospitalisation. We evaluated disease progression and the effect of macitentan in treatment-naïve incident and prevalent cohorts.Patients allocated to placebo, or macitentan 3 mg or 10 mg were classified by time from diagnosis to enrolment as incident (≤6 months; n=110) or prevalent (>6 months; n=157). The risk of morbidity/mortality and PAH-related death/hospitalisation was determined using Cox regression.The risk of morbidity/mortality (Kaplan-Meier estimates at month 12: 54.4% versus 26.7%; p=0.006) and PAH-related death/hospitalisation (Kaplan-Meier estimates at month 12: 47.3% versus 19.9%; p=0.006) were significantly higher for incident versus prevalent patients receiving placebo, respectively. There was no significant difference in the risk of all-cause death between incident and prevalent cohorts (p=0.587). Macitentan 10 mg significantly reduced the risk of morbidity/mortality and PAH-related death/hospitalisation versus placebo in incident and prevalent cohorts.Incident patients had a higher risk for PAH progression compared with prevalent patients but not a higher risk of death. Macitentan delayed disease progression in both incident and prevalent PAH patients.

Indexed as

AdultAgedCohort StudiesDisease ProgressionDouble-Blind MethodEndothelin Receptor AntagonistsFamilial Primary Pulmonary HypertensionFemaleHospitalizationHumansHypertension, PulmonaryIncidenceKaplan-Meier EstimateMaleMiddle AgedPrevalenceEndothelin Receptor AntagonistsmacitentanPyrimidinesSulfonamides

Identifiers

PMID26493786
PMCPMC4664609

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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.