Evidence map›Paper›PMID 36381290›Full record

ArticlePulmonary circulation2022

Safety of macitentan for the treatment of pulmonary hypertension: Real-world experience from the OPsumit® USers Registry (OPUS) and OPsumit® Historical USers cohort (OrPHeUS).

Vallerie V McLaughlin, Richard Channick, Nick H Kim, Robert P Frantz, John W McConnell, Lana Melendres-Groves, Chad Miller, Ashwin Ravichandran, Josanna Rodriguez-Lopez, Monika Brand and 3 more

Open access · goldAbstract read
In one paragraph

Article in Pulmonary circulation, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed
3.0field-weighted citation impact, top 7% 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.

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

18 citing papers in PubMed, 20 citations in OpenAlex.

  1. Observational
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  5. Observational
  6. Observational
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  8. Article
  9. Pulmonary arterial hypertension in Latin America. The age and comorbidity paradox.International journal of cardiology. Congenital heart disease · 2025
    Review
  10. Article
  11. Article
  12. Article
  13. Observational
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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 at 11 institutions in 2 countries.

Vallerie V McLaughlinDepartment of Internal Medicine, Division of Cardiovascular Medicine University of Michigan Ann Arbor Michigan USA.ORCID 0000-0002-8907-1651
Richard ChannickPulmonary and Critical Care Division, David Geffen School of Medicine University of California Los Angeles Los Angeles California USA.
Nick H KimDivision of Pulmonary, Critical Care and Sleep Medicine University of California San Diego La Jolla California USA.ORCID 0000-0003-4702-650X
Robert P FrantzDepartment of Cardiovascular Medicine Mayo Clinic Rochester Minnesota USA.ORCID 0000-0003-4128-3978
John W McConnellNorton Healthcare, Norton Pulmonary Specialists Louisville Kentucky USA.
Lana Melendres-GrovesDivision of Pulmonary, Critical Care and Sleep Medicine, Department of Internal Medicine University of New Mexico Albuquerque New Mexico USA.
Chad MillerPulmonary Hypertension and Pulmonary Critical Care Medicine, Piedmont Physicians, Piedmont Healthcare Austell Georgia USA.
Ashwin RavichandranSt Vincent Heart Center Indianapolis Indiana USA.
Josanna Rodriguez-LopezDivision of Pulmonary and Critical Care Medicine Massachusetts General Hospital Boston Massachusetts USA.
Monika BrandActelion Pharmaceuticals Ltd, a Janssen Pharmaceutical Company of Johnson and Johnson, Global Epidemiology Allschwil Switzerland.
Sandrine LeroyActelion Pharmaceuticals Ltd, a Janssen Pharmaceutical Company of Johnson and Johnson, Data Science Global Regulatory Affairs Allschwil Switzerland.
Graham WetherillActelion Pharmaceuticals Ltd, a Janssen Pharmaceutical Company of Johnson and Johnson, Medical Affairs and Established Products Allschwil Switzerland.
Kelly M ChinDepartment of Internal Medicine UT Southwestern Medical Center Dallas Texas USA.
Johnson & Johnson (Switzerland) · CHMassachusetts General Hospital · USMayo Clinic · USMichigan Medicine · USNorton Healthcare · USPiedmont HealthCare · USSouthwestern Medical Center · USSt Vincent Hospital · USUniversity of California, Los Angeles · USUniversity of California System · USUniversity of New Mexico · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Macitentan is an oral endothelin receptor antagonist for the management of pulmonary arterial hypertension (PAH). The OPsumit® USers Registry (OPUS) and the OPsumit® Historical USers cohort (OrPHeUS) medical chart review provide real-world data for patients newly initiating macitentan. This study aims to describe the characteristics, safety profile, and clinical outcomes of PAH patients newly treated with macitentan in the combined OPUS/OrPHeUS data set. OPUS was a prospective, multicenter, long-term, observational drug registry from April 2014 to June 2020. OrPHeUS was a retrospective, US, multicenter chart review: observation period October 2013 to March 2017. All analyses were descriptive. At registry closure in June 2020, the combined population consisted of 5654 patients, of whom 81.9% were diagnosed with PAH. For these 4626 patients, median duration of macitentan exposure observed was 14.5 (Q1 = 5.2, Q3 = 29.0) months; idiopathic PAH (54.8%) was the most common form of PAH; macitentan was initiated as monotherapy (37.9%), or as part of double (48.0%) or triple therapy (14.1%); discontinuation due to nonhepatic/hepatic adverse events occurred in 17.1%/0.3% of patients; 9.9% of patients experienced ≥1 hepatic adverse events; Kaplan-Meier estimates showed that at 1 year 59.9% (95% confidence interval: 58.3, 61.5) of patients were free from hospitalization and survival was 90.4% (89.3, 91.3). This analysis of real-world data from the combined OPUS and OrPHeUS populations demonstrated that macitentan is well tolerated in a large, diverse population of PAH patients, with overall and hepatic safety profiles consistent with previous macitentan clinical trials.

Indexed as

cardiopulmonary diseaseepidemiologyhepatic safetypulmonary arterial hypertensionreal‐world evidence

Identifiers

PMID36381290
PMCPMC9661363
OpenAlexW4307047407

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

None linked

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.