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Incident and prevalent cohorts with pulmonary arterial hypertension: insight from SERAPHIN
G. Simonneau, RN. Channick, M. Delcroix, N. Galiè, HA. Ghofrani, P. Jansa, FO. Le Brun, S. Mehta, L. Perchenet, T. Pulido, BK. Sastry, O. Sitbon, R. Souza, A. Torbicki, LJ. Rubin,
Language English Country England, Great Britain
Document type Clinical Trial, Phase III, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't
NLK
Free Medical Journals
from 1994 to 18 months ago
Open Access Digital Library
from 1988-01-01
- MeSH
- Endothelin Receptor Antagonists therapeutic use MeSH
- Adult MeSH
- Double-Blind Method MeSH
- Familial Primary Pulmonary Hypertension drug therapy mortality MeSH
- Hospitalization MeSH
- Incidence MeSH
- Kaplan-Meier Estimate MeSH
- Cohort Studies MeSH
- Middle Aged MeSH
- Humans MeSH
- Hypertension, Pulmonary drug therapy mortality MeSH
- Prevalence MeSH
- Disease Progression MeSH
- Proportional Hazards Models MeSH
- Pyrimidines therapeutic use MeSH
- Aged MeSH
- Sulfonamides therapeutic use MeSH
- Treatment Outcome MeSH
- Check Tag
- Adult MeSH
- Middle Aged MeSH
- Humans MeSH
- Male MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Clinical Trial, Phase III MeSH
- Research Support, Non-U.S. Gov't MeSH
- Randomized Controlled Trial MeSH
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.
Actelion Pharmaceuticals Ltd Allschwil Switzerland
Cardiopulmonary Department Ignacio Chávez National Heart Institute Mexico City Mexico
Department of Cardiology CARE Hospitals Hyderabad India
Department of Pneumology Gasthuisberg University Hospital Leuven Belgium
Pulmonary and Critical Care Massachusetts General Hospital Boston MA USA
Pulmonary Department Heart Institute University of São Paulo Medical School São Paulo Brazil
References provided by Crossref.org
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