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Clinical Trial
. 2015 Dec;46(6):1711-20.
doi: 10.1183/13993003.00364-2015. Epub 2015 Oct 22.

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

Gérald Simonneau  1 , Richard N Channick  2 , Marion Delcroix  3 , Nazzareno Galiè  4 , Hossein-Ardeschir Ghofrani  5 , Pavel Jansa  6 , Franck-Olivier Le Brun  7 , Sanjay Mehta  8 , Loic Perchenet  7 , Tomás Pulido  9 , B K S Sastry  10 , Olivier Sitbon  11 , Rogério Souza  12 , Adam Torbicki  13 , Lewis J Rubin  14
Affiliations
Clinical Trial

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

Gérald Simonneau et al. Eur Respir J. 2015 Dec.

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.

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Conflict of interest statement

Conflict of interest: Disclosures can be found alongside the online version of this article at erj.ersjournals.com

Figures

FIGURE 1
FIGURE 1
Effect of macitentan 10 mg on morbidity and mortality in treatment-naïve incident and prevalent cohorts.
FIGURE 2
FIGURE 2
Forest plot of risk of time to event end-points in treatment-naïve incident and prevalent cohorts of patients with pulmonary arterial hypertension (PAH) treated with macitentan 10 mg versus placebo. EOT: end of treatment; EOS: end of study.
FIGURE 3
FIGURE 3
Effect of macitentan 10 mg on pulmonary arterial hypertension-related death or hospitalisation in treatment-naïve incident and prevalent cohorts.
FIGURE 4
FIGURE 4
Effect of macitentan 10 mg on all-cause mortality up to end of study in treatment-naïve incident and prevalent cohorts.
See this image and copyright information in PMC

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