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

Simonneau G, Channick RN, Delcroix M, Galiè N, Ghofrani HA, Jansa P, Le Brun FO, Mehta S, Perchenet L, Pulido T, Sastry BK, Sitbon O, Souza R, Torbicki A, Rubin LJ - Eur. Respir. J. (2015)

Bottom Line: 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.

View Article: PubMed Central - PubMed

Affiliation: Assistance 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.

No MeSH data available.


Related in: MedlinePlus

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.
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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.

Mentions: The effect of macitentan 10 mg on the composite end-point of morbidity and mortality in the incident and prevalent cohorts versus placebo is shown in figure 1. Treatment with macitentan 10 mg significantly reduced the risk of a morbidity or mortality event versus placebo by 60% in incident patients (HR 0.40, 95% CI 0.20–0.79; log-rank p=0.007) and by 53% in prevalent patients (HR 0.47, 95% CI 0.24–0.92; log-rank p=0.023) (figure 2). The test for interaction was nonsignificant (p=0.602), indicating no heterogeneity of the treatment effect across the incident and prevalent cohorts. The magnitude of the treatment effect observed in the macitentan 3 mg group (versus placebo) was smaller than that of the macitentan 10 mg group (figure S1).FIGURE 1


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

Simonneau G, Channick RN, Delcroix M, Galiè N, Ghofrani HA, Jansa P, Le Brun FO, Mehta S, Perchenet L, Pulido T, Sastry BK, Sitbon O, Souza R, Torbicki A, Rubin LJ - Eur. Respir. J. (2015)

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.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4664609&req=5

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.
Mentions: The effect of macitentan 10 mg on the composite end-point of morbidity and mortality in the incident and prevalent cohorts versus placebo is shown in figure 1. Treatment with macitentan 10 mg significantly reduced the risk of a morbidity or mortality event versus placebo by 60% in incident patients (HR 0.40, 95% CI 0.20–0.79; log-rank p=0.007) and by 53% in prevalent patients (HR 0.47, 95% CI 0.24–0.92; log-rank p=0.023) (figure 2). The test for interaction was nonsignificant (p=0.602), indicating no heterogeneity of the treatment effect across the incident and prevalent cohorts. The magnitude of the treatment effect observed in the macitentan 3 mg group (versus placebo) was smaller than that of the macitentan 10 mg group (figure S1).FIGURE 1

Bottom Line: 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.

View Article: PubMed Central - PubMed

Affiliation: Assistance 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.

No MeSH data available.


Related in: MedlinePlus