Simonneau Gérald, Channick Richard N, Delcroix Marion, Galiè Nazzareno, Ghofrani Hossein-Ardeschir, Jansa Pavel, Le Brun Franck-Olivier, Mehta Sanjay, Perchenet Loic, Pulido Tomás, Sastry B K S, Sitbon Olivier, Souza Rogério, Torbicki Adam, Rubin Lewis J
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
Pulmonary and Critical Care, Massachusetts General Hospital, Boston, MA, USA.
Eur Respir J. 2015 Dec;46(6):1711-20. doi: 10.1183/13993003.00364-2015. Epub 2015 Oct 22.
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.
在SERAPHIN研究中，这是一项针对肺动脉高压（PAH）的长期、随机、对照试验（NCT00660179），马昔腾坦显著降低了发病/死亡风险以及PAH相关死亡/住院风险。我们评估了疾病进展情况以及马昔腾坦在初治新发和现患队列中的疗效。分配至安慰剂组、3毫克或10毫克马昔腾坦组的患者，根据从诊断到入组的时间分为新发（≤6个月；n = 110）或现患（>6个月；n = 157）。使用Cox回归确定发病/死亡风险以及PAH相关死亡/住院风险。接受安慰剂的新发患者与现患患者相比，发病/死亡风险（12个月时的Kaplan-Meier估计值：54.4%对26.7%；p = 0.006）以及PAH相关死亡/住院风险（12个月时的Kaplan-Meier估计值：47.3%对19.9%；p = 0.006）分别显著更高。新发队列和现患队列之间的全因死亡风险无显著差异（p = 0.587）。在新发和现患队列中，10毫克马昔腾坦与安慰剂相比，显著降低了发病/死亡风险以及PAH相关死亡/住院风险。与现患患者相比，新发患者的PAH进展风险更高，但死亡风险并不更高。马昔腾坦延缓了新发和现患PAH患者的疾病进展。
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