BACKGROUND: Pulmonary arterial hypertension (PAH) leads to reduced health-related quality of life (HRQoL). The objectives of this analysis were to evaluate the effect of macitentan on HRQoL in patients with PAH in the Study with an Endothelin Receptor Antagonist in Pulmonary Arterial Hypertension to Improve Clinical Outcome (SERAPHIN) study. The association between baseline HRQoL and long-term outcomes was also investigated. METHODS: Patients were randomized to placebo, macitentan 3 mg, or macitentan 10 mg once daily. Patients aged 14 years or older completed the 36-Item Short Form Survey (SF-36) at baseline, at month 6 and month 12, and at the end of treatment (EOT). The absolute change from baseline to month 6 in SF-36 scores was calculated. The time to a clinically meaningful deterioration in the SF-36 physical component summary and mental component summary (PCS and MCS) scores and associations between baseline PCS/MCS scores and time to morbidity/mortality events were also assessed. RESULTS: At month 6, macitentan 10 mg significantly improved seven of eight SF-36 domains and the PCS and MCS scores vs placebo. Macitentan 10 mg significantly reduced the risk of a three-point or greater deterioration in PCS (hazard ratio [HR], 0.60; 95% CI, 0.47-0.76; P < .0001) and MCS scores (HR, 0.76; 95% CI, 0.61-0.95; P = .0173) until EOT vs placebo. Patients with a baseline PCS score greater than the median baseline value had a significantly reduced risk of morbidity/mortality compared with patients with a PCS score less than the median; a similar result was observed for the MCS score. CONCLUSIONS: Macitentan significantly improved HRQoL in patients with PAH compared with placebo and significantly reduced the risk of a clinically meaningful HRQoL deterioration. An association between better baseline HRQoL and improved long-term outcomes was shown. TRIAL REGISTRY: ClinicalTrials.gov; No.: NCT00660179; URL: clinicaltrials.gov.

Actelion Pharmaceuticals Ltd Allschwil Switzerland

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 and INSERM U 999 Centre chirurgical Marie Lannelongue Le Plessis Robinson France

Bologna University Hospital Bologna Italy

CARE Hospitals Hyderabad India

Centre of Postgraduate Medical Education Europejskie Centrum Zdrowia Otwock Poland

Charles University Prague Czech Republic

Gasthuisberg University Hospital Leuven Belgium

Heart Institute University of São Paulo Medical School São Paulo Brazil

Ignacio Chávez National Heart Institute Mexico City Mexico

John Wlodarczyk Consulting Services Newcastle Australia

London Health Sciences Centre Victoria Hospital Western University London ON Canada

Massachusetts General Hospital Boston MA

University of California San Diego Medical School San Diego CA

University of Giessen and Marburg Lung Center Giessen Germany Member of the German Center of Lung Research Giessen Germany and Department of Medicine Imperial College London London England

Chest. 2018 May;153(5):1287. doi: 10.1016/j.chest.2018.03.030. PubMed

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Macitentan in Pulmonary Arterial Hypertension: A Focus on Combination Therapy in the SERAPHIN Trial

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ClinicalTrials.gov
NCT00660179