0
Original Research |

Macitentan improves health-related quality of life for patients with pulmonary arterial hypertension: results from the randomized controlled SERAPHIN trial OPEN ACCESS

S. Mehta, MD; B.K.S. Sastry, MD; R. Souza, MD; A. Torbicki, MD; H.-A. Ghofrani, MD; R.N. Channick, MD; M. Delcroix, MD; T. Pulido, MD; G. Simonneau, MD; J. Wlodarczyk, Ph.D; L.J. Rubin, MD; P. Jansa, MD; E. Hunsche, Ph.D; N. Galiè, MD; L. Perchenet, Ph.D; O. Sitbon, MD
Author and Funding Information

Financial/non-financial disclosures: Sanjay Mehta has received institutional support for participation in pharmaceutical clinical trials from Actelion, Bayer, Gilead, Ikaria, and United Therapeutics, and consulting and speaking fees from Actelion, Bayer, and Pfizer. BKS Sastry has received grants from Actelion Pharmaceuticals Ltd and Pfizer. Rogério Souza has received lecture and advisory fees from Actelion Pharmaceuticals Ltd, Bayer HealthCare, GlaxoSmithKline, and Bristol-Meyers Squibb. Adam Torbicki has received speaker fees from Actelion Pharmaceuticals Ltd, Bayer, GlaxoSmithKline, Sanofi, and AOP; and consultancy and investigator honoraria from Actelion Pharmaceuticals Ltd, Bayer HealthCare, and United Therapeutics. Hossein-Ardeschir Ghofrani has financial relationships with Actelion Pharmaceuticals Ltd, Bayer HealthCare Ergonex, Pfizer, GlaxoSmithKline, Novartis, Gilead, and Merck & Co. Richard Channick has consulted for Actelion Pharmaceuticals Ltd and Bayer HealthCare and has received a research grant from Bayer HealthCare. Marion Delcroix has received grants from Actelion Pharmaceuticals Ltd, GlaxoSmithKline, and Pfizer; has received speaker fees from Actelion Pharmaceuticals Ltd, Bayer HealthCare, and GlaxoSmithKline; and has consulted for Actelion Pharmaceuticals Ltd, GlaxoSmithKline, Pfizer, and Bayer HealthCare. Tomas Pulido has served on advisory boards of Actelion Pharmaceuticals Ltd, Bayer HealthCare, and GlaxoSmithKline, has received grant support through institutional funds from Actelion Pharmaceuticals Ltd, Bayer HealthCare, BristolMyersSquibb, United Therapeutics, GlaxoSmithKline, and Eli Lilly & Company; and has received consultancy honoraria from Actelion Pharmaceuticals Ltd, GlaxoSmithKline and Bayer HealthCare. Gérald Simonneau consults for and has received grants from Actelion Pharmaceuticals Ltd, Bayer, GlaxoSmithKline, and Pfizer. John Wlodarczyk is principal of a consulting firm that has been contracted by Actelion. Lewis J Rubin has consulted for Actelion Pharmaceuticals Ltd, United Therapeutics, Lung LLC, GeNO, Arena Pharmaceuticals, and Gilead. Pavel Jansa has received fees and grants from Actelion Pharmaceuticals Ltd during the conduct of this study and from United Therapeutics, AOP Orphan, Bayer HealthCare, and GlaxoSmithKline. Elke Hunsche is a full-time employee and holds stock/stock options in Actelion. Nazzareno Galiè has financial relationships with Actelion Pharmaceuticals Ltd, Bayer HealthCare, Pfizer, and GlaxoSmithKline. Loïc Perchenet is a full-time employee and holds stock/stock options in Actelion. Olivier Sitbon has consulted for Actelion Pharmaceuticals Ltd, Bayer HealthCare, GlaxoSmithKline, Pfizer and United Therapeutics, and received grants from Actelion Pharmaceuticals Ltd, Bayer HealthCare, GlaxoSmithKline and Pfizer.

Funding information: SERAPHIN was funded by Actelion Pharmaceuticals Ltd.

Notation of prior abstract publication/presentation: Poster presentation at ATS 2013 (Mehta S, et al. Am J Respir Crit Care Med 187;2013:A3269)

Trial Registration ClinicalTrials.gov; No.: NCT00660179; URL clinicaltrials.gov.

1London Health Sciences Centre, Victoria Hospital, Western University, London, Ontario, Canada

2CARE Hospitals, Hyderabad, India

3Heart Institute, University of São Paulo Medical School, São Paulo, Brazil

4Centre of Postgraduate Medical Education, ECZ- Otwock, Poland

5University of Giessen and Marburg Lung Center (UGMLC), Giessen, Germany; Member of the German Center of Lung Research (DZL), Giessen, Germany, and Department of Medicine, Imperial College London, London, UK

6Massachusetts General Hospital, Boston, Massachusetts, USA

7Gasthuisberg University Hospital, Leuven, Belgium

8Ignacio Chávez National Heart Institute, Mexico City, Mexico

9Assistance 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

10John Wlodarczyk Consulting Services, Newcastle, Australia

11University of California, San Diego Medical School, San Diego, California, USA

12Charles University, Prague, Czech Republic

13Actelion Pharmaceuticals Ltd, Allschwil, Switzerland

14Bologna University Hospital, Bologna, Italy

Corresponding author: Sanjay Mehta London Health Sciences Centre, Victoria Hospital, Western University, London, Ontario, Canada.


Copyright 2016, . All Rights Reserved.


Chest. 2016. doi:10.1016/j.chest.2016.08.1473
Text Size: A A A
Published online

Abstract

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 PAH patients in the 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 completed the SF-36 questionnaire at baseline, Month 6, Month 12 and 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 SF-36 physical and mental component summary (PCS and MCS) scores and associations between baseline PCS/MCS scores and time to morbidity/mortality event were also assessed.

Results  At Month 6, macitentan 10 mg significantly improved 7 of 8 SF-36 domains, and the PCS and MCS scores, versus placebo. Macitentan 10 mg significantly reduced the risk of a ≥3-point deterioration in PCS (HR 0.60, 95% CL 0.47-0.76, P<0.0001) and MCS scores (HR 0.76, 95% CL 0.61-0.95, P=0.0173) up to EOT versus placebo. Patients with a baseline PCS score above the median baseline value had a significantly reduced risk of morbidity/mortality compared with patients with a PCS score below the median; a similar result was observed for the MCS score.

Conclusions  Macitentan significantly improved HRQoL in PAH patients 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.


This article is only available in the PDF format. Download the PDF

Figures

Tables

References

NOTE:
Citing articles are presented as examples only. In non-demo SCM6 implementation, integration with CrossRef’s "Cited By" API will populate this tab (http://www.crossref.org/citedby.html).

Some tools below are only available to our subscribers or users with an online account.

Related Content

Customize your page view by dragging & repositioning the boxes below.

Find Similar Articles
CHEST Journal Articles
  • CHEST Journal
    Print ISSN: 0012-3692
    Online ISSN: 1931-3543