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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
Macitentan for the treatment of idiopathic pulmonary fibrosis: The randomised controlled MUSIC trial
European Respiratory Journal, Volume 42, No. 6, Year 2013
Notification
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Description
Idiopathic pulmonary fibrosis is a progressive, fatal disease. This prospective, randomised, double-blind, multicentre, parallel-group, placebo-controlled phase II trial (NCT00903331) investigated the efficacy and safety of the endothelin receptor antagonist macitentan in idiopathic pulmonary fibrosis. Eligible subjects were adults with idiopathic pulmonary fibrosis of <3 years duration and a histological pattern of usual interstitial pneumonia on surgical lung biopsy. The primary objective was to demonstrate that macitentan (10 mg once daily) positively affected forced vital capacity versus placebo. Using a centralised system, 178 subjects were randomised (2:1) to macitentan (n=119) or placebo (n=59). The median change from baseline up to month 12 in forced vital capacity was -0.20 L in the macitentan arm and -0.20 L in the placebo arm. Overall, no differences between treatments were observed in pulmonary function tests or time to disease worsening or death. Median exposures to macitentan and placebo were 14.5 months and 15.0 months, respectively. Alanine and/or aspartate aminotransferase elevations over three times upper limit of normal arose in 3.4% of macitentan-treated subjects and 5.1% of placebo recipients. In conclusion, the primary objective was not met. Long-term exposure to macitentan was well tolerated with a similar, low incidence of elevated hepatic aminotransferases in each treatment group. Copyright © ERS 2013.
Authors & Co-Authors
Raghu, Ganesh R.
United States, Seattle
University of Washington
Million-Rousseau, Rachel
Switzerland, Allschwil
Actelion Pharmaceuticals Ltd.
Morganti, Adele
Switzerland, Allschwil
Actelion Pharmaceuticals Ltd.
Perchenet, Loïc
Switzerland, Allschwil
Actelion Pharmaceuticals Ltd.
Behr, Juergen
Germany, Munich
Ludwig-maximilians-universität München
Goh, N.
Australia, Melbourne
The Alfred
Glanville, A.
Australia, Sydney
St. Vincent's Hospital Sydney
Musk, M.
Australia, Perth
Royal Perth Hospital
Hopkins, P.
Australia
Prince Charles Hospital Lung Transplant
Lien, D. C.
Canada, Edmonton
University of Alberta
Chan, Charles K.N.
Canada, Toronto
University Health Network
Rolf, J. D.
Canada, Kelowna
Kelowna General Hospital
Wilcox, P.
Canada, Vancouver
St. Paul's Hospital, Vancouver
Cox, Gérard P.
Canada, Hamilton
St. Joseph's Healthcare Hamilton
Manganas, H.
Canada, Montreal
Hôpital Notre-dame
Cottin, Vincent
France, Lille
Chu Lille
Valeyre, Dominique
France, Bobigny
Hopital Avicenne
Walleart, B.
France, Lille
Chu Lille
Andreas, S.
Germany, Immenhausen
Fachklinik Für Lungenerkrankungen
Neurohr, C.
Germany, Munich
Klinikum Der Universität München
Guenther, Andreas
Germany, Giessen
Justus-liebig-universität Gießen
Schönfeld, Nicolas
Germany, Berlin
Helios Klinikum Emil Von Behring
Koch, A.
Germany, Koln
Uniklinik Köln
Kramer, M.
Israel, Petah Tiqwa
Rabin Medical Center Israel
Breuer, R.
Israel, Jerusalem
Hadassah University Medical Centre
Ben-Dov, I.
Israel, Tel Hashomer Tel Aviv
Chaim Sheba Medical Center Israel
Fink, Gershon
Israel, Rehovot
Kaplan Medical Center
Schwarz, Y.
Israel, Tel Aviv-yafo
Tel Aviv Sourasky Medical Center
Albera, C.
Italy, Torino
Azienda Ospedaliera
Confalonieri, Marco
Italy, Trieste
Ospedale Di Cattinara
Saltini, Cesare
Italy, Rome
Policlinico Tor Vergata
Harari, Sergio Alfonso
Italy, Milan
Ospedale San Giuseppe, Milano
Flezar, M.
Slovenia, Golnik
Bolnišnica Golnik
Greenblatt, Michael M.
South Africa, Johannesburg
Milpark Hospital
Ras, G. J.
South Africa, Johannesburg
Milpark Hospital
Morell, F.
Spain, Barcelona
Hospital Univeristari Vall D'hebrón
Alvarez-Sala, J. L.
Spain, Madrid
Hospital Clínico San Carlos
Xaubet, A.
Spain, Barcelona
Hospital Clinic Barcelona
Sueiro, A.
Spain, Madrid
Hospital Universitario Ramón y Cajal
Linares, M. J.
Spain, Alcorcon
Hospital Universitario Fundación Alcorcón
Sköld, Carl Magnus
Sweden, Stockholm
Karolinska Universitetssjukhuset
Kayacan, O.
Turkey, Ankara
Ankara Üniversitesi
Mogulkoc, N.
Turkey, Izmir
Ege University Medical School
Chan, A.
United States, Sacramento
Uc Davis Medical Center
Chapman, J.
United States, Cleveland
Cleveland Clinic Foundation
Parambil, J.
United States, Cleveland
Cleveland Clinic Foundation
Ettinger, N.
United States, Chesterfield
Cardio Pulmonary Associates
Golden, J.
United States, San Francisco
University of California, San Francisco
Meyer, K. C.
United States, Madison
Uw Health
Swigris, J. J.
United States, Denver
National Jewish Health
Yung, G. L.
United States, La Jolla
University of California, San Diego
Antin-Ozerkis, D.
United States, New Haven
Yale School of Medicine
Mohabir, Paul K.
United States, Stanford
Stanford Healthcare
Wesselius, L. J.
United States, Scottsdale
Mayo Clinic Scottsdale-phoenix, Arizona
De Andrade, J.
United States, Birmingham
The University of Alabama at Birmingham
Cordova, F.
United States, Philadelphia
Temple Health
Safdar, Z.
United States, Houston
Baylor College of Medicine
Wencel, M.
United States, Wichita
Wichita Clinic
Statistics
Citations: 243
Authors: 58
Affiliations: 53
Identifiers
Doi:
10.1183/09031936.00104612
ISSN:
09031936
e-ISSN:
13993003
Research Areas
Disability
Health System And Policy
Study Design
Randomised Control Trial
Cohort Study