Macitentan for the treatment of idiopathic pulmonary fibrosis: the randomised controlled MUSIC trial
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Macitentan for the treatment of idiopathic pulmonary fibrosis: the randomised controlled MUSIC trial. / Raghu, Ganesh; Million-Rousseau, Rachel; Morganti, Adele; Perchenet, Loyc; Behr, Juergen; MUSIC Study Group.
in: EUR RESPIR J, Jahrgang 42, Nr. 6, 01.12.2013, S. 1622-32.Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung
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T1 - Macitentan for the treatment of idiopathic pulmonary fibrosis: the randomised controlled MUSIC trial
AU - Raghu, Ganesh
AU - Million-Rousseau, Rachel
AU - Morganti, Adele
AU - Perchenet, Loyc
AU - Behr, Juergen
AU - MUSIC Study Group
AU - Nashan, Björn
PY - 2013/12/1
Y1 - 2013/12/1
N2 - 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.
AB - 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.
U2 - 10.1183/09031936.00104612
DO - 10.1183/09031936.00104612
M3 - SCORING: Journal article
C2 - 23682110
VL - 42
SP - 1622
EP - 1632
JO - EUR RESPIR J
JF - EUR RESPIR J
SN - 0903-1936
IS - 6
ER -