PT  - JOURNAL ARTICLE
AU  - Jean-Luc Vachiéry
AU  - Marion Delcroix
AU  - Hikmet Al-Hiti
AU  - Michela Efficace
AU  - Martin Hutyra
AU  - Gabriela Lack
AU  - Kelly Papadakis
AU  - Lewis J. Rubin
TI  - Macitentan in pulmonary hypertension due to left ventricular dysfunction
AID  - 10.1183/13993003.01886-2017
DP  - 2018 Feb 01
TA  - European Respiratory Journal
PG  - 1701886
VI  - 51
IP  - 2
4099  - http://erj.ersjournals.com/content/51/2/1701886.short
4100  - http://erj.ersjournals.com/content/51/2/1701886.full
SO  - Eur Respir J2018 Feb 01; 51
AB  - The MELODY-1 study evaluated macitentan for pulmonary hypertension because of left heart disease (PH-LHD) in patients with combined post- and pre-capillary PH.63 patients with PH-LHD and diastolic pressure gradient ≥7 mmHg and pulmonary vascular resistance (PVR) >3WU were randomised to macitentan 10 mg (n=31) or placebo (n=32) for 12 weeks. The main end-point assessed a composite of significant fluid retention (weight gain ≥5% or ≥5 kg because of fluid overload or parenteral diuretic administration) or worsening in New York Heart Association functional class from baseline to end of treatment. Exploratory end-points included changes in N-terminal pro-brain natriuretic peptide (NT-proBNP) and haemodynamics at week 12.Seven macitentan-treated and four placebo-treated patients experienced significant fluid retention/worsening functional class; treatment difference, 10.08% (95% CI −15.07–33.26; p=0.34). The difference, driven by the fluid retention component, was apparent within the first month. At week 12, versus placebo, the macitentan group showed no change in PVR, mean right atrial pressure or pulmonary arterial wedge pressure; a non-significant increase in cardiac index (treatment effect 0.4 (95% CI 0.1–0.7) L·min−1·m−2) and decrease in NT-proBNP (0.77 (0.55–1.08)) was observed. Adverse events and serious adverse events were numerically more frequent with macitentan versus placebo.Macitentan-treated patients were quantitatively more likely to experience significant fluid retention versus placebo. Macitentan resulted in no significant changes in any exploratory end-points.In combined post- and pre-capillary PH patients, macitentan was associated with increased incidence of significant fluid retention versus placebo http://ow.ly/leop30hBkQm