{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,26]],"date-time":"2026-09-26T10:38:30Z","timestamp":1790419110012,"version":"4.1.0"},"reference-count":26,"publisher":"European Respiratory Society (ERS)","issue":"2","funder":[{"DOI":"10.13039\/100005646","name":"Actelion Pharmaceuticals","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100005646","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["publications.ersnet.org"],"crossmark-restriction":true},"short-container-title":["Eur Respir J"],"accepted":{"date-parts":[[2017,11,20]]},"published-print":{"date-parts":[[2018,2]]},"abstract":"<jats:p>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.<\/jats:p>\n                  <jats:p>63 patients with PH-LHD and diastolic pressure gradient \u22657\u2005mmHg and pulmonary vascular resistance (PVR) &gt;3WU were randomised to macitentan 10\u2005mg (n=31) or placebo (n=32) for 12\u2005weeks. The main end-point assessed a composite of significant fluid retention (weight gain \u22655% or \u22655\u2005kg because of fluid overload or parenteral diuretic administration) or worsening in New\u00a0York 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.<\/jats:p>\n                  <jats:p>\n                    Seven macitentan-treated and four placebo-treated patients experienced significant fluid retention\/worsening functional class; treatment difference, 10.08% (95% CI \u221215.07\u201333.26; p=0.34). The difference, driven by the fluid retention component, was apparent within the first month. At week 12,\n                    <jats:italic>versus<\/jats:italic>\n                    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\u20130.7) L\u00b7min\n                    <jats:sup>\u22121<\/jats:sup>\n                    \u00b7m\n                    <jats:sup>\u22122<\/jats:sup>\n                    ) and decrease in NT-proBNP (0.77 (0.55\u20131.08)) was observed. Adverse events and serious adverse events were numerically more frequent with macitentan\n                    <jats:italic>versus<\/jats:italic>\n                    placebo.\n                  <\/jats:p>\n                  <jats:p>\n                    Macitentan-treated patients were quantitatively more likely to experience significant fluid retention\n                    <jats:italic>versus<\/jats:italic>\n                    placebo. Macitentan resulted in no significant changes in any exploratory end-points.\n                  <\/jats:p>","DOI":"10.1183\/13993003.01886-2017","type":"journal-article","created":{"date-parts":[[2018,2,8]],"date-time":"2018-02-08T05:08:45Z","timestamp":1518066525000},"page":"1701886","update-policy":"https:\/\/doi.org\/10.1183\/ers-crossmark-policy","source":"Crossref","is-referenced-by-count":191,"title":["Macitentan in pulmonary hypertension due to left ventricular dysfunction"],"prefix":"10.1183","volume":"51","author":[{"given":"Jean-Luc","family":"Vachi\u00e9ry","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8394-9809","authenticated-orcid":false,"given":"Marion","family":"Delcroix","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hikmet","family":"Al-Hiti","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michela","family":"Efficace","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Martin","family":"Hutyra","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gabriela","family":"Lack","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kelly","family":"Papadakis","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lewis J.","family":"Rubin","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"81","published-online":{"date-parts":[[2018,2,7]]},"reference":[{"key":"2024101909302593000_51.2.1701886.1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2013.10.033"},{"key":"2024101909302593000_51.2.1701886.2","doi-asserted-by":"publisher","DOI":"10.1093\/eurheartj\/ehv317"},{"key":"2024101909302593000_51.2.1701886.3","doi-asserted-by":"publisher","DOI":"10.1093\/eurheartj\/ehv512"},{"key":"2024101909302593000_51.2.1701886.4","first-page":"2869","article-title":"Pulmonary hypertension in heart failure with preserved ejection fraction: a plea for proper phenotyping and further research","volume":"38","author":"Hoeper","year":"2016","journal-title":"Eur Heart J"},{"key":"2024101909302593000_51.2.1701886.5","doi-asserted-by":"publisher","DOI":"10.1161\/01.CIR.85.2.504"},{"key":"2024101909302593000_51.2.1701886.6","doi-asserted-by":"publisher","DOI":"10.1093\/oxfordjournals.eurheartj.a015228"},{"key":"2024101909302593000_51.2.1701886.7","doi-asserted-by":"publisher","DOI":"10.1016\/j.jchf.2017.02.021"},{"key":"2024101909302593000_51.2.1701886.8","doi-asserted-by":"publisher","DOI":"10.1161\/01.CIR.0000038497.80095.E1"},{"key":"2024101909302593000_51.2.1701886.9","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(04)16723-8"},{"key":"2024101909302593000_51.2.1701886.10","unstructured":"Actelion Pharmaceuticals. Opsumit prescribing information. 2016. http:\/\/opsumit.com\/opsumit-prescribing-information.pdf Date last accessed: May, 2017."},{"key":"2024101909302593000_51.2.1701886.11","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1213917"},{"key":"2024101909302593000_51.2.1701886.12","doi-asserted-by":"publisher","DOI":"10.1016\/S0002-8703(97)70105-4"},{"key":"2024101909302593000_51.2.1701886.13","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2013.2024"},{"key":"2024101909302593000_51.2.1701886.14","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCULATIONAHA.113.001458"},{"key":"2024101909302593000_51.2.1701886.15","doi-asserted-by":"publisher","DOI":"10.1378\/chest.14-0106"},{"key":"2024101909302593000_51.2.1701886.16","unstructured":"ClinicalTrials.gov. Phosphodiesterase Type 5 Inhibition With Tadalafil Changes Outcomes in Heart Failure (PITCH-HF). https:\/\/clinicaltrials.gov\/ct2\/show\/NCT01910389?term=NCT01910389&rank=1. Date last accessed: May 2017. 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