Macitentan in pulmonary hypertension due to left ventricular dysfunction
The result's identifiers
Result code in IS VaVaI
<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00023001%3A_____%2F18%3A00076539" target="_blank" >RIV/00023001:_____/18:00076539 - isvavai.cz</a>
Alternative codes found
RIV/61989592:15110/18:73590774
Result on the web
<a href="http://erj.ersjournals.com/content/51/2/1701886" target="_blank" >http://erj.ersjournals.com/content/51/2/1701886</a>
DOI - Digital Object Identifier
<a href="http://dx.doi.org/10.1183/13993003.01886-2017" target="_blank" >10.1183/13993003.01886-2017</a>
Alternative languages
Result language
angličtina
Original language name
Macitentan in pulmonary hypertension due to left ventricular dysfunction
Original language description
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.
Czech name
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Czech description
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Classification
Type
J<sub>imp</sub> - Article in a specialist periodical, which is included in the Web of Science database
CEP classification
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OECD FORD branch
30201 - Cardiac and Cardiovascular systems
Result continuities
Project
—
Continuities
N - Vyzkumna aktivita podporovana z neverejnych zdroju
Others
Publication year
2018
Confidentiality
S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů
Data specific for result type
Name of the periodical
European respiratory journal
ISSN
0903-1936
e-ISSN
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Volume of the periodical
51
Issue of the periodical within the volume
2
Country of publishing house
GB - UNITED KINGDOM
Number of pages
9
Pages from-to
"art. no. 1701886"
UT code for WoS article
000424396500017
EID of the result in the Scopus database
2-s2.0-85044309221