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Macitentan in pulmonary hypertension due to left ventricular dysfunction

Identifikátory výsledku

  • Kód výsledku v 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>

  • Nalezeny alternativní kódy

    RIV/61989592:15110/18:73590774

  • Výsledek na webu

    <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>

Alternativní jazyky

  • Jazyk výsledku

    angličtina

  • Název v původním jazyce

    Macitentan in pulmonary hypertension due to left ventricular dysfunction

  • Popis výsledku v původním jazyce

    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 &gt;= 7 mmHg and pulmonary vascular resistance (PVR) &gt;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 &gt;= 5% or &gt;= 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.

  • Název v anglickém jazyce

    Macitentan in pulmonary hypertension due to left ventricular dysfunction

  • Popis výsledku anglicky

    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 &gt;= 7 mmHg and pulmonary vascular resistance (PVR) &gt;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 &gt;= 5% or &gt;= 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.

Klasifikace

  • Druh

    J<sub>imp</sub> - Článek v periodiku v databázi Web of Science

  • CEP obor

  • OECD FORD obor

    30201 - Cardiac and Cardiovascular systems

Návaznosti výsledku

  • Projekt

  • Návaznosti

    N - Vyzkumna aktivita podporovana z neverejnych zdroju

Ostatní

  • Rok uplatnění

    2018

  • Kód důvěrnosti údajů

    S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Údaje specifické pro druh výsledku

  • Název periodika

    European respiratory journal

  • ISSN

    0903-1936

  • e-ISSN

  • Svazek periodika

    51

  • Číslo periodika v rámci svazku

    2

  • Stát vydavatele periodika

    GB - Spojené království Velké Británie a Severního Irska

  • Počet stran výsledku

    9

  • Strana od-do

    "art. no. 1701886"

  • Kód UT WoS článku

    000424396500017

  • EID výsledku v databázi Scopus

    2-s2.0-85044309221