Author + information
- Jean-Luc Vachierya,b,
- Marion Delcroixa,b,
- Hikmet Al-Hitia,b,
- Michela Efficacea,b,
- Martin Hutyraa,b,
- Gabriela Lacka,b,
- Kelly Papadakisa,b and
- Lewis Rubina,b
Background: The randomized, double blind, phase 2 MELODY-1 study evaluated macitentan for pulmonary hypertension (PH) due to left heart disease in patients with combined post- and pre-capillary PH.
Methods: Patients were randomized 1:1 to macitentan 10 mg (n=31) or placebo (n=32) for 12 weeks. The main study endpoint, related to safety, assessed a composite of significant fluid retention (weight gain ≥5 kg/≥5 % due to fluid overload or the need for parenteral administration of diuretics) or worsening in New York Heart Association functional class from baseline to end of treatment. Other exploratory endpoints included N-terminal pro-brain natriuretic peptide (NT-proBNP) and hemodynamics at Week 12.
Results: Of the 63 patients, 7 macitentan-treated and 4 placebo-treated experienced significant fluid retention or worsening functional class; treatment difference: 10.08% (95% confidence limits -15.07, 33.26; p=0.34). The difference was driven by the fluid-retention component and was apparent within the first month. At Week 12, compared with placebo, the macitentan group showed no change in pulmonary vascular resistance, mean right atrial pressure, and pulmonary arterial wedge pressure; the increase in cardiac index and decrease in NT-proBNP were not statistically significant (Table).
Conclusion: In MELODY-1, macitentan-treated patients were more likely to experience the main composite endpoint vs placebo.
Room 147 B
Saturday, March 18, 2017, 9:17 a.m.-9:27 a.m.
Session Title: Highlighted Original Research: Pulmonary Hypertension and Venous Thrombo-embolic Disease and the Year in Review
Abstract Category: 35. Pulmonary Hypertension and Pulmonary Thrombo-embolic Disease
Presentation Number: 904-14
- 2017 American College of Cardiology Foundation