Transitioning pulmonary arterial hypertension patients from bosentan to macitentan: efficacy and safety data

Published on Sep 1, 2017in European Respiratory Journal11.807
· DOI :10.1183/1393003.congress-2017.PA3536
Mário Santos13
Estimated H-index: 13
Fabienne Gonçalves3
Estimated H-index: 3
+ 1 AuthorsAbílio Reis4
Estimated H-index: 4
Introduction: In addition to several pharmacodynamics advantages over bosentan, macitentan has once-a-day profile, less liver toxicity and drug interactions, and outcome data showing improved mortality and morbidity in pulmonary arterial hypertension (PAH) patients. We aimed to examine the effect of switching bosentan to macitentan on clinical status of PAH patients. Methods and Results: We conducted a retrospective observational study in a cohort of 32 patients with PAH that transitioned from bosentan to macitentan between 1st January 2015 to 31st December 2016. We compared clinical data at baseline (before starting macitentan) and 6-12 months after (mean time interval of 7±2 months). Mean exposure time for bosentan was 5±2 years. Studied patients had a mean age of 46±17 years and 60% were female. 14 congenital heart disease-associated, 10 idiopathic/heritable, 1 connective-disease associated and 7 chronic thromboembolic disease (CTEPH). No differences were found in NYHA functional class (2.1±0.7 vs 2.1±0.6; p=0.99), 6-minute walking distance (440±121 vs 442±116 m; p=0.68), and proBNP (314 [102-731] vs 386 [124-795] ng/mL; p=0.87) between observations. No differences were observed between group 1 PAH and CTEPH patients. Liver function tests were stable (AST: 21±14 vs 20±17 UI/L, p=0.84; ALT: 21±9 vs 22±10 UI/L, p=0.64). We observed a mean drop of hemoglobin of 0.5±1.4 g/dL in 9 (28%) patients with a >1g/dL decrease (follow-up mean Hb of 15.5±4.0 g/dL). Conclusions: The switch from bosentan to macitentan was well tolerated and safe. Hemoglobin plasma levels should be monitored as a subset of patients might show a hemoglobin decrease.
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Background Macitentan is the latest endothelin-receptor antagonist (ERA) approved for the treatment of pulmonary arterial hypertension (PAH), presenting enhanced properties over previous ERAs.