RT Journal Article
SR Electronic
T1 Transitioning pulmonary arterial hypertension patients from bosentan to macitentan: efficacy and safety data
JF European Respiratory Journal
JO Eur Respir J
FD European Respiratory Society
SP PA3536
DO 10.1183/1393003.congress-2017.PA3536
VO 50
IS suppl 61
A1 Mario Santos
A1 Fabienne Gonçalves
A1 Luísa Carvalho
A1 Abílio Reis
YR 2017
UL http://erj.ersjournals.com/content/50/suppl_61/PA3536.abstract
AB 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.