SESSION TITLE: Pulmonary Arterial Hypertension Posters I
SESSION TYPE: Original Investigation Poster
PRESENTED ON: Wednesday, October 28, 2015 at 01:30 PM - 02:30 PM
PURPOSE: Macitentan is an endothelin receptor antagonist (ERA) that was approved by the FDA in 2013 for the treatment of pulmonary arterial hypertension. We present our experience in switching patients from bosentan to macitentan.
METHODS: From 11/1/2013 to 1/1/2015 there were 25 patients at Christiana Hospital PAH Program switched from bosentan to macitentan. Two were excluded from analysis, one due to trauma and one due to development of cancer. All patients were switched from bosentan 125mg twice daily to macitentan 10mg once daily. Data was collected at baseline and after macitentan switch.
RESULTS: Mean age was 55.6 ± 17.9 years, 16 were female. Patients were classified as WHO group I (19 patients) and WHO group IV (4 patients). WHO Group I patients included: 10 idiopathic, 3 congenital heart disease, 6 connective tissue disease and 1 portopulmonary. Concomitant PAH drugs at time of macitentan initiation included tadalafil (8 patients), sildenafil (5 patients), treprostinil IV/SC (5 patients), epoprostenol (1 patient), treprostinil inhaled (7 patients) and selixipag (1 patient). The mean time since initial diagnosis to macitentan switch was 61.1 ± 50.9 months. At baseline, 3 patients were WHO FC 1, 13 were WHO FC 2, and 7 were WHO FC 3. 6MWD pre and post switch (6 patients) was 478 ± 81 and 412 ± 71 m respectively (p = 0.095). AST pre and post (11 patients) was 22 ± 9 and 23 ± 11 IU/L respectively (p=0.921). ALT pre and post (11 patients) was 23 ± 10 and 20 ± 10 IU/L (p=0.291). BNP (12 patients) was 853 ± 1741 pre and 399 ± 867 pg/ml post (p=0.577). Hemoglobin (20 patients) pre and post was 12.2 ± 2.0 and 12.0 ± 2.3 g/dl respectively (p=0.479). 7 patients developed peripheral edema and 1 patient experienced worsening functional class. Out of a total of 23 patients, 2 patients discontinued, 1 due to worsening functional class and 1 due to worsening peripheral edema. There were no deaths.
CONCLUSIONS: Transition from bosentan to macitentan was well tolerated by 91% of our subjects. There was no significant change in liver function studies, hemoglobin, BNP or 6MWD. While 7 patients in our study developed mild edema after being switched to macitentan, edema is a known occurrence associated with PAH and it is difficult to draw conclusions whether the edema was directly related to macitentan.
CLINICAL IMPLICATIONS: Switching bosentan to macitentan appears to be safe and well tolerated. Since macitentan is once daily, and does not require liver function testing monitoring, this may improve patient compliance.
DISCLOSURE: Carol Gray: Consultant fee, speaker bureau, advisory committee, etc.: Speaker Bureau for Actilion Pharmaceuticals The following authors have nothing to disclose: Sharon Jones, Jeffrey Stewart
No Product/Research Disclosure Information