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Edema in Patient Switched to Macitentan from Bosentan and Ambrisentan in Pulmonary Arterial Hypertension
October 2015, Vol 148, No. 4_MeetingAbstracts
Pulmonary Vascular Disease | October 2015
Edema in Patient Switched to Macitentan from Bosentan and Ambrisentan in Pulmonary Arterial Hypertension Zeenat Safdar, MD; Aishwarya Thakur; Adaani Frost, MD Baylor College of Medicine, Houston TX Chest. 2015;148(4_MeetingAbstracts):939A. doi:10.1378/chest.2280587
Abstract 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: Pulmonary arterial hypertension (PAH) is a progressive disease for which several therapies have become available. Macitentan was recently FDA approved endothelin receptor antagonist (ETRA) for PAH treatment. Peripheral edema is considered an important treatment side effect of ETRAs and we present our experience in switching to macitentan from bosentan and ambrisentan in PAH patients and edema in these patients. METHODS: At Baylor Pulmonary Hypertension Program, 28 patients who switched from bosentan 125 mg orally twice a day or ambrisentan 10 mg daily to macitentan 10 mg orally daily (between October 2013 and February 2015) when macitentan became commercially available are presented. Patients were advised to take their last dose of bosetan after they had received macitentan at home and then take the first dose of macitentan the following morning. Baseline data and post-switch data was collected by way of 6 minute walk distance (6MWD), BNP, ALT and AST levels, WHO functional class, Borg dyspnea score, and presence of peripheral edema. All analyses are two sided and significance judged as p-value < 0.05. RESULTS: At the time of switch, age of the patients was 59±12 (mean±SD) years, duration of disease was 6±4 years, 25 were females, 14 were Caucasians, 32% were iPAH. At baseline, six-minute walk was 365 ± 79 meters, BNP was 95 ± 171 pg/ml, AST was 20 ± 8 U/L and ALT was 16 ± 8 U/L. At baseline, WHO FC II status was noted in 37% of the patients and edema was present in 46% of patients. After macitentan switch, follow-up data was available for 23 patients (3±2 months). As compared to baseline, follow-up BNP was 117 ± 225 pg/ml (p=0.366), AST was 20 ± 8 U/L (p=0.381), ALT was 25 ± 35 U/L (p=0.464) and 6MWD was 338 ± 94 meters (p=0.095). There was no significant change in edema in patients before and after the switch to macitentan, and the p-value in a proportion test controlling for the presence of edema was found to be not significant. CONCLUSIONS: Switch to macitentan was well tolerated with no significant change in edema. Switching between ETRAs appears to be safe with sustained exercise capacity, maintained FC and with no increased peripheral edema.
CLINICAL IMPLICATIONS: Patients on bosentan can be switched to macitentan with no increase edema incidence, decrease need for monthly liver function testing and improve patient compliance. DISCLOSURE: Zeenat Safdar: Consultant fee, speaker bureau, advisory committee, etc.: Gilead, united therapeutic, actelion, Bayer, Intermmune, University grant monies: NIH-NHLBI Adaani Frost: Consultant fee, speaker bureau, advisory committee, etc.: Gilead and Actelion; has received honoraria from Gilead, Actelion, and Pfizer; has provided expert testimony on diet pill litigation; has received grants from Gilead and Actelion and grants to Baylor for Institutional Review Board-approved research; and has received honoraria for her service on the REVEAL Steering Committee, which is supported by Actelion. The following authors have nothing to disclose: Aishwarya Thakur No Product/Research Disclosure Information
Pulmonary Vascular Disease | October 2015
Edema in Patient Switched to Macitentan from Bosentan and Ambrisentan in Pulmonary Arterial Hypertension Zeenat Safdar, MD; Aishwarya Thakur; Adaani Frost, MD Baylor College of Medicine, Houston TX Chest. 2015;148(4_MeetingAbstracts):939A. doi:10.1378/chest.2280587
Abstract 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: Pulmonary arterial hypertension (PAH) is a progressive disease for which several therapies have become available. Macitentan was recently FDA approved endothelin receptor antagonist (ETRA) for PAH treatment. Peripheral edema is considered an important treatment side effect of ETRAs and we present our experience in switching to macitentan from bosentan and ambrisentan in PAH patients and edema in these patients. METHODS: At Baylor Pulmonary Hypertension Program, 28 patients who switched from bosentan 125 mg orally twice a day or ambrisentan 10 mg daily to macitentan 10 mg orally daily (between October 2013 and February 2015) when macitentan became commercially available are presented. Patients were advised to take their last dose of bosetan after they had received macitentan at home and then take the first dose of macitentan the following morning. Baseline data and post-switch data was collected by way of 6 minute walk distance (6MWD), BNP, ALT and AST levels, WHO functional class, Borg dyspnea score, and presence of peripheral edema. All analyses are two sided and significance judged as p-value < 0.05. RESULTS: At the time of switch, age of the patients was 59±12 (mean±SD) years, duration of disease was 6±4 years, 25 were females, 14 were Caucasians, 32% were iPAH. At baseline, six-minute walk was 365 ± 79 meters, BNP was 95 ± 171 pg/ml, AST was 20 ± 8 U/L and ALT was 16 ± 8 U/L. At baseline, WHO FC II status was noted in 37% of the patients and edema was present in 46% of patients. After macitentan switch, follow-up data was available for 23 patients (3±2 months). As compared to baseline, follow-up BNP was 117 ± 225 pg/ml (p=0.366), AST was 20 ± 8 U/L (p=0.381), ALT was 25 ± 35 U/L (p=0.464) and 6MWD was 338 ± 94 meters (p=0.095). There was no significant change in edema in patients before and after the switch to macitentan, and the p-value in a proportion test controlling for the presence of edema was found to be not significant. CONCLUSIONS: Switch to macitentan was well tolerated with no significant change in edema. Switching between ETRAs appears to be safe with sustained exercise capacity, maintained FC and with no increased peripheral edema.
CLINICAL IMPLICATIONS: Patients on bosentan can be switched to macitentan with no increase edema incidence, decrease need for monthly liver function testing and improve patient compliance. DISCLOSURE: Zeenat Safdar: Consultant fee, speaker bureau, advisory committee, etc.: Gilead, united therapeutic, actelion, Bayer, Intermmune, University grant monies: NIH-NHLBI Adaani Frost: Consultant fee, speaker bureau, advisory committee, etc.: Gilead and Actelion; has received honoraria from Gilead, Actelion, and Pfizer; has provided expert testimony on diet pill litigation; has received grants from Gilead and Actelion and grants to Baylor for Institutional Review Board-approved research; and has received honoraria for her service on the REVEAL Steering Committee, which is supported by Actelion. The following authors have nothing to disclose: Aishwarya Thakur No Product/Research Disclosure Information