Why the study?
Due to high drug costs and local medical insurance coverage of ambrisentan, a drug transition from bosentan to ambrisentan occurred, prompting evaluation of its safety, efficacy, and tolerability in PAH patients.
Does transitioning from bosentan to ambrisentan maintain safety and efficacy in stable patients with pulmonary arterial hypertension?
Does transitioning from bosentan to ambrisentan maintain safety and efficacy in stable patients with pulmonary arterial hypertension?
Transitioning from bosentan to ambrisentan is safe and tolerable for stable PAH patients, maintaining exercise capacity and heart function without adverse effects on liver or renal function.
Transition to ambrisentan may ease costs in insured stable PAH patients; leaves open need for randomized long-term outcome data.
BACKGROUND: Pulmonary hypertension patients experienced a high financial burden due to the high cost of drug therapy, high incidence of comorbidities and hospitalizations. Endothelin receptor antagonists (ERAs) in PAH treatment showed a high cost. While ambrisentan has been covered by medical insurance of a local government of China, there has been a drug transition from bosentan to ambrisentan in treating PAH patients. We evaluated the safety, efficacy and tolerability of ambrisentan after drug transition. METHODS: Liver and renal functions were inspected at baseline, month 1, 3 and 6. NT-proBNP, echocardiographic variables, WHO functional class (WHO-FC), 6-minute walking distance (6MWD) were measured in the baseline and month 6 to evaluate the safety and efficacy. Quality of life (QOL) scale was used in the baseline and month 6 to investigate the tolerability and quality of life of PAH patients. RESULTS: Among 224 PAH patients, 49 stable PAH patients meet the inclusion criteria were enrolled, among which three patients discontinued during the study. Our results showed no difference in 6-minute walking distance (6MWD) of PAH patients from baseline and month 6. The liver and renal function, N-terminal pro-brain natriuretic peptide (NT-proBNP), WHO functional class (WHO-FC) showed no difference either. For echocardiography parameters, the left ventricular end-diastolic dimension (LVEDD) of month 6 decreased. Other parameters were no significant difference from the baseline. There was no difference in the QOL scale between baseline and month 6. CONCLUSION: Our results suggested that it is safe and tolerable for stable PAH patients to transition from bosentan to ambrisentan without influencing hematologic parameters or heart function.
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Chen et al. (2021) studied this question.
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