Efficacy and safety of switching from bosentan or ambrisentan to macitentan in pulmonary arterial hypertension: A systematic review and meta-analysis

Abstract

BackgroundThere is little evidence of the effectiveness of switching from the endothelin receptor antagonists (ERAs) bosentan and ambrisentan to a novel ERA, macitentan, in patients with pulmonary arterial hypertension (PAH). Therefore, a systematic review and meta-analysis was performed to evaluate the efficacy and safety of patients with PAH switching from other ERAs to macitentan.MethodsWe retrieved the relevant literature published before January 2022 for the meta-analysis from the PubMed, EMBASE, and Cochrane Library databases. Efficacy included changes in the 6-min walk distance (6MWD), World Health Organization functional class (WHO-FC), N-terminal pro-brain natriuretic peptide (NT-proBNP) levels, hemodynamics, echocardiography and survival.ResultsNine studies, consisting of 408 PAH patients, that met the inclusion criteria were included. The switch from bosentan or ambrisentan to macitentan effectively increased the 6MWD by 20.71 m (95% CI: 10.35-31.07, P < 0.00001, I2 = 0%). Six months after conversion, the tricuspid annular plane systolic excursion was found to improve from 19.0 ± 4.0 to 21.0 ± 5.0 mm in adults and from 16.00 ± 5.0 to 18.25 ± 4.8 mm in children. Ordinal logistic regression showed that the WHO-FC significantly improved by 0.412 (95% CI: 0.187-0.908, P = 0.028). The switch did not show significant improvement in NT-proBNP levels. In addition, the switch was well tolerated.ConclusionThe switch from bosentan or ambrisentan to macitentan significantly increased the 6MWD in PAH patients, improved the WHO-FC, and exerted safety benefits. The effects of the switch on NT-proBNP levels, hemodynamics, and echocardiography still need to be further confirmed.Systematic review registration[https://www.crd.york.ac.uk/prospero/], identifier [CRD42021292554].

Comparative Treatment Persistence and Adherence to Endothelin Receptor Antagonists Among Patients with Pulmonary Arterial Hypertension in Japan: A Real-World Administrative Claims Database Study

“…Recent real-world studies showed that the switch from bosentan or ambrisentan to macitentan was associated with greater efficacy and treatment satisfaction, as measured by the 6-min walk distance, WHO functional class, and quality-of-life questionnaires [34,35]. Patients treated with macitentan also exhibited fewer adverse effects compared to bosentan and ambrisentan [36].…”

Eurasian guidelines for the diagnosis and treatment of pulmonary hypertension (2023)

“…После однократного ежедневного приема концентрация мацитентана и его активного метаболита в плазме крови достигают устойчивого уровня примерно через 7 дней [9,229]. По данным метаанализа 9 проспективных когортных исследований у 408 больных ЛАГ показано, что замена бозентана или амбризентана на мацитентан способствовала улучшению дистанции в ТШХ, ФК с хорошим профилем безопасности при отсутствии значимого влияния на уровни NT-proBNP, гемодинамику и параметры ЭхоКГ [232]. В связи с отсутствием многоцентровых РКИ по изучению влияния переключения АРЭ на клиническое течение ЛАГ целесообразна замена только при развитии НЯ или неблагоприятных межлекарственных взаимодействиях.…”