What is the clinical evidence from this study?

Study design: Cohort. Population: Pulmonary Arterial Hypertension (n=157). Intervention: Macitentan vs. Baseline (Ambrisentan). Primary outcome: 6-minute walk distance (6 MWD) at 12 months (p=0.004).

January 12, 2022Open Access

The Transition From Ambrisentan to Macitentan in Patients With Pulmonary Arterial Hypertension: A Real-word Prospective Study

YCYusi ChenCentral South University JLJun LuoCentral South University JCJingyuan ChenPeking University

Resultado clave

Transitioning from ambrisentan to macitentan was successful in 92.4% of patients with pulmonary arterial hypertension and significantly improved 6-minute walk distance from 424.74 m at baseline to 440.59 m at 12 months.

Diseño del estudio

Tipo

Cohort (n=157)

Enmascaramiento

Open-label

Multicéntrico

PICO estructurado

Does transitioning from ambrisentan to macitentan improve efficacy and maintain safety in patients with stable pulmonary arterial hypertension?

Población

157 adult patients with stable pulmonary arterial hypertension previously treated with ambrisentan for at least 6 months, transitioned to macitentan and followed for 12 months.

Intervención

Macitentan 10 mg oral once daily (rapid transition from ambrisentan)

Resultado

Safety, tolerability, and efficacy (assessed by adverse events, 6MWD, WHO FC, NT-proBNP, echocardiography, and REVEAL 2.0 risk score) at 12 monthssurrogate

Transitioning from ambrisentan to macitentan in stable PAH patients is feasible and associated with improved exercise capacity and hemodynamics, though monitoring for anemia and menstrual disorders is warranted.

Resultado numérico

Tasa de eventos absoluta: 440.59% vs 424.74%

valor p: p=0.004

Limitaciones

Open-label nature of the trial with no placebo or active comparator
Patient-reported QOL and treatment administration time data were inherently subjective
Long-term data were limited by missing data and might have been affected by completer bias
Echocardiographic parameters were only obtained from 75 patients (52%)

Resumen

Background: In a long-term event-driven trial, macitentan has demonstrated beneficial time to clinical worsening in patients with pulmonary arterial hypertension (PAH) and reduced PAH-related hospitalization rates compared with placebo. Macitentan is the most recently approved endothelin receptor antagonist (ERA) and is the first ERA that has shown efficacy for morbidity and mortality in PAH patients; therefore, patients and physicians may consider converting treatment from ambrisentan to macitentan. Our study evaluated the safety, efficacy, and quality of life in PAH patients transitioning from ambrisentan to macitentan. Methods: This was a real-world, prospective study with a 12-month follow-up. PAH patients who had received stable doses of ambrisentan for over 3 months, were within the World Health Organization Functional Class II/III, and 6-min walk distance ≥ of 250 m were enrolled. The study included a screening period, followed by a transition phase, after which patients entered the long-term follow-up. Clinical data and treatment satisfaction outcomes were collected to assess and monitor the safety and efficacy of the transition. The trial was registered at the Chinese Clinical Trial Registry ( www.chictr.org.cn ; No. ChiCTR2000034898). Results: One hundred and fifty-seven enrolled PAH patients completed the transition. All criteria for continuous treatment transition were met by 145 patients (92.4%). Results showed improvements in exercise capacity, cardiac function, and hemodynamics compared with baseline. During the process, 4 patients discontinued macitentan due to adverse events. There was no statistical difference in the overall incidence of adverse events before and after the transition. Conclusion: Transition to macitentan from ambrisentan was successful and well-tolerated by PAH patients, and was associated with greater efficacy and satisfaction.

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