Key result
Switching from bosentan to macitentan in PAH is linked to a ~34 m 6MWD increase.
Why the study?
To perform a prospective clinical assessment of patients with pulmonary arterial hypertension who switched from bosentan to macitentan due to inadequate response.
Does switching from bosentan to macitentan improve clinical, functional, and haemodynamic parameters in patients with pulmonary arterial hypertension with inadequate response?
Observational (n=50)
Open-label
Does switching from bosentan to macitentan improve clinical, functional, and haemodynamic parameters in patients with pulmonary arterial hypertension with inadequate response?
Mean Difference: 34
p-value: p=0.002
Switching from bosentan to macitentan in patients with pulmonary arterial hypertension and inadequate clinical response may improve functional class, exercise capacity, and haemodynamics with a favorable safety profile.
Even though pulmonary arterial hypertension (PAH) remains an incurable disease, the combination of PAH‐specific therapies allowed treatment strategies to evolve from symptom‐based ones to others that aim to move patients to low‐risk conditions. Endothelin‐1 (ET‐1) receptor antagonists emerged as specific‐PAH drugs that can be used in combination with other specific therapies. This work aimed to perform a prospective clinical assessment of patients with PAH that switched from bosentan to macitentan (POTENT), due to inadequate response. POTENT is a prospective, open‐label, single‐arm, uncontrolled study including PAH patients from our ongoing SAUDIPH registry. It enrolled 50 PAH patients divided as follows: idiopathic/heritable pulmonary arterial hypertension (I/HPAH); n = 24; PAH associated with congenital heart disease, n = 19; PAH associated with connective tissue diseases, n = 5; and pulmonary veno‐occlusive disease and/or pulmonary capillary haemangiomatosis (PVOD/PCH), n = 2. At baseline, most patients were in World Health Organization Functional Class (WHO FC) II/III (52.0%). After switching to macitentan, patients were more likely to be in WHO FC I/II (78%) and 22% of the overall cohort moved to a lower risk condition, with three low risk stratification parameters. Mean 6‐min walking distance increased about 34 m after 12 months, with a significant mean change over time (12.63 ± 11.69 at month 3 vs. 40.75 ± 12.57 at month 12, p = 0.002). Most haemodynamic parameters decreased over time, with corresponding negative mean changes (p < 0.001). The safety of macitentan was confirmed by the absence of anaemia and liver injury; clinical worsening was observed only in a small group of patients. In general, macitentan might be a valid alternative to bosentan in PAH stable patients on combination therapy with insufficient clinical response, and presenting intermediate and high‐risk parameters. We anticipate that studying this strategy in PAH subgroups would further clarify its potential and limitations.
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Aldalaan et al. (2022) conducted an observational in Pulmonary arterial hypertension (n=50). Macitentan vs. Bosentan (baseline) was evaluated on 6-minute walking distance (MD 34 m, p=0.002). Switching from bosentan to macitentan in patients with pulmonary arterial hypertension increased mean 6-minute walking distance by approximately 34 m after 12 months (p=0.002).
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