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. 2022 May 3;12(2):e12083.
doi: 10.1002/pul2.12083. eCollection 2022 Apr.

Prospective clinical assessment of patients with pulmonary arterial hypertension switched from bosentan to macitentan (POTENT)

Abdullah M Aldalaan  1 , Sarfraz A Saleemi  1 , Ihab Weheba  1 , Abeer Abdelsayed  1 , Maha M Aleid  2 , Fatima Alzubi  1 , Hamdeia Zaytoun  1 , Nadeen Alharbi  1
Affiliations

Prospective clinical assessment of patients with pulmonary arterial hypertension switched from bosentan to macitentan (POTENT)

Abdullah M Aldalaan et al. Pulm Circ. .

Abstract

Even though pulmonary arterial hypertension (PAH) remains an incurable disease, the combination of PAH-specific therapies allowed evolving from symptom-based strategies to others aiming 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.

Keywords: Bosentan; Macitentan; efficacy; pulmonary arterial hypertension; safety; switch.

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Conflict of interest statement

The authors declare no conflicts of interest.

Figures

Figure 1
Figure 1
Change of WHO FC after switching from bosentan to macitentan. (a) Distribution of patients (%) in WHO FC I/II and III/IV, over time. (b) Probability of a patient being on WHO FC III/IV, over time. WHO FC, World Health Organization Functional Class
Figure 2
Figure 2
Estimated change of 6MWD over time, after switching from bosentan to macitentan. CI, confidence interval; 6MWD, 6‐min walking distance
Figure 3
Figure 3
Estimated change in NT‐proBNP over time, after switch from bosentan to macitentan. CI, confidence interval; NT‐proBNP, N‐terminal pro‐B‐type natriuretic peptide
Figure 4
Figure 4
Clinical worsening after switching from bosentan to Macitentan
Figure 5
Figure 5
Patients with low‐risk criteria* at baseline and 4th visit. *WHO FC (classes I and II), 6MWD (>440 m), and NT‐proBNP (<300 ng/L). LRC, low risk criteria; WHO FC, World Health Organization Functional Class
See this image and copyright information in PMC

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