Key result
Selexipag reduced pulmonary vascular resistance by a placebo-corrected −93.5 dyn·s·cm−5 after 20 weeks in patients with CTEPH, but did not significantly improve 6-min walk distance or WHO-FC.
Why the study?
Does selexipag improve pulmonary vascular resistance in patients with CTEPH who are inoperable or have persistent pulmonary hypertension after PEA or BPA?
RCT (n=78)
Double-blind
Randomized
Does selexipag improve pulmonary vascular resistance in patients with CTEPH who are inoperable or have persistent pulmonary hypertension after PEA or BPA?
Selexipag significantly reduced pulmonary vascular resistance in Japanese patients with CTEPH, leading to its approval in Japan, despite no significant improvements in functional outcomes.
Extract Selexipag, an orally available prostacyclin receptor agonist, is globally approved for the treatment of pulmonary arterial hypertension (PAH) and has also been investigated in patients with chronic thromboembolic pulmonary hypertension (CTEPH). In 2022, the European Respiratory Journal published the results of a randomised, double-blind, placebo-controlled trial involving 78 Japanese patients with CTEPH who were inoperable or had persistent pulmonary hypertension after pulmonary endarterectomy (PEA) or pulmonary balloon angioplasty (BPA) [1]. This study met its primary endpoint, showing a placebo-corrected change in pulmonary vascular resistance (PVR) of −93.5 dyn·s·cm⁻⁵ after 20 weeks. However, no significant improvements were observed in 6-min walk distance and World Health Organization functional class (WHO-FC). Clinical worsening events occurred in one patient assigned to selexipag and one patient assigned to placebo. Based on this study, selexipag was approved for the treatment of CTEPH in Japan.
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Marius M. Hoeper (2024) conducted an RCT in chronic thromboembolic pulmonary hypertension (CTEPH) (n=78). Selexipag vs. placebo was evaluated on change in pulmonary vascular resistance (PVR) (MD -93.5). Selexipag reduced pulmonary vascular resistance by a placebo-corrected −93.5 dyn·s·cm−5 after 20 weeks in patients with CTEPH, but did not significantly improve 6-min walk distance or WHO-FC.
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