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The Role of Intravenous Selexipag in Managing PAH and Bridging Gaps in Oral Treatment: A Narrative Review.
Ther Clin Risk Manag
January 2025
Departments of Medicine and Cardiology, Westchester Medical Center and New York Medical College, Valhalla, NY, USA.
Pulmonary arterial hypertension (PAH) is a rare and potentially fatal condition characterized by progressive increases in blood pressure in the arteries of the lungs. Oral selexipag, approved by the Food and Drug Administration (FDA) in 2015 for the treatment of PAH, targets prostacyclin receptors on pulmonary arterial vascular smooth muscle and endothelial cells to improve blood flow through the lungs and reduce pulmonary vascular resistance. Oral selexipag is effective, but may be discontinued due to factors like side effects, emergency conditions, or inability to take oral medication, potentially leading to severe adverse events, such as rebound pulmonary hypertension and right heart failure.
View Article and Find Full Text PDFSafety and Efficacy of Selexipag for Pediatric Pulmonary Arterial Hypertension in Japanese Patients - An Open-Label Phase 2 Study.
Circ J
January 2025
Department of Echo-imaging Center, Aizawa Hospital.
Background: Selexipag, an oral prostacyclin (PGI) receptor agonist, is approved for adult patients with pulmonary arterial hypertension (PAH). This study evaluated the efficacy and safety of selexipag for Japanese pediatric patients with PAH.
Methods And Results: The study enrolled 6 patients who received selexipag twice daily at an individualized dose based on body weight; maintenance doses were determined for each patient by 12 weeks after starting administration.
[Combination drug therapy in pulmonary hypertension: switch from selexipaq to intravenous trepostinil].
Pneumologie
December 2024
Internal Medicine B, University Medicine Greifswald, Greifswald, Deutschland.
A wide range of substances is currently available for the treatment of patients with pulmonary arterial hypertension. The current recommendations for initial drug therapy are based on the patient's risk profile. For patients at high risk, an initial triple combination therapy with different substances including prostanoids is recommended.
View Article and Find Full Text PDFRisk of respiratory, thoracic, and mediastinal disorders associated with endothelin receptor antagonists and prostacyclin-related drugs in pulmonary hypertension: a disproportionality analysis based on FAERS.
Expert Opin Drug Saf
December 2024
Department of Rheumatology, Chongqing Emergency Medical Center, Chongqing University Central Hospital, Chongqing, China.
Background: Adverse drug events (ADEs) for endothelin receptor antagonists (ERAs) and prostacyclin-related drugs (PRDs) have been reported in clinical trials, but large-scale, real-world evaluations for respiratory, thoracic, and mediastinal disorders (RTMD) remain scarce.
Methods: A pharmacovigilance analysis of the FAERS database (Q1 2004~Q2 2024) used the reporting odds ratio (ROR) method for disproportionality analysis to assess the adverse drug events (ADEs) of ERAs and PRDs in pulmonary arterial hypertension, focusing on risks related to RTMD.
Results: Reports of ADEs for ERAs (bosentan, ambrisentan, and macitentan) were 15,286, 36795, and 17,497, respectively, and for PRDs (epoprostenol, treprostinil, iloprost, and selexipag) were 5,477, 57265, 3,247, and 5,504.
Population pharmacokinetics of selexipag for dose selection and confirmation in pediatric patients with pulmonary arterial hypertension.
CPT Pharmacometrics Syst Pharmacol
December 2024
Department of Clinical Pharmacology & Pharmacometrics, Janssen-Cilag S.p.A., Milan, Italy.
Article Synopsis
- Selexipag is an oral medication used to treat pulmonary arterial hypertension (PAH) in adults, but there are currently no approved treatments targeting this pathway for children.
- The researchers aimed to establish appropriate dosing for pediatric patients by using a pharmacokinetic model derived from adult data, creating weight-based dosing groups with specific starting and maximum doses for different age brackets.
- A clinical study involving 63 pediatric PAH patients showed that the adjusted doses for children resulted in similar drug exposure levels to the adult population, confirming the dosing regimen's safety and efficacy for kids aged 2 to under 18.
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