What are the real-world practice patterns and adverse event characteristics of selexipag in Korean patients with pulmonary arterial hypertension?
In real-world practice, adverse events with selexipag in PAH patients are more frequent during titration but do not show a dose-dependent increase in frequency or severity, supporting the safety of titrating to optimal individual doses.
BACKGROUND: Optimizing an individual dose with careful management of adverse events (AEs) is essential in the treatment with selexipag approved for pulmonary arterial hypertension (PAH). This study aims to identify real-world practice patterns and AE characteristics of selexipag. RESEARCH DESIGN AND METHODS: This multicenter, longitudinal, observational study included Korean patients with PAH who initiated with selexipag and were followed up to 24 weeks. The dose-titration pattern, AE incidences by dosing and time course, recovery pattern from AEs, and relationship between doses and AE incidences were evaluated. RESULTS: Data for 113 patients were included in the analysis. The individual maintenance dose ranged between 200 and 3,200 µg/day. More often AEs were occurred in the titration phase than maintenance phase. There was no significant difference in AE incidences according to the distribution of titration and maintenance doses. The four most common AEs were diarrhea, headache, nausea/vomiting, and myalgia without showing a dose-dependent trend in either frequency or severity. The recovery rates were between 65.0% and 76.9% with a median time to recovery of 15-70 days (range, 2-233). CONCLUSION: Our finding that AE incidence did not increase with increasing dose of selexipag would provide supportive real-world evidence on the management of optimal dose and safety.
Chang et al. (Fri,) studied this question.