Real-world practice patterns and characteristics of adverse events with selexipag in Korean patients with pulmonary arterial hypertension

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-worldpractice 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-titrationpattern, 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 mu g/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-dependenttrend in either frequency or severity. The recovery rates were between 65.0% and 76.9% with a median time to recovery of15-70 days (range, 2-233). Conclusion Our finding that AE incidence did not increase with increasing dose of selexipag would provide supportive real-worldevidence on the management of optimal dose and safety.

Automated summary

This study aimed to investigate the real-world practice patterns and adverse event (AE) characteristics of selexipag in patients with pulmonary arterial hypertension (PAH). The results showed that AE incidence was higher during the titration phase compared to the maintenance phase, but there was no association between AE incidence and dose distribution. The most common AEs were diarrhea, headache, nausea/vomiting, and myalgia, and they were not dose-dependent in terms of frequency or severity. The recovery rates ranged from 65.0% to 76.9% with a median time of 15-70 days.