PMID- 35451909 OWN - NLM STAT- MEDLINE DCOM- 20221219 LR - 20221222 IS - 1744-764X (Electronic) IS - 1474-0338 (Linking) VI - 21 IP - 11 DP - 2022 Nov TI - Real-world practice patterns and characteristics of adverse events with selexipag in Korean patients with pulmonary arterial hypertension. PG - 1423-1432 LID - 10.1080/14740338.2022.2069750 [doi] AB - 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 microg/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. FAU - Chang, Sung-A AU - Chang SA AD - Division of Cardiology, Department of Medicine, Heart Vascular and Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea. FAU - Lee, Sang Hyun AU - Lee SH AD - Division of Cardiology, Department of Internal Medicine, Pusan National University Yangsan Hospital, Pusan, Republic of Korea. FAU - Choi, Jung Hyun AU - Choi JH AD - Division of Cardiology, Department of Internal Medicine, Pusan National University Hospital, Pusan, Republic of Korea. FAU - Chung, Wook-Jin AU - Chung WJ AD - Division of Cardiology, Department of Medicine, Gachon University Gil Medical Center, Incheon, Republic of Korea. FAU - Choi, Jae Young AU - Choi JY AD - Division of Pediatric Cardiology, Congenital Heart Disease Center, Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea. FAU - Kim, Hyung-Kwan AU - Kim HK AD - Division of Cardiology, Department of Internal Medicine Seoul National University College of Medicine, Section of Cardiovascular Imaging, Cardiovascular Center, Seoul National University Hospital, Seoul, Republic of Korea. FAU - Jung, Hae-Ok AU - Jung HO AD - Division of Cardiology, Department of Medicine, The Catholic University of Korea Seoul St. Mary's Hospital, Seoul, Republic of Korea. FAU - Park, Seong-Mi AU - Park SM AD - Division of Cardiology, Korea University Medicine, Anam hospital, Seoul, Republic of Korea. FAU - Kim, Won-Jang AU - Kim WJ AD - Division of Cardiology, Department of Cardiology, CHA Bundang Medical Center, CHA University School of Medicine, Republic of Korea. FAU - Jung, Su Young AU - Jung SY AD - Medical Affairs, Janssen Korea Ltd, Seoul, Republic of Korea. FAU - Chang, Hyuk-Jae AU - Chang HJ AUID- ORCID: 0000-0002-6139-7545 AD - Division of Cardiology, Severance Cardiovascular Hospital, Yonsei College of Medicine, Seoul, Republic of Korea. LA - eng PT - Journal Article PT - Multicenter Study PT - Observational Study DEP - 20220428 PL - England TA - Expert Opin Drug Saf JT - Expert opinion on drug safety JID - 101163027 RN - 5EXC0E384L (selexipag) RN - 0 (Acetamides) RN - 0 (Antihypertensive Agents) SB - IM MH - Humans MH - *Pulmonary Arterial Hypertension/chemically induced/drug therapy MH - *Hypertension, Pulmonary/drug therapy MH - Acetamides MH - Republic of Korea/epidemiology MH - Antihypertensive Agents OTO - NOTNLM OT - Adverse events OT - prescription pattern OT - pulmonary arterial hypertension OT - real-world OT - selexipag EDAT- 2022/04/23 06:00 MHDA- 2022/12/20 06:00 CRDT- 2022/04/22 12:12 PHST- 2022/04/23 06:00 [pubmed] PHST- 2022/12/20 06:00 [medline] PHST- 2022/04/22 12:12 [entrez] AID - 10.1080/14740338.2022.2069750 [doi] PST - ppublish SO - Expert Opin Drug Saf. 2022 Nov;21(11):1423-1432. doi: 10.1080/14740338.2022.2069750. Epub 2022 Apr 28.