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

ABSTRACT

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.

KEYWORDS:

• Adverse events
• prescription pattern
• pulmonary arterial hypertension
• real-world
• selexipag

Acknowledgments

The authors are deeply grateful to all the participants who dedicated their time in performing this study and all participating patients. We would like to express special thanks to a study project team of Janssen Korea, Ltd.: Minseok Park for his professional contribution in protocol development, data management, and medical review, and to both SuYoun Kim and Seokyoung Choi for their valuable support on statistical analysis. We also would like to show appreciation to Editage for English language editing.

Declaration of interests

SY Jung is a full-time employee of Janssen Korea Ltd. Other authors declare no conflict of interests. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Author contributions

HJ Chang and SA Chang are the corresponding author and the first author of this article, respectively. They contributed to the conceptualization of this study and interpretation of the data. HJ Chang, SA Chang, and SY Jung analyzed data and developed the manuscript. HJ Chang, SA Chang, SH Lee, JH Choi, WJ Chung, JY Choi, HW Kim, HO Jung, SM Park, and WJ Kim collected the data and critically reviewed the manuscript. All authors contributed to and have approved the final manuscript.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Ethics approval

This is an observational study. The study received the ethical approvals from the ethics committee of each participating center. Detailed approval information are as follows: Bundang Seoul national University hospital IRB (No. B-1810-501-301; approval date: 17 October 2018), Pusan national University hospital IRB (D-1808-004-080; 4 September 2018), Eulji University hospital IRB (2018-11-001; 20 November 2018), Severance Cardiovascular Hospital IRB (2018-0672, 2018-0673; 14 August 2018), Seoul national University hospital IRB (1808-162-968; 30 August 2018), Samsung Seoul medical center IRB (2013-09-114; 17 August 2018), Korea University Anam hospital IRB (2018AN0417; 3 December 2018), Catholic University of Korea Seoul St. Mary’s Hospital IRB (KC19OODE0207; 4 April 2019), Yangsan Pusan national University hospital IRB (02-2019-012; 13 May 2019), Bundang CHA hospital IRB (CHAMC2018-09-025; 10 October 2018).

Informed consent

Written informed consent was obtained from all study participants.

Data Availability statement

The data that support the findings of this study are included in the published article. All data collected during this study are available from authors upon reasonable request and with permission of Janssen Korea, Ltd.

Additional information

Funding

This study has supported by a project grant from Janssen Korea Ltd.