(236) Signal Detection for Adverse Events of Dapagliflozin Using the Korea Adverse Event Reporting System Database

Sunday, August 28, 2022

8:00 AM – 1:45 PM CEST

Location: Hall C

Publication Number: 1281

Presenting Author(s)

Suvin Park
– Ewha Womans University, Seodaemun-gu, South Korea

Co-Author(s)

Huieon Lee
– Seodaemun-gu, South Korea
Heejin Kim
– Ewha Womans University, Seodaemungu, South Korea
Na-Young Jeong
– Ewha Womans University, Seodaemungu, Gyeonggido, South Korea
EUNSUN LIM
– Seodaemun-gu, South Korea
Nam-Kyong Choi
– Department of Health Convergence, College of Science & Industry Convergence, Ewha Womans University, Seoul, Republic of Korea, Republic of Korea

Background: Dapagliflozin, which launched in Korea in 2013, is Sodium–glucose cotransporter 2 (SGLT2) inhibitors and its indications and use is expanding. However, safety studies using spontaneous adverse event reporting database for dapagliflozin are insufficient in Korea.

Objectives: We aimed to detect potential signals for dapagliflozin using the KAERS database.

Methods: We identified adverse events (AEs) reports related to non–insulin anti–hyperglycaemics (ATC code A10B) in the KAERS from 2014 to 2020. The drug of interest was dapagliflozin (ATC code A10BK01) that were conducted post–marketing safety surveillance in the United States (US) and Europe and recently finished re–examination in Korea. We applied disproportionality analysis to detect safety signals and calculated the proportional reporting ratio (PRR), reporting odds ratio (ROR), and information component (IC). All detected signals were reviewed to determine whether these signals corresponded to known AEs from drug labels in Korea. Additionally, US Food and Drug Administration (FDA) drug labels and risk management plan from European Medicines Agency (EMA) were reviewed to collect data of significant AEs of dapagliflozin and compare with detected signals.

Results: We identified 1,871 reports related to dapagliflozin and 17,681 reports related to other non-insulin anti-hyperglycaemics from 2014 to 2020. More than half of the reports related to dapagliflozin were from female (1,209, 64.62%) and aged of 40 to 64 (1,317, 70.39%). A total of 81,712 total drug-AE pairs, 2,562 pairs of dapagliflozin-AEs were included in the analysis. Of the 38 detected signals, four AEs including SGOT increased, azotaemia, hypotonia, and increased stool frequency were not listed on the Korea drug label. The four AEs were also not included in the AEs specified in the FDA drug label and RMP from EMA.

Conclusions: Among 38 detected signals in this study, four AEs were not contained in the current safety information in the US, Europe, and Korea. Since the dapagliflozin had been introduced recently in Korea, the reported data could not be enough, so further analyses are needed using accumulated data.