Korean J Clin Pharm.  2024 Jun;34(2):100-107. 10.24304/kjcp.2024.34.2.100.

Signal Detection of DPP-IV Inhibitors using Spontaneous Adverse Event Reporting System in Korea

• Pyo H
• Kim TY
• Choi SB
• Jo HJ
• Kang HL
• Kim JS
• Gwak HS
• Han JM

• KMID: 2564364
• DOI: http://doi.org/10.24304/kjcp.2024.34.2.100

Abstract

Background
The purpose of this study was to detect signals of adverse events (AEs) of DPP-IV inhibitors using the KIDs-Korea Adverse Event Reporting System (KAERS) database.
Methods
This study was conducted using AEs reported from January 2009 to December 2018 in the KIDs-KAERS database. For signal detection, disproportionality analysis was performed. Signals of DPPIV inhibitor that satisfied the data-mining indices of reporting odds ratio (ROR) were detected.
Results
Among the total number of 10,364 AEs to all oral hypoglycemic agents, the number of reported AEs related to DPP-IV inhibitors was 1,674. Analysis of re- ported AEs of DPP-IV inhibitors at the SOC levels showed that Respiratory system disorders were the highest at 4.31 (95% CI 3.01-6.17), followed by Skin and appendages disorders at 2.04 (95% CI 1.74-2.38). When analyzing AEs reported at the PT level, phar-yngitis was the highest at 73.90 (95% CI 17.59-310.49), followed by arthralgia at 6.08 (95% CI 2.04-18.11), and coughing at 5.21 (95% CI 2.07-13.15).
Conclusions
Based on the result of the study, deeper consideration is required according to the characteristics of the patients in prescribing DPP-IV inhibitors among oral hypoglycemic agents, and continuous monitoring of the occurrence of related Adverse Drug Reactions during administration is also required.

Keyword

Adverse event; data mining; dpp-IV inhibitor; Korea adverse event reporting system