PMID- 30666842
OWN - NLM
STAT- MEDLINE
DCOM- 20190225
LR  - 20200225
IS  - 1976-2437 (Electronic)
IS  - 0513-5796 (Print)
IS  - 0513-5796 (Linking)
VI  - 60
IP  - 2
DP  - 2019 Feb
TI  - Signal Detection for Cardiovascular Adverse Events of DPP-4 Inhibitors Using the 
      Korea Adverse Event Reporting System Database, 2008-2016.
PG  - 200-207
LID - 10.3349/ymj.2019.60.2.200 [doi]
AB  - PURPOSE: Cardiovascular adverse events (AEs) after use of dipeptidyl peptidase-4 
      (DPP4) inhibitors have been reported and suspected since the launch of DPP-4 
      inhibitors in 2006. However, few studies have investigated the association 
      between cardiovascular AEs and DPP-4 inhibitors. The objective of this study is 
      to detect the signals of cardiovascular AEs after use of DPP-4 inhibitors by 
      analyzing the Korea Institute of Drug Safety & Risk Management-Korea Adverse 
      Event Reporting System Database (KIDS-KD). MATERIALS AND METHODS: Data on the use 
      of oral antidiabetic drugs from 2008 to 2016 were extracted from KIDS-KD, and 
      analyzed descriptively. Data mining was conducted by calculating three indices, 
      which were proportional reporting ratios, reporting odds ratios, and information 
      components, to detect signals from use of all oral antidiabetic drugs including 
      DPP-4 inhibitors. Then, the suspected adverse drug reactions (ADRs) were 
      confirmed by signal detection, and drug label information between the Korea 
      Ministry of Food and Drug Safety and the U.S. Food and Drug Administration were 
      compared. RESULTS: Cardiovascular AEs after taking DPP-4 inhibitors were detected 
      in only three (1.0%) out of a total of 307 AE reports. Two of the three 
      cardiovascular AEs were reported after using sitagliptin and one using 
      gemiglipitin, but these were not statistically significant. CONCLUSION: Analysis 
      of spontaneous ADR reports data on the use of DPP-4 inhibitors could not showed 
      the association between DPP-4 inhibitors and cardiovascular AEs, due to a small 
      number of cardiovascular AEs reports.
CI  - (c) Copyright: Yonsei University College of Medicine 2019.
FAU - Yi, Hyemin
AU  - Yi H
AUID- ORCID: 0000-0001-6673-0442
AD  - School of Pharmacy, Sungkyunkwan University, Suwon, Korea.
FAU - Lee, Ji Ho
AU  - Lee JH
AUID- ORCID: 0000-0002-2230-131X
AD  - School of Pharmacy, Sungkyunkwan University, Suwon, Korea.
AD  - National Institute of Food and Drug Safety Evaluation, Korea Ministry of Food and 
      Drug Safety, Cheongju, Korea.
FAU - Shin, Ju Young
AU  - Shin JY
AUID- ORCID: 0000-0002-2791-1037
AD  - School of Pharmacy, Sungkyunkwan University, Suwon, Korea. shin.jy@skku.edu.
LA  - eng
GR  - NRF-2017R1C1B5017907/National Research Foundation of Korea/
PT  - Journal Article
PL  - Korea (South)
TA  - Yonsei Med J
JT  - Yonsei medical journal
JID - 0414003
RN  - 0 (Dipeptidyl-Peptidase IV Inhibitors)
RN  - 0 (Hypoglycemic Agents)
SB  - IM
MH  - Administration, Oral
MH  - Adolescent
MH  - Adult
MH  - *Adverse Drug Reaction Reporting Systems
MH  - Aged
MH  - Cardiovascular Diseases/*chemically induced
MH  - Child
MH  - Data Mining
MH  - Databases, Factual
MH  - Dipeptidyl-Peptidase IV Inhibitors/administration & dosage/*adverse effects
MH  - Drug Labeling
MH  - Female
MH  - Humans
MH  - Hypoglycemic Agents/administration & dosage/adverse effects
MH  - Male
MH  - Middle Aged
MH  - Odds Ratio
MH  - Republic of Korea
MH  - United States
MH  - United States Food and Drug Administration
MH  - Young Adult
PMC - PMC6342716
OTO - NOTNLM
OT  - DPP-4 inhibitor
OT  - KIDS KAERS database
OT  - cardiovascular disease
OT  - pharmacovigilance
OT  - signal
COIS- The authors have no potential conflicts of interest to disclose.
EDAT- 2019/01/23 06:00
MHDA- 2019/02/26 06:00
PMCR- 2019/02/01
CRDT- 2019/01/23 06:00
PHST- 2018/08/07 00:00 [received]
PHST- 2018/11/18 00:00 [revised]
PHST- 2018/12/20 00:00 [accepted]
PHST- 2019/01/23 06:00 [entrez]
PHST- 2019/01/23 06:00 [pubmed]
PHST- 2019/02/26 06:00 [medline]
PHST- 2019/02/01 00:00 [pmc-release]
AID - 60.200 [pii]
AID - 10.3349/ymj.2019.60.2.200 [doi]
PST - ppublish
SO  - Yonsei Med J. 2019 Feb;60(2):200-207. doi: 10.3349/ymj.2019.60.2.200.