PMID- 33191903
OWN - NLM
STAT- MEDLINE
DCOM- 20210414
LR  - 20221207
IS  - 0946-1965 (Print)
IS  - 0946-1965 (Linking)
VI  - 59
IP  - 3
DP  - 2021 Mar
TI  - Disproportionality analysis of spontaneously reported hypoglycemia events due to 
      insulin use: A comparison between insulin detemir and insulin degludec using the 
      Korea Adverse Event Reporting System.
PG  - 224-230
LID - 10.5414/CP203768 [doi]
AB  - OBJECTIVE: This study aimed to compare the rate of hypoglycemic events from all 
      spontaneously reported adverse events (AEs) between insulin detemir and insulin 
      degludec using the Korea Adverse Event Reporting System (KAERS) database. 
      MATERIALS AND METHODS: We analyzed data on the reported hypoglycemia events 
      retrieved from adverse drug reactions (ADR) on the use of different insulin types 
      from 2016 to 2017 in the Korea Institute of Drug Safety & Risk Management-Korea 
      Adverse Event Reporting System Database (KIDS-KD). After defining hypoglycemic 
      events as the AE of interest, we performed a disproportionality analysis by 
      calculating the reporting odds ratio (ROR) to identify the disproportionality of 
      AEs following treatment with insulin degludec (IDeg) and insulin detemir (IDet). 
      Because spontaneously reported hypoglycemic events were not distinguished between 
      insulin glargine 100 U/mL (Gla-100) and insulin glargine 300 U/mL (Gla-300) due 
      to same ATC code by KIDS-KD, direct comparisons of Gla-100 and Gla-300 or 
      comparisons of each analog of insulin glargine vs. IDet or IDeg, respectively, 
      could not be achieved. RESULTS: Of the 3,220 AEs caused by the use of long-acting 
      basal insulin, 739 and 296 were caused by IDeg and IDet, respectively. Among 
      these, 172 (23.3%) of the 739 and 83 (28.0%) of the 296 AEs were reported to be 
      hypoglycemic events caused by IDeg and IDet, respectively. The rate of reported 
      hypoglycemic events caused by IDeg was lower than that of IDet (ROR (95% CI): 
      0.78 (0.71 - 0.86)). Further, IDeg consistently caused lower hypoglycemia events 
      than IDet in the sensitivity analysis (ROR (95% CI): 0.41 (0.37 - 0.46)). 
      CONCLUSION: When we compared the proportionality of hypoglycemic events among the 
      total number of reported AEs for each of the two basal insulins through 
      disproportionality analysis using the spontaneous ADR reporting system, IDeg 
      showed a relatively lower rate of reported hypoglycemic events than IDet.
FAU - Jeong, DaWo
AU  - Jeong D
FAU - Kim, Won
AU  - Kim W
FAU - Shin, Ju-Young
AU  - Shin JY
LA  - eng
PT  - Journal Article
PL  - Germany
TA  - Int J Clin Pharmacol Ther
JT  - International journal of clinical pharmacology and therapeutics
JID - 9423309
RN  - 0 (Blood Glucose)
RN  - 0 (Glycated Hemoglobin A)
RN  - 0 (Hypoglycemic Agents)
RN  - 0 (Insulin, Long-Acting)
RN  - 2ZM8CX04RZ (Insulin Glargine)
RN  - 4FT78T86XV (Insulin Detemir)
RN  - 54Q18076QB (insulin degludec)
SB  - IM
MH  - Blood Glucose
MH  - *Diabetes Mellitus, Type 2
MH  - Glycated Hemoglobin/analysis
MH  - Humans
MH  - *Hypoglycemia/chemically induced/epidemiology
MH  - Hypoglycemic Agents/adverse effects
MH  - Insulin Detemir/adverse effects
MH  - Insulin Glargine/adverse effects
MH  - Insulin, Long-Acting
MH  - Republic of Korea/epidemiology
EDAT- 2020/11/17 06:00
MHDA- 2021/04/15 06:00
CRDT- 2020/11/16 08:42
PHST- 2021/02/11 00:00 [accepted]
PHST- 2020/11/17 06:00 [pubmed]
PHST- 2021/04/15 06:00 [medline]
PHST- 2020/11/16 08:42 [entrez]
AID - 187449 [pii]
AID - 10.5414/CP203768 [doi]
PST - ppublish
SO  - Int J Clin Pharmacol Ther. 2021 Mar;59(3):224-230. doi: 10.5414/CP203768.