Comprehensive safety profile of dipeptidyl peptidase-4 inhibitors: a post-marketing study based on FAERS database using signal detection algorithms

Dipeptidyl peptidase-4 inhibitors (DPP-4 inhibitors) have acquired a foothold in managing type 2 diabetes mellitus, but few concerns have arisen regarding their overall safety profile. The aim of this study is to assess the potential risk of DPP-4 inhibitors by analyzing data from the FDA Adverse Ev...

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Vydané v:Expert opinion on drug safety Ročník 24; číslo 12; s. 1 - 13
Hlavní autori: Yoosuf, Beema T, Favas KT, Muhammed, Dutta, Pinaki, Bansal, Dipika
Médium: Journal Article
Jazyk:English
Vydavateľské údaje: England 23.04.2024
Predmet:
Adverse Drug Reaction Reporting Systems - statistics & numerical data
Algorithms
Data Mining
Databases, Factual
Detection Algorithms
Diabetes Mellitus, Type 2 - drug therapy
Dipeptidyl-Peptidase IV Inhibitors - administration & dosage
Dipeptidyl-Peptidase IV Inhibitors - adverse effects
Humans
Hypoglycemic Agents - administration & dosage
Hypoglycemic Agents - adverse effects
Product Surveillance, Postmarketing
Retrospective Studies
United States
United States Food and Drug Administration
United States
Dipeptidyl peptidase-4 inhibitors
type 2 diabetes mellitus
signal detection
pharmacovigilance
signal detection algorithms
ISSN:1474-0338, 1744-764X, 1744-764X
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Shrnutí:Dipeptidyl peptidase-4 inhibitors (DPP-4 inhibitors) have acquired a foothold in managing type 2 diabetes mellitus, but few concerns have arisen regarding their overall safety profile. The aim of this study is to assess the potential risk of DPP-4 inhibitors by analyzing data from the FDA Adverse Event Reporting System (FAERS) database. This is a retrospective study which explored the FAERS database till March 2023 for the collection of safety reports. The disproportionality analysis was performed using signal detection algorithms (SDAs) incorporating frequentist-based data mining approach such as relative reporting ratio (RRR), reporting odds ratio (ROR) and proportional reporting ratio (PRR) with 95% confidence interval (CI). A total of 14,573 adverse event reports were reported in the FAERS public dashboard associated with all the included DPP-4 inhibitors. The computed PRR, ROR, and RRR indicated positive signals for DPP-4 inhibitors with cardiac failure, pancreatitis, pemphigoid, hypoglycemia, acute kidney injury and lactic acidosis. Saxagliptin showed a higher signal score for cardiac failure, while sitagliptin was more associated with pancreatitis. Moreover, alogliptin exhibited an elevated signal score associated with pancreatic carcinoma. Several significant disproportionality signals were observed with DPP-4 inhibitors. However, clinicians have to consider the comorbidities and concomitant drugs while prescribing these drugs.
Bibliografia:ObjectType-Article-1
SourceType-Scholarly Journals-1
ObjectType-Feature-2
content type line 23
ISSN:1474-0338
1744-764X
1744-764X
DOI:10.1080/14740338.2024.2343015