Active-comparator restricted disproportionality analysis for pharmacovigilance signal detection studies of chronic disease medications: An example using sodium/glucose cotransporter 2 inhibitors.
Humans
Diabetes Mellitus, Type 2
/ drug therapy
Pharmacovigilance
Dipeptidyl-Peptidase IV Inhibitors
/ therapeutic use
Diabetic Ketoacidosis
/ chemically induced
Adverse Drug Reaction Reporting Systems
Sodium-Glucose Transporter 2 Inhibitors
/ adverse effects
Chronic Disease
Acute Kidney Injury
/ chemically induced
Glucose
Sodium
active comparator, disproportionality analysis, pharmacovigilance, restriction, safety signal, SGLT2 inhibitors
Journal
British journal of clinical pharmacology
ISSN: 1365-2125
Titre abrégé: Br J Clin Pharmacol
Pays: England
ID NLM: 7503323
Informations de publication
Date de publication:
02 2023
02 2023
Historique:
revised:
25
11
2021
received:
05
10
2021
accepted:
03
12
2021
pubmed:
30
12
2021
medline:
18
1
2023
entrez:
29
12
2021
Statut:
ppublish
Résumé
Disproportionality analysis is a common pharmacovigilance tool to detect safety signals of type 2 diabetes medications from spontaneous drug reporting databases. The aim was to demonstrate the impact of using active-comparator restricted disproportionality analysis (ACR-DA), wherein the reference group is restricted to reports with a clinically appropriate active comparator. Using reports from the Food and Drug Administration Adverse Event Reporting System, we assessed if sodium/glucose cotransporter 2 (SGLT2) inhibitors are associated with higher reporting of 5 potential adverse events: acute kidney injury, genitourinary tract infections, diabetic ketoacidosis, fractures, and amputations. For each adverse event, we calculated the proportional reporting ratio (PRR) and adjusted reporting odds ratio (aROR [95% confidence interval, CI]) using 3 types of reference groups: no SGLT2 inhibitor (background risk reference), other diabetes drugs (therapeutic class reference), and dipeptidyl peptidase 4 inhibitors (active comparator reference). Based on ACR-DA, we did not detect a safety signal for acute kidney injury (PRR 0.92 [0.81-1.04]; aROR 0.78 [95% CI 0.72-0.85]) or fractures (PRR 0.44[95% CI 0.17-1.15]; aROR 0.74 [95% CI 0.61-0.91]) associated with SGLT2 inhibitors compared to dipeptidyl peptidase 4 inhibitors. However, we detected safety signals for genitourinary tract infections (PRR 2.75[2.02-3.76]; aROR 2.54[2.26-2.86], diabetic ketoacidosis (PRR 63.85[39.37-103.53; aROR 91.49[70.66-118.48]), and amputations (PRR 52.60 [19.66-140.75]; aROR 22.64 [15.32-33.42]. The use of the proposed ACR-DA to detect safety signals of type 2 diabetes medications may reduce false positive safety signals through careful selection of the comparator which is expected to reduce channelling bias.
Substances chimiques
Dipeptidyl-Peptidase IV Inhibitors
0
Sodium-Glucose Transporter 2 Inhibitors
0
Glucose
IY9XDZ35W2
Sodium
9NEZ333N27
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
431-439Informations de copyright
© 2021 British Pharmacological Society.
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