WITHDRAWN: Drugs Associated With Diabetes Insipidus- Disproportionality Analysis of Spontaneous Post-Marketing Case Reports Submitted to U.S. FDA Adverse Event Reporting System
Author(s)
ABSTRACT WITHDRAWN
OBJECTIVES:
This pharmacovigilance research study aimed to unveil the potential safety signals of Diabetes Insipidus(DI) via the Disproportionality analysis approach.METHODS:
A retrospective case/non-case study method was performed for DI signal detection using all post-marketed drugs adverse event reports submitted to the FAERS from 2000 to 2022 via openvigil 2.1 platform. Disproportionality analysis was performed using statistical tools like Proportional Reporting Ratio (PRR) and Reporting Odds Ratio (ROR). A value of PRR ≥ 2, ROR -1.96SE>1 were accounted as positive signals. Molecular gene docking was implemented to authenticate the linkage between the ligand and the protein by considering a binding affinity score of ≤ -6.RESULTS:
We retrieved a total of 894 reports including known/novel potential drugs leading to DI. Post disproportionality analysis and signal refinement, we obtained 57 drugs inducing DI with ROR>1 corresponding to 95% confidence interval (CI) supporting the correlation between the drug and the event(DI). Amongst which 10 known drugs listing desmopressin 103(75-141.6), remifentanil 87.3(52.3-145.6), thiopental 66.8(29.8-149.5), and 41 novel potential drugs namely temozolomide15.2(9.6-24), phenylephrine 12.6(5.6-28.3), and ipilimumab 12(7.5-19.1), etc., Docking results with binding affinity score of Aquaporin2 (Aqp2)gene were etoposide -9.6, bromocriptine -9.3, escitalopram -8.8 and Vasopressin 2 receptor (Avpr2) gene were Ritonavir -10.4, haloperidol -9.7, bromocriptine -9.1 respectively confirms the evidence of these drugs inducing DI.CONCLUSIONS:
In this study, we have identified potential signals like desmopressin, remifentanil, thiopental, bromocriptine, and escitalopram with the highest PRR, ROR and 95% CI representing the significant association instigating DI. As causal relationships cannot be measured from this study, detailed evaluation and validation by the scientists further are required to acknowledge the healthcare professionals regarding the possible etiological aspects of DI, prescribing patterns, and hypotheses for future studies.Conference/Value in Health Info
2022-11, ISPOR Europe 2022, Vienna, Austria
Value in Health, Volume 25, Issue 12S (December 2022)
Code
EPH116
Topic
Epidemiology & Public Health
Topic Subcategory
Safety & Pharmacoepidemiology
Disease
No Additional Disease & Conditions/Specialized Treatment Areas