Time‐to‐onset analysis of amiodarone‐associated thyroid dysfunction

Abstract

What is known and objective: Amiodarone (AMD) treatment is associated with a number of significant adverse effects including thyroid dysfunction. However, the relationship between the development of thyroid dysfunction and the dosage and treatment duration of AMD remains unclear. The purpose of this study was to examine the onset profiles of amiodarone-associated thyroid dysfunction using a spontaneous adverse drug reaction (ADR) reporting database. Methods: Data were obtained from the US Food and Drug Administration Adverse Event Reporting System (FAERS). For signal detection of spontaneous ADRs, the reporting odds ratio (ROR) and information component (IC) were calculated. Cumulative incidences of hyperthyroidism and hypothyroidism were assessed using the Kaplan-Meier method, and time-to-onset profiles were analysed using the Weibull shape parameter (WSP) test. Results and discussion: The median time-to-onset of hyperthyroidism associated with AMD and other drugs was 720.

2023 ACC/AHA/ACCP/HRS Guideline for the Diagnosis and Management of Atrial Fibrillation: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines

“…1 In 1 study, the median time to onset of amiodarone-induced hypothyroidism was 183 days, with a median onset of hyperthyroidism of 720 days. 2 Oral amiodarone may also provoke elevations in hepatic transaminases and, rarely, hepatotoxicity. 3…”

Neurological Adverse Events Associated With Esketamine: A Disproportionality Analysis for Signal Detection Leveraging the FDA Adverse Event Reporting System

“…Analyses of TTO data were performed based on median duration, quartiles, and the Weibull shape parameter (WSP) test (Mazhar et al, 2021), which is used to determine the varying rate of incidence of AEs (Mazhar et al, 2021). The scale parameter α and shape parameter β are used to describe the Weibull distribution (Kinoshita et al, 2020;Mazhar et al, 2021). We calculated the median TTO and WSP of signals with moderate or strong clinical priority after the beginning of the esketamine therapy in order to predict the hazard of the occurrence of these AEs over time.…”

“…We calculated the median TTO and WSP of signals with moderate or strong clinical priority after the beginning of the esketamine therapy in order to predict the hazard of the occurrence of these AEs over time. The selection of parameters and criteria for evaluation were described in previous studies (Kinoshita et al, 2020;Mazhar et al, 2021). All WSP tests were conducted using Minitab statistical software (v19.1.0; Minitab LLC, State College, PA, United States).…”

Gastrointestinal adverse events associated with semaglutide: A pharmacovigilance study based on FDA adverse event reporting system

“…In order to ensure the accuracy of this calculation, reports with input errors (EVENT_DT earlier than START_DT), inaccurate date entries and missing specific data were excluded. The medians, quartiles and the Weibull shape parameter (WSP) test were used to evaluate the TTO in our study ( 21 , 22 ). The TTO statistical analysis was conducted using the WSP test, which could determine the varying ratio of incidence of AEs.…”

“…In order to predict the risk of increase or decrease of these AEs over time, we calculated the median TTO and WSP of signals with strong, moderate or weak clinical priority after semaglutide use. The selection of parameters and criteria for evaluation were described in previous studies ( 21 , 22 ). All WSP tests were performed by Minitab statistical software (v20.0; Minitab LLC, State College, PA, United States).…”