Performance of Stratified and Subgrouped Disproportionality Analyses in Spontaneous Databases

Seabroke, Suzie; Candore, Gianmario; Juhlin, Kristina; Quarcoo, Naashika; Wisniewski, A; Arani, Ramin B.; Painter, Jeffery L.; Tregunno, Philip M.; Norén, G. Niklas; Slattery, Jim

doi:10.1007/s40264-015-0388-3

Cited by 43 publications

(53 citation statements)

References 27 publications

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“…Moreover, the disproportionality analyses are not adjusted for factors that could influence reporting of ADR (seriousness, type of reporter i.e., health professional or not, region/country) but it is the first approach to test whether SRIs induced hypertension. Additionally, stratified analyses do not increase sensitivity or precision of analysis . Whereas depression is a condition that can influence blood pressure, our disproportionality analyses were not able to take this factor into account.…”

Section: Discussionmentioning

confidence: 91%

Hypertension induced by serotonin reuptake inhibitors: analysis of two pharmacovigilance databases

Humbert

Fédrizzi

Chrétien

et al. 2019

Fundamemntal Clinical Pharma

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Drug‐induced hypertension was described with several pharmacological classes, especially with serotonin reuptake inhibitors (SRIs). However, this link has remained controversial: the French summary of product characteristics specify a risk of hypertension only with paroxetine and sertraline. To identify a possible class effect common to all SRIs, our study investigated the reports of hypertension associated with SRIs in two pharmacovigilance databases. Two different types of investigations were performed: (i) a comparative study in VigiBase®, which is the World Health Organization (WHO) pharmacovigilance database (PVDB), from where notifications of hypertension with six SRIs (citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline) were extracted. The relationship between the suspected SRIs and the occurrence of hypertension was assessed by calculating reporting odds ratio (ROR) in a case/non‐case design; (ii) a descriptive study of hypertension reports associated with SRIs in the French pharmacovigilance database (FPVDB). In VigiBase®, 14 824 notifications of SRI‐induced hypertension (2.5%) were identified (mean age 54.3 years, mainly women 69.1%). Among them, 3 879 (26.2%) were associated to sertraline; 3 118 (21.0%) to fluoxetine; 2 725 (18.4%) to paroxetine; 2 570 (17.3%) to citalopram; 2 295 (15.5%) to escitalopram; and 237 (1.6%) to fluvoxamine. A significant ROR value was found with all six SRIs (ROR range from 1.16 to 1.92). In the FPVDB, 24 reports of hypertension were found with all six SRIs used at standard doses, mainly in women (66.7%) with a mean age of 57.8 years and a median time of onset of 6 days. In 10 cases (42%), patients had a history of hypertension. This study, performed in real conditions of life, shows a significant pharmacovigilance safety signal between the use of SRIs and the development or worsening of hypertension.

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Section: Discussionmentioning

confidence: 91%

Hypertension induced by serotonin reuptake inhibitors: analysis of two pharmacovigilance databases

Humbert

Fédrizzi

Chrétien

et al. 2019

Fundamemntal Clinical Pharma

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“…The use of the MLOSCAR subgroup approach in a cumulative spontaneous reporting database to evaluate drug‐induced SJS/TEN is, to our knowledge, a first in terms of disproportionality analysis. Our selection criteria focusing on MLOSCAR and SJS/TEN with a minimum TTO of 1 day offer some advantages: (a) shared risk factors for cases and noncases, severe cutaneous reactions, similar TTO; (b) considerable reduction in the number of noncases and an increased case/noncase ratio compared to the standard case/noncase method (limitation of the prescription bias); and (c) limitation of non‐case‐related selection bias by eliminating all ADRs manifested through skin tests and cutaneous symptoms in anaphylactic shock/reactions …”

Section: Discussionmentioning

confidence: 99%

Drug-induced Stevens-Johnson syndrome and toxic epidermal necrolysis in vietnamese spontaneous adverse drug reaction database: A subgroup approach to disproportionality analysis

et al. 2018

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“…The expected value of AE‐ROR is 1, and the AEs with corresponding lower bound of the confidence interval greater than 1 are treated as signals of disproportionate reporting in many cases. Mantel‐Haenszel correction can be used for the adjustment by stratification …”

Section: Description Of Methodsmentioning

confidence: 99%

An evaluation of statistical approaches to postmarketing surveillance

Ding

Markatou

Ball

2020

Statistics in Medicine

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Safety of medical products presents a serious concern worldwide. Surveillance systems of postmarket medical products have been established for continual monitoring of adverse events (AEs) in many countries, and the proliferation of electronic health record systems further facilitates continual monitoring for AEs. We review existing statistical methods for signal detection that are mostly in use in postmarketing safety surveillance of spontaneously reported AEs and we study their performance characteristics by simulation. We compare those with the likelihood ratio test (LRT) method (appropriately modified for use in pharmacovigilance) and use three different methods to generate data (AE based, drug based, and a modification of the method of Ahmed et al). Performance metrics include type I error, power, sensitivity, and false discovery rate, among others. The results show superior performance of the LRT method in almost all simulation experiments. An application to the FDA Adverse Event Reporting System database is illustrated using rhabdomyolysis‐related preferred terms reported to FDA during the third‐quarter of 2014 to the first‐quarter of 2017 for statin drugs. We present a critical discussion and recommendations for use of these methods.

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Performance of Stratified and Subgrouped Disproportionality Analyses in Spontaneous Databases

Abstract: Subgroup analyses perform better than stratified analyses and should be considered over the latter in routine first-pass signal detection. Subgroup analyses are also clearly beneficial over crude analyses for larger databases, but further validation is required for smaller databases.

Cited by 43 publications

References 27 publications

Hypertension induced by serotonin reuptake inhibitors: analysis of two pharmacovigilance databases

Hypertension induced by serotonin reuptake inhibitors: analysis of two pharmacovigilance databases

Drug-induced Stevens-Johnson syndrome and toxic epidermal necrolysis in vietnamese spontaneous adverse drug reaction database: A subgroup approach to disproportionality analysis

An evaluation of statistical approaches to postmarketing surveillance

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