The Use of Subgroup Disproportionality Analyses to Explore the Sensitivity of a Global Database of Individual Case Safety Reports to Known Pharmacogenomic Risk Variants Common in Japan.

ABSTRACT:

Introduction

Genetic variations of enzymes that affect the pharmacokinetics and hence effects of medications differ between ethnicities, resulting in variation in the risk of adverse drug reactions (ADR) between different populations. Previous work has demonstrated that risk-group considerations can be incorporated into approaches of statistical signal detection. It is unknown whether databases of individual case safety reports (ICSRs) are sensitive to pharmacogenomic differences between populations.

Objective

The aim of this study was to explore the sensitivity of a global database of ICSRs to known pharmacogenomic risk variants common in Japan.

Methods

The data source was VigiBase, the global database of ICSRs, including all reports entered in the version frozen on

SUBMITTER: Wakao R 

PROVIDER: S-EPMC8184560 | biostudies-literature | 2021 Jun

REPOSITORIES: biostudies-literature