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Adverse drug reactions (ADRs) are common in clinical practice, especially in patients with chronic diseases using multiple drugs. Patient characteristics, including gender, may influence the occurrence of ADRs. Gender differences can be due do to biological, physiological, social, behavioural and cultural aspects, which may influence experiencing as well as reporting of ADRs. In general, females appear to have a higher risk for ADRs than males, but current knowledge about gender differences is inconsistent and incomplete.

In this project, we aim to conduct a knowledge synthesis to identify gaps in evidence and improve our understanding of the inconsistencies in evidence. We will first conduct a systematic quantitative analysis of the spontaneously reported ADRs to the Netherlands pharmacovigilance centre Lareb to assess the extent of potential gender differences in drug-ADR associations in the Netherlands. Next, we will explore factors that may explain gender differences in ADRs (i.e. differences in pharmacokinetics/ pharmacodynamics/drug effects, differences in reporting/identifying ADRs, differences in drug exposure/use/dosing) in a case study, using oral blood glucose-lowering drugs as an example.

For this case study, we will use data from a number of sources. These include the clinical trial files available at the Dutch Medicines Evaluation Board (CBG-MEB) as well as the post-marketing data about ADRs from the spontaneously reported ADR database of Lareb and from Lareb Intensive Monitoring (LIM). LIM provides patient-reported data about ADRs for selected drugs, among which oral blood glucose-lowering drugs at several time points after initiation. Data about drug prescribing will be collected from the Genees- en hulpmiddelen Informatie Project (GIP), being made available to Lareb, and the Groningen Initiative to Analyse Type 2 diabetes Treatment (GIANTT) database.

 

This project will provide a summary of drug-ADR associations with potential relevant gender differences, and better insight in the factors that may explain such differences. The knowledge summary will be transferred to a wider audience with specific hypotheses and/or suggestions for further studies. The insight in the factors that may explain gender differences will be used to recommend specific types of pre- and post-marketing studies to increase our knowledge about gender differences in ADRs.

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