Gender differences in adverse drug reactions: knowledge synthesis and exploration

Abstract

This project was a knowledge synthesis with the aim to identify gaps in evidence and improve the understanding of gender differences in adverse drug reactions (ADRs). The following studies were conducted:* In the first study we assessed and characterized gender differences in ADRs reported to the national pharmacovigilance centre in the Netherlands while adjusting for gender differences in drug use.* In the second study we assessed whether gender differences were consistent for drug-ADR associations reported by patients/caretakers and healthcare providers (HCPs).* In the third study we assessed whether gender differences in reported ADRs for drugs commonly prescribed among patients with type 2 diabetes were consistent at different time periods of drug exposure after treatment initiation. We also explored the association between gender differences in reported ADRs and gender differences in the dose of the prescribed drug over time.* In the fourth study we assessed whether there are gender differences in drug treatment (i.e. stage of drug treatment, type of drug treatment, and drug dosing), among patients with type 2 diabetes. We also assessed whether the observed gender differences for a sample of spontaneously reported drug-ADR combinations of the first study were also reflected in ADR-like symptoms as documented in medical dossiers.* In the final study we assessed 1) whether the observed gender differences in spontaneously reported ADRs for a sample of drugs of the first study had already been described in other data sources, and 2) whether gender differences in pharmacokinetics (PK) and pharmacodynamics (PD) had been described that could explain the observed gender differences in ADRs. More details can be found in the attached file. Data was used from the following sources:* Groningen Initiative to Analyze Type 2 Diabetes Treatment (GIANTT) database: https://www.giantt.nl/nl/* Lareb Intensive Monitoring (LIM): https://www.lareb.nl/nl/image-widget/lareb-intensive-monitoring/* Lareb database of spontaneously reported adverse drug reactions: http://databank.lareb.nl/* Summary of Product Characteristics (SmPCs) and European Public Assessment Reports (EPARs): https://www.geneesmiddeleninformatiebank.nl/nl/ and https://www.ema.europa.eu/* Data from the Drug Information System of the National Health Care Institute (GIP): https://www.gipdatabank.nl