Adverse Drug Reactions to Cancer Therapies in Patients with Depression: Insights from VigiBase

Caen University Hospital

Status: Completed

Conditions: Adverse Effects of Medical Drugs

Treatments: Drug: use of anticancer drugs in monotherapy or in combination therapy

Study type: Observational

Funder types: Other

Identifiers

NCT06801158

Pharmacol20241101

Details and patient eligibility

About

Importance:

Depression is prevalent among oncology patients and may influence the perception, reporting, and severity of adverse events (AEs) related to cancer therapies. Understanding this association is crucial for optimizing treatment outcomes and improving patient quality of life.

Objective:

To evaluate the association between depression and the reporting and severity of AEs among oncology patients using data from VigiBase®, the World Health Organization's global pharmacovigilance database.

Design:

This pharmacovigilance study employed a case/non-case disproportionality analysis using Individual Case Safety Reports (ICSRs) from 1968 to 2024. Multivariable analyses were conducted to adjust for potential confounders, such as age and sex.

Setting:

The study utilized data from VigiBase®, a global pharmacovigilance database containing reports from over 120 countries.

Participants:

ICSRs involving antineoplastic or immunomodulating agents were included. Depression was identified through antidepressant use, yielding 428,102 reports for patients on antidepressants and 8,376,761 for those not on antidepressants.

Exposure:

Oncology patients receiving antidepressant therapy were compared to those not receiving such treatment.

Main Outcome and Measures:

The primary outcome was the reporting of serious AEs (e.g., hospitalization, life-threatening events). Secondary outcomes included the 20 most frequently reported AEs among oncology patients, with comparisons made between those treated with and without antidepressants.

Enrollment: 8,804,863 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• ICSRs were limited to those involving liable antineoplastic or immunomodulating agents (per the Anatomical Therapeutic Chemical (ATC) Classification code L; hereafter referred to as antineoplastics)

Exclusion criteria

• Suspect of duplication

Trial design

8,804,863 participants in 2 patient groups

Patients with an adverse effect of interest (or with a severity criteria of that AE)

Treatment:

Drug: use of anticancer drugs in monotherapy or in combination therapy

Patients without an adverse effect of interest (or without a severity criteria of that AE)

Treatment:

Drug: use of anticancer drugs in monotherapy or in combination therapy