DOI: 10.6084/m9.figshare.29091921.v2
title: Vortioxetine in the routine management of major depressive disorder: an analysis of European automated healthcare databases

description: Vortioxetine is a multimodal antidepressant approved for the treatment of major depressive episodes. As part of the overall European risk-management plan, we aimed to fill data gaps on relevant missing information such as the extent of vortioxetine use in special populations and assessment of selected potential risks. This non-interventional post-authorization safety study used longitudinal administrative claims/medical records data from 10,358 patients newly prescribed vortioxetine in Finland, Spain, and the Netherlands (EU-PAS register: EUPAS19199). Elderly patients (≥75 years) accounted for 3–14% of the assessed populations, while off-label pediatric prescribing was low (0.1–0.5%). Patients with a comorbid diagnosis of mania/hypomania accounted for 0.4–10% of the population, while patients with comorbid neurological conditions accounted for ≤3% of patients. The median prescribed daily vortioxetine dose was 10 mg and mean exposure was 72–238 days. The proportions of patients who had one of the events of interest (suicidal events, epilepsy, convulsions/seizures, severe renal or hepatic events) recorded during vortioxetine exposure were all ≤1%. In this European healthcare database study, the extent and characteristics of vortioxetine use were in line with clinical trial experience and the current label. Analyses of events, including those of special interest, did not raise any new safety concerns. For people with major depressive disorder (MDD), it is crucial that antidepressant treatments, like vortioxetine, are safe and well-tolerated to ensure patients stick with their medication and achieve successful treatment outcomes. The European Medicines Authority often requires drug manufacturers to evaluate potential risks once a drug is in regular use. This evaluation, known as a “risk management plan”, looks at how the drug is used in everyday practice and assesses its safety, especially in vulnerable patients. As part of the European Vortioxetine Risk Management Plan, researchers used health data from Finland, Spain, and the Netherlands to: 1.Understand how vortioxetine is being used in patients who were not included in earlier clinical trials. This includes elderly people, children, stroke survivors, pregnant women, and those living with other long-term conditions like mania/hypomania, Alzheimer’s disease, Parkinson’s disease, multiple sclerosis, and severe kidney or liver problems. 2.Look for rare safety risks such as suicide, seizures, kidney or liver side-effects, and the potential for drug abuse. The study analyzed data from over 10,000 patients treated with vortioxetine. It found that vortioxetine was generally used as recommended in the European prescribing guidelines, with an average daily dose of 10 mg in all three countries. Depression treatment guidelines recommend long-term use of antidepressants for at least 6–12 months to prevent relapse, and the study confirmed that vortioxetine is typically used for about 7–8 months on average. The analysis did not reveal any new safety concerns, supporting the established safety profile of vortioxetine.