Vortioxetine in the routine management of major depressive disorder: an analysis of European automated healthcare databases.

Abstract

Objective: 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.

Methods: 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).

Results: 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%.

Conclusion: 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.