Work

Safety of Vortioxetine in Patients With Depression: A Post‐Marketing Surveillance Study of Intracranial Hemorrhage in a Japanese Health Insurance Claims Database

Year: 2025

Type: article

Abstract: AIM: As part of a post-marketing commitment, this study evaluated the incidences of intracranial hemorrhage and serious (intracranial or gastrointestinal) hemorrhage requiring hospitalization in Japanese patients with depression prescribed vortioxetine or selective serotonin reuptake inhibitors (SSRIs). METHODS: This real-world, retrospective cohort study used data from the JMDC claims database. Patients with depression who received an initial prescription for vortioxetine or SSRIs (index date) between November 2019 and November 2022, with an observation period of 6 months before (look-back period) and up to 360 days after (follow-up period) the index date were included. The primary analysis estimated the incidence of intracranial hemorrhage, while the secondary analysis estimated the incidence of serious hemorrhage requiring hospitalization. A multivariate model incorporating age, sex, antithrombotic and nonsteroidal anti-inflammatory drug prescriptions, and hypertension as covariates was used to calculate adjusted hazard ratios (aHRs). A propensity score incorporating 21 additional covariates assessed the robustness of the primary analysis (sensitivity analysis). RESULTS: Overall, 147 777 patients were included; 22 827 were prescribed vortioxetine (exposure) and 124 950 were prescribed SSRIs (control). The incidence of intracranial hemorrhage was 1.5 per 10 000 person-years in the exposure group and 3.2 per 10 000 person-years in the control group (aHR: 0.5, 95% confidence interval [CI]: 0.1-1.9). The incidence of serious hemorrhage requiring hospitalization was 27.4 per 10 000 person-years in the exposure group and 31.4 per 10 000 person-years in the control group (aHR: 0.8, 95% CI: 0.6-1.2). The incidence of intracranial hemorrhage in the exposure group versus the control group in the sensitivity analysis was similar to the primary analysis (aHR: 0.4, 95% CI: 0.1-1.9). CONCLUSION: The incidence of intracranial hemorrhage and serious hemorrhage requiring hospitalization was low in Japanese patients with depression prescribed vortioxetine, and comparable with that observed in patients prescribed SSRIs. TRIAL REGISTRATION: ClinicalTrials.gov: NCT05932407.

Source: Neuropsychopharmacology Reports

DOI: 10.1002/npr2.70077

Authors: Takeshi Inoue, Rie Otake, Tatsuya Hoshino

Institutions: Tokyo Medical University, Hanazono Hospital, Takeda (Japan)

Language: English

Topic: Pharmacovigilance and Adverse Drug Reactions

Subfield: Toxicology

Field: Pharmacology, Toxicology and Pharmaceutics

Domain: Life Sciences

SDG: Good health and well-being

Open Access status: gold

Estimated APC paid: $2,500