Lurasidone in Schizophrenia Management: A Comprehensive 12-Week Post-Marketing Surveillance Study in Chinese Patients

Objective: To evaluate the safety and effectiveness of lurasidone in Chinese patients with schizophrenia in a 12-week post-marketing study. Methods: This 12-week, multicenter, prospective, open-label, single-arm study included schizophrenia patients from 36 sites in Mainland China, who initiated lurasidone between September 2019 and December 2023. Adverse events (AEs) and adverse drug reactions (ADRs) were primary safety endpoints. Other safety assessments included extrapyramidal symptoms (EPS) and weight gain. Effectiveness was evaluated using the Brief Psychiatric Rating Scale (BPRS) at baseline and week 12. Patients were also stratified to assess differences across ages. Results: A total of 3170 patients were included in the Full Analysis Set (FAS) and 3178 in the Safety Set (SS). The mean daily lurasidone dose was 59.9±20.93 mg. ADRs occurred in 7.9% of patients, with incidences of 8.1%, 8.9%, 5.9%, and 2.3% in the 65-year age groups, respectively. EPS was the most common ADR (3.2%), typically emerging in weeks 3-4. Metabolic-related AEs occurred in 4.3% and 2.2% of patients with and without metabolic affecting agents. BPRS scores significantly improved at weeks 2/4, 6/8, and 12 compared with baseline (all P < 0.05): total score (-8.9 ± 9.62, -14.0 ± 12.16, -17.5 ± 13.61), anxiety-depression (-1.5 ± 2.37, -2.5 ± 2.88, -3.3 ± 3.31), anergia (-1.5 ± 2.34, -2.4 ± 2.83, -3.1 ± 3.11), thought disturbance (-2.4 ± 2.98, -3.8 ± 3.72, -4.7 ± 4.07), activation (-1.2 ± 1.97, -1.7 ± 2.38, -2.1 ± 2.63), and hostility-suspiciousness (-2.4 ± 2.81, -3.6 ± 3.44, -4.3 ± 3.76). In