title: Long-term safety and tolerability of lurasidone in schizophrenia:  a 12-month, double-blind, active-controlled study.
abstract: The aim of this study is to evaluate the long-term safety and tolerability of lurasidone in the treatment of schizophrenia. Clinically stable adult outpatients with schizophrenia were randomized in a 2 : 1 ratio to 12 months of double-blind treatment with once-daily, flexibly-dosed lurasidone (40-120 mg) or risperidone (2-6 mg). Outcome measures included adverse events (AEs), vital signs, ECG, and laboratory tests. Secondary assessments included measures of psychopathology. A total of 427 patients were randomized to treatment with lurasidone and 202 with risperidone. The three most frequent AEs in the lurasidone group (vs. risperidone) were nausea (16.7 vs. 10.9%), insomnia (15.8 vs. 13.4%), and sedation (14.6 vs. 13.9%); the three most frequent AEs in the risperidone group (vs. lurasidone) were increased weight (19.8 vs. 9.3%), somnolence (17.8 vs. 13.6%), and headache (14.9 vs. 10.0%). A higher proportion of patients receiving risperidone had at least a 7% endpoint increase in weight (14 vs. 7%). The median endpoint change in prolactin was significantly higher for risperidone (P<0.001). A comparable improvement in efficacy measures was observed with both agents and the rates of relapse were similar. All-cause discontinuation rates were higher for lurasidone versus risperidone. Long-term treatment with lurasidone was generally well tolerated in this study, with minimal effects on weight and metabolic outcomes.
authors.affiliation: Department of Psychiatry & Behavioral Sciences, New York Medical College, Valhalla, New York, USA. nntman@gmail.com
authors.forename: Leslie
authors.initials: L
authors.lastname: Citrome
authors.forename: Josephine
authors.initials: J
authors.lastname: Cucchiaro
authors.forename: Kaushik
authors.initials: K
authors.lastname: Sarma
authors.forename: Debra
authors.initials: D
authors.lastname: Phillips
authors.forename: Robert
authors.initials: R
authors.lastname: Silva
authors.forename: Satoru
authors.initials: S
authors.lastname: Tsuchiya
authors.forename: Antony
authors.initials: A
authors.lastname: Loebel
mesh_terms: D000328:Adult; D000553:Ambulatory Care; D000704:Analysis of Variance; D014150:Antipsychotic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D017523:Croatia; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D054833:Isoindoles / Q000009:adverse effects / Q000627:therapeutic use*; D007557:Israel; D053208:Kaplan-Meier Estimate; D000069056:Lurasidone Hydrochloride; D008297:Male; D008875:Middle Aged; D016016:Proportional Hazards Models; D011569:Psychiatric Status Rating Scales; D018967:Risperidone / Q000627:therapeutic use; D012559:Schizophrenia / Q000175:diagnosis / Q000188:drug therapy*; D012565:Schizophrenic Psychology; D013019:South Africa; D013020:South America; D013785:Thailand; D013844:Thiazoles / Q000009:adverse effects / Q000627:therapeutic use*; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States
chemical_list: D014150:Antipsychotic Agents; D054833:Isoindoles; D013844:Thiazoles; D018967:Risperidone; D000069056:Lurasidone Hydrochloride