Skip Navigation LinksHome > May 2012 - Volume 27 - Issue 3 > Long-term safety and tolerability of lurasidone in schizophr...
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International Clinical Psychopharmacology:
doi: 10.1097/YIC.0b013e32835281ef
Original Articles

Long-term safety and tolerability of lurasidone in schizophrenia: a 12-month, double-blind, active-controlled study

Citrome, Lesliea; Cucchiaro, Josephineb; Sarma, Kaushikb; Phillips, Debrab; Silva, Robertb; Tsuchiya, Satorub; Loebel, Antonyb

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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.

© 2012 Lippincott Williams & Wilkins, Inc.

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