Journal
INTERNATIONAL CLINICAL PSYCHOPHARMACOLOGY
Volume 27, Issue 3, Pages 165-176Publisher
LIPPINCOTT WILLIAMS & WILKINS
DOI: 10.1097/YIC.0b013e32835281ef
Keywords
double-blind; lurasidone; risperidone; safety; schizophrenia
Categories
Funding
- Sunovion Pharmaceuticals Inc.
- Alexza
- Alkermes
- AstraZeneca
- Bristol-Myers Squibb
- Eli Lilly
- Janssen
- Lundbeck
- Merck
- Novartis
- Noven
- Otsuka
- Pfizer
- Shire
- Sunovion
- Valeant
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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. Int Clin Psychopharmacol 27:165-176 (C) 2012 Wolters Kluwer Health vertical bar Lippincott Williams & Wilkins.
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