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Psych Congress  

Switching to Lurasidone in Patients With Schizophrenia: Tolerability and Effectiveness at 6 Weeks and 6 Months

Authors  
Andrei Pikalov, MD, PhD. Joseph McEvoy, MD. Leslie Citrome, MD, MPH. Jay Hsu, PhD. Peter Werner, PhD. Andrei Pikalov, MD, PhD. Josephine Cucchiaro, PhD. Christoph Correll, MD. Antony Loebel, MD.
Sponsor  
Sunovion Pharmaceuticals Inc.

Objectives: To evaluate the safety, tolerability and effectiveness of switching clinically stable outpatients with schizophrenia or schizoaffective disorder to lurasidone.
Methods: Non-acute patients with schizophrenia or schizoaffective disorder who were candidates for switching from a current antipsychotic were randomized to three 6-week, open-label lurasidone switch strategies: a 40/40 group (N=74) started on 40 mg/d for 14 days; a 40/80 group (N=88) started on 40 mg/d for 7 days, then increased to 80 mg/d for 7 days; and an 80/80 group (N=82) with 80 mg/d for 14 days. All patients were then treated for 4 weeks with lurasidone (40-120 mg/d); completers were eligible for a 6 month extension study. Time to treatment failure was evaluated as the primary outcome. 
Results: 86.5% of patients completed the 6-week study and 65.8% of patients completed the extension study. Discontinuation due to AEs was 7.0% in the core 6 week study and 11.4% during the extension study. No clinically relevant differences in safety, tolerability or efficacy were noted when comparing the 3 switch strategies. Time to treatment failure was similar between three lurasidone dosing strategies. Improvement in the PANSS total score was observed in the 6 week study (-5.3; LOCF-endpoint) and in the 6 month study (-1.5; LOCF-endpoint). Minimal changes were observed in weight, lipid and glycemic indices in both the core and extension studies. 
Conclusion: Switching to lurasidone was well-tolerated regardless of initial dose or rate of titration. At the end of 6 months, minimal changes were observed in weight and lipid parameters.  

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