Lurasidone Vs Quetiapine XR for Relapse Prevention in Schizophrenia: A 12-Month Double-Blind Study
Antony Loebel, MD; Josephine Cucchiaro, PhD; Jane Xu, PhD; Kaushik Sarma, MD; Andrei Pikalov, MD, PhD; and John M. Kane, MD
From Sunovion Pharmaceuticals, Inc, Fort Lee, New Jersey (Drs Cucchiaro, Loebel, Pikalov, Sarma, and Xu); the Department of Psychiatry, The Zucker Hillside Hospital, Glen Oaks, New York, and Hofstra North Shore-LIJ School of Medicine, Hempstead, New York (Dr Kane).
This poster presentation was supported by Sunovion Pharmaceuticals, Inc.
Objectives: To evaluate the long-term maintenance of antipsychotic efficacy of lurasidone (LUR) compared with quetiapine XR (QXR) in subjects with schizophrenia who have demonstrated clinical response to an initial 6 weeks of treatment with either LUR or QXR, as measured by the time to relapse of psychotic symptoms.
Methods: After completing an initial double-blind, placebo-controlled, 6 week trial with LUR or QXR, subjects were eligible to receive 12 months of double-blind, flexible once-daily doses of LUR (40-160 mg) vs. QXR (200-800 mg). The primary a priori efficacy comparison was between subjects treated with LUR (n=139) and QXR (n=79) who were clinical responders after acute treatment. The primary endpoint, time-to-relapse, was analyzed using a Cox proportional hazards model, with a pre-specified non-inferiority margin for the risk of relapse hazard ratio of 1.93.
Results: LUR was non-inferior to QXR in risk for relapse over the 12 month treatment period (hazard ratio 0.728, 95% CI [0.410, 1.295]). Relapse risk for LUR treated subjects was 27.2% lower than for those treated with QXR. The Kaplan-Meier estimate of the probability of relapse at 12 months was lower for LUR vs. QXR (0.237 vs. 0.336). Rates of adverse events ≥5% on LUR were akathisia (12.6%), headache (10.6%), insomnia (7.9%), anxiety (6.0%), parkinsonism (6.0%), and weight increased (6.0%). Analysis of changes from acute study baseline to 12 months of treatment (OC) with LUR and QXR, respectively, showed a mean change in weight of +0.7 vs. +1.2 kg; a median change in glucose of +1.0 vs. +1.0 mg/dL; a median change in cholesterol of 0.0 vs. +4.0 mg/dL; and a median change in triglycerides of -18.0 vs. -7.0 mg/dL.
Conclusions: This long-term, double-blind study demonstrated non-inferiority of lurasidone to QXR in prevention of relapse over a 12 month period, with a 27.2% reduction in relapse risk compared with QXR. In the current study, up to 12 months of treatment with lurasidone was found to be safe and well-tolerated, with minimal adverse effects on metabolic parameters, and a minimal effect on weight.
Understand the importance of maintenance therapy for preventing relapse in schizophrenia
Be knowledgeable about the relapse prevention efficacy of lurasidone and quetiapine XR
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