NCDEU Poster Session 2012

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.

Learning Objectives:
Understand the importance of maintenance therapy for preventing relapse in schizophrenia

Be knowledgeable about the relapse prevention efficacy of lurasidone and quetiapine XR

Meltzer HY, Cucchiaro J, Silva R, et al. Lurasidone in the treatment of schizophrenia: a randomized, double-blind, placebo- and olanzapine-controlled study. Am J Psychiatry. 2011;168(9):957–967. PubMed

Kishimoto T, Agarwal V, Kishi T, et al. Relapse prevention in schizophrenia: a systematic review and meta-analysis of second-generation antipsychotics versus first-generation antipsychotics [published online ahead of print November 29, 2011]. Mol Psychiatry. doi: 10.1038/mp.2011.143. PubMed

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