title: Effectiveness of lurasidone vs. quetiapine XR for relapse prevention in schizophrenia: a 12-month, double-blind, noninferiority study.
abstract: OBJECTIVE
  To evaluate the relapse prevention efficacy of lurasidone compared with quetiapine XR (QXR) in adults patients with schizophrenia.
  
  
  METHODS
  This double-blind study evaluated the relapse prevention efficacy of 12 months of flexible-dose treatment with lurasidone (40-160 mg/day) compared with QXR (200-800 mg/day), in outpatients with an acute exacerbation of chronic schizophrenia who had recently completed a 6-week placebo-controlled trial of treatment with either lurasidone or QXR. The primary endpoint, time-to-relapse, was analyzed using a Cox proportional hazards model in this noninferiority trial.
  
  
  RESULTS
  The Kaplan-Meier estimate of the probability of relapse over 12 months was 23.7% for subjects receiving lurasidone vs. 33.6% for QXR. The hazard ratio [95% CI] for probability of relapse was 0.728 [0.410, 1.295] (log-rank p=0.280). Since the upper limit of the hazard ratio (1.295) was smaller than the prespecified noninferiority margin (1.93), noninferiority of lurasidone compared with QXR was demonstrated in this study. The probability of hospitalization at 12 months was lower for the lurasidone group compared with the QXR group (9.8% vs. 23.1%; log-rank p=0.049). A significantly higher proportion of lurasidone subjects achieved remission at study endpoint compared with the QXR group (61.9% vs. 46.3%; p=0.043). Discontinuation rates due to AEs were similar for lurasidone and QXR (7% vs. 5%). Treatment with lurasidone was not associated with clinically significant changes in weight or metabolic parameters.
  
  
  CONCLUSIONS
  Twelve months of treatment with lurasidone met noninferiority criteria, and was associated with higher rates of remission, and reduced risk of hospitalization compared with QXR. No clinically significant effects on weight or metabolic parameters were observed during maintenance treatment with lurasidone.
authors.affiliation: Sunovion Pharmaceuticals Inc., Ft. Lee, NJ, United States. Electronic address: antony.loebel@sunovion.com.
authors.forename: Antony
authors.initials: A
authors.lastname: Loebel
authors.affiliation: Sunovion Pharmaceuticals Inc., Ft. Lee, NJ, United States.
authors.forename: Josephine
authors.initials: J
authors.lastname: Cucchiaro
authors.affiliation: Sunovion Pharmaceuticals Inc., Ft. Lee, NJ, United States.
authors.forename: Jane
authors.initials: J
authors.lastname: Xu
authors.affiliation: Sunovion Pharmaceuticals Inc., Ft. Lee, NJ, United States.
authors.forename: Kaushik
authors.initials: K
authors.lastname: Sarma
authors.affiliation: Sunovion Pharmaceuticals Inc., Ft. Lee, NJ, United States.
authors.forename: Andrei
authors.initials: A
authors.lastname: Pikalov
authors.affiliation: Department of Psychiatry, The Zucker Hillside Hospital, Glen Oaks, NY, United States; Hofstra North Shore-LIJ School of Medicine, United States.
authors.forename: John M
authors.initials: JM
authors.lastname: Kane
mesh_terms: D000328:Adult; D014150:Antipsychotic Agents / Q000627:therapeutic use*; D003987:Dibenzothiazepines / Q000627:therapeutic use*; D004311:Double-Blind Method; D004562:Electrocardiography; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D054833:Isoindoles / Q000627:therapeutic use*; D053208:Kaplan-Meier Estimate; D000069056:Lurasidone Hydrochloride; D008297:Male; D008875:Middle Aged; D011569:Psychiatric Status Rating Scales; D000069348:Quetiapine Fumarate; D012559:Schizophrenia / Q000188:drug therapy*; D055502:Secondary Prevention; D013844:Thiazoles / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D014150:Antipsychotic Agents; D003987:Dibenzothiazepines; D054833:Isoindoles; D013844:Thiazoles; D000069348:Quetiapine Fumarate; D000069056:Lurasidone Hydrochloride