title: Long-term safety and effectiveness of lurasidone in schizophrenia: a 22-month, open-label extension study.
abstract: To evaluate the safety and effectiveness of lurasidone in the long-term treatment of patients with schizophrenia.
  
  
  
  Patients who completed a 6-week, double-blind (DB), placebo-controlled trial continued in a 22-month, open-label (OL) study during which they received once-daily, flexible-doses of lurasidone, 40-120 mg. Change in the Positive and Negative Syndrome Scale (PANSS) was analyzed using both observed case (OC) and last observation carried forward (LOCF) analyses.
  
  
  
  Of the 251 patients who entered the OL extension, 51.4% completed 6 months, 36.7% completed 12 months, and 26.7% completed 22 months of OL treatment. Treatment with lurasidone was associated with a mean change from DB baseline, in weight of +0.4 kg at Month 12 (n=99), and +0.8 kg at Month 24 (n=67; OC analyses). Median change from DB baseline to Month 12 and Month 24, respectively, was -1.0 and -9.0 mg/dL for total cholesterol; 0.0 and -1.0 mg/dL for LDL; +1.0 and -11.0 mg/dL for triglycerides; and 0.0 and +0.1/% for HbA1c (OC analyses). The mean PANSS total score was 96.5 at DB baseline and 69.5 at OL baseline. The mean change from DB baseline in the PANSS total score at Month 24 was -43.6 (OC) and -28.4 (LOCF). Thirty-seven patients (14.7%) discontinued due to an adverse event (AE) during OL treatment. Three AEs occurred in ≥10% of patients: schizophrenia (12.4%), akathisia (10.8%), and somnolence (10.8%); and 19.2% reported at least one movement disorder-related AE. Discontinuations due to AEs occurred in 14.8% of patients.
  
  
  
  In this 22-month, open-label extension study, treatment with lurasidone was associated with minimal effects on weight, glucose, lipids, and prolactin. Patients demonstrated sustained improvement in the PANSS total score for up to 24 months of lurasidone treatment.
authors.affiliation: 1The Zucker Hillside Hospital,Psychiatry Research,North Shore-Long Island Jewish Health System,Glen Oaks Albert Einstein College of Medicine,Bronx,New York,USA.
authors.forename: Christoph U
authors.initials: CU
authors.lastname: Correll
authors.affiliation: 2Sunovion Pharmaceuticals Inc.,Ft. Lee,New Jersey,USA.
authors.forename: Josephine
authors.initials: J
authors.lastname: Cucchiaro
authors.affiliation: 2Sunovion Pharmaceuticals Inc.,Ft. Lee,New Jersey,USA.
authors.forename: Robert
authors.initials: R
authors.lastname: Silva
authors.affiliation: 2Sunovion Pharmaceuticals Inc.,Ft. Lee,New Jersey,USA.
authors.forename: Jay
authors.initials: J
authors.lastname: Hsu
authors.affiliation: 2Sunovion Pharmaceuticals Inc.,Ft. Lee,New Jersey,USA.
authors.forename: Andrei
authors.initials: A
authors.lastname: Pikalov
authors.affiliation: 2Sunovion Pharmaceuticals Inc.,Ft. Lee,New Jersey,USA.
authors.forename: Antony
authors.initials: A
authors.lastname: Loebel
mesh_terms: D000328:Adult; D017109:Akathisia, Drug-Induced / Q000209:etiology; D014150:Antipsychotic Agents / Q000627:therapeutic use*; D001480:Basal Ganglia Diseases / Q000139:chemically induced; D002784:Cholesterol / Q000097:blood; D008078:Cholesterol, LDL / Q000097:blood; D006970:Disorders of Excessive Somnolence / Q000139:chemically induced; D050171:Dyslipidemias / Q000097:blood / Q000139:chemically induced; D005260:Female; D006442:Glycated Hemoglobin / Q000378:metabolism; D006801:Humans; D006943:Hyperglycemia / Q000139:chemically induced / Q000378:metabolism; D006966:Hyperprolactinemia / Q000139:chemically induced; D008137:Longitudinal Studies; D000069056:Lurasidone Hydrochloride / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D020734:Parkinsonian Disorders / Q000139:chemically induced; D012559:Schizophrenia / Q000188:drug therapy*; D012565:Schizophrenic Psychology; D016896:Treatment Outcome; D014280:Triglycerides / Q000097:blood; D015430:Weight Gain
chemical_list: D014150:Antipsychotic Agents; D002784:Cholesterol; D008078:Cholesterol, LDL; D006442:Glycated Hemoglobin; D000069056:Lurasidone Hydrochloride; D014280:Triglycerides; C517652:hemoglobin A1c protein, human
keywords: Atypical antipsychotic; lurasidone; maintenance treatment; safety; schizophrenia