title: Effect of Aripiprazole Lauroxil on Metabolic and Endocrine Profiles and Related Safety Considerations Among Patients With Acute Schizophrenia.
abstract: OBJECTIVE
  Aripiprazole lauroxil, a long-acting injectable antipsychotic, demonstrated safety and efficacy in treating symptoms of schizophrenia in a double-blind, placebo-controlled trial. Because the metabolic profile of antipsychotics is an important safety feature, the effects of aripiprazole lauroxil on body weight, endocrine and metabolic profiles, and safety were examined in a secondary analysis.
  
  
  METHODS
  Patients with schizophrenia (DSM-IV-TR criteria) were randomly assigned to aripiprazole lauroxil 441 mg, aripiprazole lauroxil 882 mg, or placebo intramuscularly once monthly between December 2011 and March 2014. Changes in body weight, body mass index, fasting blood glucose and serum lipids, glycosylated hemoglobin (HbA1c), and prolactin over 12 weeks were assessed. The incidence of treatment-emergent adverse events (AEs) was evaluated.
  
  
  RESULTS
  Among 622 randomized patients, no clinically relevant changes from baseline to week 12 were observed for any serum lipid, lipoprotein, plasma glucose, or HbA1c value with placebo or either dose of aripiprazole lauroxil. Both doses of aripiprazole lauroxil were associated with reductions in mean prolactin levels, whereas placebo treatment was not. The mean (standard deviation) change from baseline for body weight was 0.74 (3.9) kg, 0.86 (3.7) kg, and 0.01 (3.6) kg for aripiprazole lauroxil 441 mg, aripiprazole lauroxil 882 mg, and placebo groups, respectively. AEs related to metabolic parameters were reported in 2.4%, 1.4%, and 2.4% of patients in the aripiprazole lauroxil 441 mg, aripiprazole lauroxil 882 mg, and placebo groups, respectively.
  
  
  CONCLUSIONS
  Aripiprazole lauroxil was well tolerated, with a low-risk metabolic profile relative to published data for other antipsychotics. Changes similar to those observed with placebo were observed in the aripiprazole lauroxil groups for metabolic parameters, with modest weight gain in the active treatment groups over the 12-week course.
  
  
  BACKGROUND
  ClinicalTrials.gov identifier: NCT01469039.
authors: Department of Neurology and Psychiatry, Saint Louis University School of Medicine, 1438 S. Grand Blvd, St Louis, MO 63104. hnasral@slu.edu.|Saint Louis University School of Medicine, St Louis, Missouri, USA.
authors: Henry A
authors: HA
authors: Nasrallah
authors: Florida Atlantic University, Charles E. Schmidt College of Medicine, Boca Raton, Florida, USA.
authors: John W
authors: JW
authors: Newcomer
authors: Alkermes, Inc, Waltham, Massachusetts, USA.
authors: Robert
authors: R
authors: Risinger
authors: Alkermes, Inc, Waltham, Massachusetts, USA.
authors: Yangchun
authors: Y
authors: Du
authors: Alkermes, Inc, Waltham, Massachusetts, USA.
authors: Jacqueline
authors: J
authors: Zummo
authors: Alkermes, Inc, Waltham, Massachusetts, USA.
authors: Anjana
authors: A
authors: Bose
authors: Alkermes, Inc, Waltham, Massachusetts, USA.
authors: Srdjan
authors: S
authors: Stankovic
authors: Alkermes, Inc, Waltham, Massachusetts, USA.
authors: Bernard L
authors: BL
authors: Silverman
authors: Alkermes, Inc, Waltham, Massachusetts, USA.
authors: Elliot W
authors: EW
authors: Ehrich
mesh_terms: D000208:Acute Disease; D000293:Adolescent; D000328:Adult; D000368:Aged; D000068180:Aripiprazole / Q000009:adverse effects* / Q000627:therapeutic use*; D001786:Blood Glucose / Q000378:metabolism*; D001835:Body Weight / Q000187:drug effects*; D003692:Delayed-Action Preparations; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D006442:Glycated Hemoglobin / Q000378:metabolism*; D006801:Humans; D007273:Injections, Intramuscular; D008055:Lipids / Q000097:blood*; D008074:Lipoproteins / Q000097:blood*; D008297:Male; D008875:Middle Aged; D011388:Prolactin / Q000097:blood*; D012306:Risk; D012559:Schizophrenia / Q000097:blood / Q000175:diagnosis / Q000188:drug therapy*; D012565:Schizophrenic Psychology; D055815:Young Adult
chemical_list: D000068180:Aripiprazole; D001786:Blood Glucose; D003692:Delayed-Action Preparations; D006442:Glycated Hemoglobin; D008055:Lipids; D008074:Lipoproteins; D011388:Prolactin; C000603935:aripiprazole lauroxil