PMID- 27574838
OWN - NLM
STAT- MEDLINE
DCOM- 20170525
LR  - 20221207
IS  - 1555-2101 (Electronic)
IS  - 0160-6689 (Linking)
VI  - 77
IP  - 11
DP  - 2016 Nov
TI  - Effect of Aripiprazole Lauroxil on Metabolic and Endocrine Profiles and Related 
      Safety Considerations Among Patients With Acute Schizophrenia.
PG  - 1519-1525
LID - 10.4088/JCP.15m10467 [doi]
AB  - 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. TRIAL REGISTRATION: ClinicalTrials.gov identifier: 
      NCT01469039.
CI  - (c) Copyright 2016 Physicians Postgraduate Press, Inc.
FAU - Nasrallah, Henry A
AU  - Nasrallah HA
AD  - Department of Neurology and Psychiatry, Saint Louis University School of 
      Medicine, 1438 S. Grand Blvd, St Louis, MO 63104. hnasral@slu.edu.
AD  - Saint Louis University School of Medicine, St Louis, Missouri, USA.
FAU - Newcomer, John W
AU  - Newcomer JW
AD  - Florida Atlantic University, Charles E. Schmidt College of Medicine, Boca Raton, 
      Florida, USA.
FAU - Risinger, Robert
AU  - Risinger R
AD  - Alkermes, Inc, Waltham, Massachusetts, USA.
FAU - Du, Yangchun
AU  - Du Y
AD  - Alkermes, Inc, Waltham, Massachusetts, USA.
FAU - Zummo, Jacqueline
AU  - Zummo J
AD  - Alkermes, Inc, Waltham, Massachusetts, USA.
FAU - Bose, Anjana
AU  - Bose A
AD  - Alkermes, Inc, Waltham, Massachusetts, USA.
FAU - Stankovic, Srdjan
AU  - Stankovic S
AD  - Alkermes, Inc, Waltham, Massachusetts, USA.
FAU - Silverman, Bernard L
AU  - Silverman BL
AD  - Alkermes, Inc, Waltham, Massachusetts, USA.
FAU - Ehrich, Elliot W
AU  - Ehrich EW
AD  - Alkermes, Inc, Waltham, Massachusetts, USA.
LA  - eng
SI  - ClinicalTrials.gov/NCT01469039
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PL  - United States
TA  - J Clin Psychiatry
JT  - The Journal of clinical psychiatry
JID - 7801243
RN  - 0 (Blood Glucose)
RN  - 0 (Delayed-Action Preparations)
RN  - 0 (Glycated Hemoglobin A)
RN  - 0 (Lipids)
RN  - 0 (Lipoproteins)
RN  - 82VFR53I78 (Aripiprazole)
RN  - 9002-62-4 (Prolactin)
RN  - B786J7A343 (aripiprazole lauroxil)
SB  - IM
MH  - Acute Disease
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Aripiprazole/*adverse effects/*therapeutic use
MH  - Blood Glucose/*metabolism
MH  - Body Weight/*drug effects
MH  - Delayed-Action Preparations
MH  - Dose-Response Relationship, Drug
MH  - Double-Blind Method
MH  - Female
MH  - Glycated Hemoglobin/*metabolism
MH  - Humans
MH  - Injections, Intramuscular
MH  - Lipids/*blood
MH  - Lipoproteins/*blood
MH  - Male
MH  - Middle Aged
MH  - Prolactin/*blood
MH  - Risk
MH  - Schizophrenia/blood/diagnosis/*drug therapy
MH  - *Schizophrenic Psychology
MH  - Young Adult
EDAT- 2016/08/31 06:00
MHDA- 2017/05/26 06:00
CRDT- 2016/08/31 06:00
PHST- 2015/10/17 00:00 [received]
PHST- 2016/03/20 00:00 [accepted]
PHST- 2016/08/31 06:00 [pubmed]
PHST- 2017/05/26 06:00 [medline]
PHST- 2016/08/31 06:00 [entrez]
AID - 10.4088/JCP.15m10467 [doi]
PST - ppublish
SO  - J Clin Psychiatry. 2016 Nov;77(11):1519-1525. doi: 10.4088/JCP.15m10467.