PMID- 32841554
OWN - NLM
STAT- MEDLINE
DCOM- 20201123
LR  - 20201123
IS  - 1555-2101 (Electronic)
IS  - 0160-6689 (Linking)
VI  - 81
IP  - 5
DP  - 2020 Aug 18
TI  - Beyond 52-Week Long-Term Safety: Long-Term Outcomes of Aripiprazole Lauroxil for 
      Patients With Schizophrenia Continuing in an Extension Study.
LID - 19m12835 [pii]
LID - 10.4088/JCP.19m12835 [doi]
AB  - OBJECTIVE: To describe the long-term safety, tolerability, and symptom trajectory 
      with the long-acting injectable antipsychotic aripiprazole lauroxil (AL) in 
      patients with DSM-5-diagnosed schizophrenia followed for up to 180 weeks (3.5 
      years). METHODS: Long-term safety of 2 fixed doses of AL (441 or 882 mg every 4 
      weeks) was assessed during up to 180 weeks (3.5 years) of continuous AL exposure 
      using data from 2 sequential long-term safety studies. Safety metrics included 
      adverse events (AEs), AEs leading to study discontinuations, physical 
      examinations, laboratory parameters, and extrapyramidal symptom (EPS) rating 
      scales. Symptom trajectory was assessed in post hoc analyses using Positive and 
      Negative Syndrome Scale total (PANSST) and Clinical Global Impressions-Severity 
      of Illness scale (CGI-S) scores. RESULTS: A total of 478 patients entered the 
      52-week study and were included in the safety analysis. After the first 52 weeks, 
      safety assessments revealed no new safety concerns and were consistent with the 
      known safety profile of aripiprazole. AEs were reported by 57.5% of patients (441 
      mg, 52.7%; 882 mg, 59.0%). EPS-related AEs occurred in 12.8% of patients (441 mg, 
      9.1%; 882 mg, 13.9%). In the post hoc analysis (n = 432), least-squares mean (SE) 
      PANSST scores improved significantly from weeks 12 to 124 with AL 441 mg (-5.5 
      [0.9]) and 882 mg (-5.0 [0.5]; both P < .0001). CGI-S scores followed a similar 
      pattern of improvement. CONCLUSIONS: The AL safety profile over 180 weeks (3.5 
      years) of follow-up was consistent with prior 52-week results. Continued 
      therapeutic efficacy, based on PANSST and CGI-S scores, was observed throughout 
      the post hoc analysis period. TRIAL REGISTRATION: ClinicalTrials.gov identifier: 
      NCT01626456; ClinicalTrials.gov identifier: NCT01895452.
CI  - (c) Copyright 2020 Physicians Postgraduate Press, Inc.
FAU - Lauriello, John
AU  - Lauriello J
AD  - Department of Psychiatry and Human Behavior, Thomas Jefferson University, 833 
      Chestnut St, Ste 210, Philadelphia, PA 19107. john.lauriello@jefferson.edu.
AD  - Department of Psychiatry and Human Behavior, Thomas Jefferson University, 
      Philadelphia, Pennsylvania, USA.
FAU - Claxton, Amy
AU  - Claxton A
AD  - Alkermes, Inc, Waltham, Massachusetts, USA.
FAU - Du, Yangchun
AU  - Du Y
AD  - Alkermes, Inc, Waltham, Massachusetts, USA.
FAU - Weiden, Peter J
AU  - Weiden PJ
AD  - Alkermes, Inc, Waltham, Massachusetts, USA.
AD  - Dr Weiden is currently affiliated with Karuna Therapeutics, Inc, Boston, 
      Massachusetts.
LA  - eng
SI  - ClinicalTrials.gov/NCT01626456
SI  - ClinicalTrials.gov/NCT01895452
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20200818
PL  - United States
TA  - J Clin Psychiatry
JT  - The Journal of clinical psychiatry
JID - 7801243
RN  - 0 (Antipsychotic Agents)
RN  - 0 (Delayed-Action Preparations)
RN  - 82VFR53I78 (Aripiprazole)
RN  - B786J7A343 (aripiprazole lauroxil)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Antipsychotic Agents/administration & dosage/adverse effects/*therapeutic use
MH  - Aripiprazole/administration & dosage/adverse effects/*therapeutic use
MH  - Delayed-Action Preparations
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Psychiatric Status Rating Scales
MH  - Schizophrenia/*drug therapy
MH  - Time Factors
MH  - Treatment Outcome
MH  - Young Adult
EDAT- 2020/08/26 06:00
MHDA- 2020/11/24 06:00
CRDT- 2020/08/26 06:00
PHST- 2019/03/15 00:00 [received]
PHST- 2020/06/17 00:00 [accepted]
PHST- 2020/08/26 06:00 [entrez]
PHST- 2020/08/26 06:00 [pubmed]
PHST- 2020/11/24 06:00 [medline]
AID - 19m12835 [pii]
AID - 10.4088/JCP.19m12835 [doi]
PST - epublish
SO  - J Clin Psychiatry. 2020 Aug 18;81(5):19m12835. doi: 10.4088/JCP.19m12835.