PMID- 18334908
OWN - NLM
STAT- MEDLINE
DCOM- 20080626
LR  - 20220321
IS  - 0271-0749 (Print)
IS  - 0271-0749 (Linking)
VI  - 28
IP  - 2 Suppl 1
DP  - 2008 Apr
TI  - Safety profile of iloperidone: a pooled analysis of 6-week acute-phase pivotal 
      trials.
PG  - S12-9
LID - 10.1097/JCP.0b013e3181694f5a [doi]
AB  - Iloperidone, a mixed D2/5-HT2 antagonist, is currently in clinical development 
      for the treatment of schizophrenia. This article assesses the short-term safety 
      of iloperidone using a pooled analysis of 3 phase 2, short-term acute 
      schizophrenia studies conducted between 1998 and 2002 (N = 1943). Patients 
      exposed to 3 dose ranges of iloperidone, another antipsychotic, or placebo were 
      compared on rates of serious adverse events (SAEs), adverse events (AEs), 
      extrapyramidal symptoms, akathisia, prolactin, weight and metabolic parameters, 
      QTc, and other standard safety parameters. The most common treatment-related AEs 
      observed with iloperidone were dizziness, headache, dry mouth, nausea, and 
      insomnia. Discontinuation due to AEs was 4.8% for iloperidone, 7.6% for 
      haloperidol, 6.2% for risperidone, and 4.8% for placebo. Iloperidone groups 
      showed better overall performance on the Extrapyramidal Symptom Rating Scale and 
      Barnes Akathisia Scale than risperidone or haloperidol groups. Patients taking 
      iloperidone experienced a mild weight increase (range, 1.5-2.1 kg) similar to 
      that of risperidone (1.5 kg), whereas those on haloperidol and placebo showed 
      mean weight loss (-0.1 kg and -0.3 kg, respectively). QTc interval significantly 
      increased across all iloperidone groups (least squares mean change from baseline 
      to end point, 2.9-9.1 msec) and for haloperidol (5.0 msec). No significant QTc 
      changes occurred in the risperidone or placebo groups. Iloperidone was associated 
      with no change from baseline in total cholesterol, mild elevation in serum 
      glucose, and slight decrease in triglycerides. Prolactin levels decreased with 
      iloperidone and increased significantly with risperidone and haloperidol. These 
      short-term trials suggest that iloperidone has a reassuring safety profile in 
      many of the areas that are of potential concern, including relatively low dropout 
      rates because of AEs, low extrapyramidal symptoms, akathisia, and prolactin 
      elevation, and a modest short-term effect on weight gain.
FAU - Weiden, Peter J
AU  - Weiden PJ
AD  - Center for Cognitive Medicine, Chicago, IL 60612, USA. pweiden@psych.uic.edu
FAU - Cutler, Andrew J
AU  - Cutler AJ
FAU - Polymeropoulos, Mihael H
AU  - Polymeropoulos MH
FAU - Wolfgang, Curt D
AU  - Wolfgang CD
LA  - eng
PT  - Journal Article
PT  - Meta-Analysis
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - J Clin Psychopharmacol
JT  - Journal of clinical psychopharmacology
JID - 8109496
RN  - 0 (Antipsychotic Agents)
RN  - 0 (Isoxazoles)
RN  - 0 (Piperidines)
RN  - VPO7KJ050N (iloperidone)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Akathisia, Drug-Induced/etiology
MH  - Antipsychotic Agents/administration & dosage/*adverse effects/therapeutic use
MH  - Basal Ganglia Diseases/*chemically induced
MH  - Double-Blind Method
MH  - Female
MH  - Humans
MH  - Isoxazoles/administration & dosage/*adverse effects/therapeutic use
MH  - Long QT Syndrome/chemically induced
MH  - Male
MH  - Middle Aged
MH  - Patient Dropouts
MH  - Piperidines/administration & dosage/*adverse effects/therapeutic use
MH  - Prospective Studies
MH  - Psychotic Disorders/drug therapy
MH  - Randomized Controlled Trials as Topic
MH  - Schizophrenia/drug therapy
MH  - Weight Gain/drug effects
EDAT- 2008/05/06 09:00
MHDA- 2008/06/27 09:00
CRDT- 2008/05/06 09:00
PHST- 2008/05/06 09:00 [pubmed]
PHST- 2008/06/27 09:00 [medline]
PHST- 2008/05/06 09:00 [entrez]
AID - 10.1097/JCP.0b013e3181694f5a [doi]
PST - ppublish
SO  - J Clin Psychopharmacol. 2008 Apr;28(2 Suppl 1):S12-9. doi: 
      10.1097/JCP.0b013e3181694f5a.