PMID- 18854723
OWN - NLM
STAT- MEDLINE
DCOM- 20090122
LR  - 20151119
IS  - 0268-1315 (Print)
IS  - 0268-1315 (Linking)
VI  - 23
IP  - 6
DP  - 2008 Nov
TI  - Efficacy and safety of oral paliperidone extended-release tablets in the 
      treatment of acute schizophrenia: pooled data from three 52-week open-label 
      studies.
PG  - 343-56
LID - 10.1097/YIC.0b013e328314e1f3 [doi]
AB  - Long-term efficacy and safety of paliperidone extended-release tablets (3-12 
      mg/day) were evaluated in pooled data from 52-week open-label extension (OLE) 
      phases of three 6-week, placebo-controlled, double-blind (DB) trials involving 
      1083 schizophrenia patients. Forty-seven percent of patients completed the OLE 
      phase. Outcome measures included Positive and Negative Syndrome Scale and 
      Personal and Social Performance scale scores. Improvements observed on both 
      scales in active treatment groups during the DB phases were maintained during the 
      OLE phase. Most commonly (> or =10% patients) reported adverse events (AEs) were 
      insomnia, headache, and akathisia. One or more serious AEs were reported by 16% 
      of patients; two patients had a treatment-emergent AE that resulted in death 
      (suicide). Extrapyramidal symptom-related AEs were reported by 25% of patients. 
      Median maximum movement disorder rating scale scores indicated no severity change 
      during the OLE. Mean (+/-SD) increase in body weight from OLE baseline to end 
      point was 1.1+/-5.47 kg across treatment groups and there were no clinically 
      meaningful changes for plasma glucose, insulin or lipid levels. This analysis 
      shows that paliperidone extended-release can maintain improvements in symptoms 
      and functioning and is generally well tolerated for up to 52 weeks in 
      schizophrenia patients.
FAU - Emsley, Robin
AU  - Emsley R
AD  - Department of Psychiatry, University of Stellenbosch, Tygerberg, Cape Town, South 
      Africa. rae@gerga.sun.ac.za
FAU - Berwaerts, Joris
AU  - Berwaerts J
FAU - Eerdekens, Marielle
AU  - Eerdekens M
FAU - Kramer, Michelle
AU  - Kramer M
FAU - Lane, Rosanne
AU  - Lane R
FAU - Lim, Pilar
AU  - Lim P
FAU - Hough, David
AU  - Hough D
FAU - Palumbo, Joseph
AU  - Palumbo J
LA  - eng
PT  - Journal Article
PT  - Meta-Analysis
PT  - Research Support, Non-U.S. Gov't
PL  - England
TA  - Int Clin Psychopharmacol
JT  - International clinical psychopharmacology
JID - 8609061
RN  - 0 (Antipsychotic Agents)
RN  - 0 (Delayed-Action Preparations)
RN  - 0 (Isoxazoles)
RN  - 0 (Pyrimidines)
RN  - 0 (Tablets)
RN  - R8P8USM8FR (Paliperidone Palmitate)
SB  - IM
MH  - Acute Disease
MH  - Administration, Oral
MH  - Adult
MH  - Antipsychotic Agents/*administration & dosage/adverse effects
MH  - Clinical Trials as Topic
MH  - Delayed-Action Preparations
MH  - Female
MH  - Humans
MH  - Isoxazoles/*administration & dosage/adverse effects
MH  - Male
MH  - Middle Aged
MH  - Multicenter Studies as Topic
MH  - Paliperidone Palmitate
MH  - Psychiatric Status Rating Scales
MH  - Pyrimidines/*administration & dosage/adverse effects
MH  - Schizophrenia/*drug therapy
MH  - Schizophrenic Psychology
MH  - Severity of Illness Index
MH  - Tablets
MH  - Time Factors
MH  - Treatment Outcome
EDAT- 2008/10/16 09:00
MHDA- 2009/01/23 09:00
CRDT- 2008/10/16 09:00
PHST- 2008/10/16 09:00 [pubmed]
PHST- 2009/01/23 09:00 [medline]
PHST- 2008/10/16 09:00 [entrez]
AID - 00004850-200811000-00006 [pii]
AID - 10.1097/YIC.0b013e328314e1f3 [doi]
PST - ppublish
SO  - Int Clin Psychopharmacol. 2008 Nov;23(6):343-56. doi: 
      10.1097/YIC.0b013e328314e1f3.