PMID- 23428785
OWN - NLM
STAT- MEDLINE
DCOM- 20150124
LR  - 20151119
IS  - 1941-2010 (Electronic)
IS  - 1935-1232 (Linking)
VI  - 8
IP  - 1
DP  - 2014 Apr
TI  - Safety of paliperidone extended-release in patients with schizophrenia or 
      schizoaffective disorder and hepatic disease.
PG  - 8-20
LID - 10.3371/CSRP.AMCA.021513 [doi]
AB  - BACKGROUND/PURPOSE: Patients with schizophrenia often suffer from comorbid 
      hepatic disease. This multicenter, open-label, single-arm, crossover study 
      evaluated the safety and efficacy of paliperidone extended-release (ER) in 
      patients with schizophrenia or schizoaffective disorder and hepatic disease. 
      METHODS: The study comprised a screening period, followed by 9 weeks' open-label 
      treatment, divided into 2 phases. Phase 1 (4 weeks) was a continuation of usual 
      antipsychotic treatment (UAT); phase 2 (5 weeks) consisted of a 1-week 
      cross-titration from UAT to flexibly dosed paliperidone ER (3-12 mg/d), followed 
      by 4 weeks of paliperidone ER alone. Treatment-emergent adverse events (TEAEs), 
      including those considered more relevant to antipsychotic treatment (prespecified 
      adverse events [AEs]), were analyzed. RESULTS: Although more subjects reported 
      TEAEs during the paliperidone ER alone period than during the UAT period, no 
      significant differences occurred in prespecified AE rates. No new safety signals 
      were detected, and minimal shifts in liver function test values were observed. 
      Improvements in psychiatric symptoms and functioning were observed after 4 weeks' 
      paliperidone ER treatment. CONCLUSIONS: This study suggests that paliperidone ER 
      is well tolerated in patients with schizophrenia or schizoaffective disorder and 
      hepatic disease. To the best of our knowledge, this is the largest prospective 
      study to date in this population.
FAU - Amatniek, Joan
AU  - Amatniek J
AD  - Janssen Scientific Affairs, Bristol-Myers Squibb, LLC, Titusville, NJ, 
      Plainsboro, NJ, USA.
FAU - Canuso, Carla M
AU  - Canuso CM
AD  - Janssen Research & Development, LLC, Titusville, NJ, USA.
FAU - Deutsch, Stephen I
AU  - Deutsch SI
AD  - Eastern Virginia Medical School, Norfolk, VA, USA.
FAU - Henderson, David C
AU  - Henderson DC
AD  - Harvard Medical School, Boston, MA, USA.
FAU - Mao, Lian
AU  - Mao L
AD  - Janssen Research & Development, LLC, Titusville, NJ, USA.
FAU - Mikesell, Chris
AU  - Mikesell C
AD  - Janssen Scientific Affairs, LLC, Titusville, NJ, USA.
FAU - Rodriguez, Stephen
AU  - Rodriguez S
AD  - Janssen Scientific Affairs, LLC, Titusville, NJ, USA.
FAU - Sheehan, John
AU  - Sheehan J
AD  - Janssen Scientific Affairs, LLC, Titusville, NJ, Fort Washington, PA, USA.
FAU - Alphs, Larry
AU  - Alphs L
AD  - Janssen Scientific Affairs, LLC, Titusville, NJ, USA.
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Clin Schizophr Relat Psychoses
JT  - Clinical schizophrenia & related psychoses
JID - 101312513
RN  - 0 (Antipsychotic Agents)
RN  - 0 (Delayed-Action Preparations)
RN  - 0 (Isoxazoles)
RN  - 0 (Pyrimidines)
RN  - R8P8USM8FR (Paliperidone Palmitate)
SB  - IM
MH  - Antipsychotic Agents/adverse effects/therapeutic use
MH  - Cross-Over Studies
MH  - Delayed-Action Preparations/adverse effects/therapeutic use
MH  - Female
MH  - Humans
MH  - Isoxazoles/adverse effects/*therapeutic use
MH  - Liver Diseases/*complications
MH  - Liver Function Tests/methods/statistics & numerical data
MH  - Male
MH  - Middle Aged
MH  - Paliperidone Palmitate
MH  - Psychiatric Status Rating Scales/statistics & numerical data
MH  - Psychotic Disorders/*complications/diagnosis/*drug therapy
MH  - Pyrimidines/adverse effects/*therapeutic use
MH  - Schizophrenia/*complications/diagnosis/*drug therapy
MH  - Treatment Outcome
OTO - NOTNLM
OT  - Atypical Antipsychotic
OT  - Hepatic Disease
OT  - Paliperidone ER
OT  - Schizophrenia
EDAT- 2013/02/23 06:00
MHDA- 2015/01/27 06:00
CRDT- 2013/02/23 06:00
PHST- 2013/02/23 06:00 [entrez]
PHST- 2013/02/23 06:00 [pubmed]
PHST- 2015/01/27 06:00 [medline]
AID - F24612719RK22422 [pii]
AID - 10.3371/CSRP.AMCA.021513 [doi]
PST - ppublish
SO  - Clin Schizophr Relat Psychoses. 2014 Apr;8(1):8-20. doi: 
      10.3371/CSRP.AMCA.021513.