title: Safety of paliperidone extended-release in patients with schizophrenia or schizoaffective disorder and hepatic disease.
abstract: OBJECTIVE
  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.
authors: Janssen Scientific Affairs, Bristol-Myers Squibb, LLC, Titusville, NJ, Plainsboro, NJ, USA.
authors: Joan
authors: J
authors: Amatniek
authors: Janssen Research & Development, LLC, Titusville, NJ, USA.
authors: Carla M
authors: CM
authors: Canuso
authors: Eastern Virginia Medical School, Norfolk, VA, USA.
authors: Stephen I
authors: SI
authors: Deutsch
authors: Harvard Medical School, Boston, MA, USA.
authors: David C
authors: DC
authors: Henderson
authors: Janssen Research & Development, LLC, Titusville, NJ, USA.
authors: Lian
authors: L
authors: Mao
authors: Janssen Scientific Affairs, LLC, Titusville, NJ, USA.
authors: Chris
authors: C
authors: Mikesell
authors: Janssen Scientific Affairs, LLC, Titusville, NJ, USA.
authors: Stephen
authors: S
authors: Rodriguez
authors: Janssen Scientific Affairs, LLC, Titusville, NJ, Fort Washington, PA, USA.
authors: John
authors: J
authors: Sheehan
authors: Janssen Scientific Affairs, LLC, Titusville, NJ, USA.
authors: Larry
authors: L
authors: Alphs
mesh_terms: D014150:Antipsychotic Agents / Q000009:adverse effects / Q000627:therapeutic use; D018592:Cross-Over Studies; D003692:Delayed-Action Preparations / Q000009:adverse effects / Q000627:therapeutic use; D005260:Female; D006801:Humans; D007555:Isoxazoles / Q000009:adverse effects / Q000627:therapeutic use*; D008107:Liver Diseases / Q000150:complications*; D008111:Liver Function Tests / Q000379:methods / Q000706:statistics & numerical data; D008297:Male; D008875:Middle Aged; D000068882:Paliperidone Palmitate; D011569:Psychiatric Status Rating Scales / Q000706:statistics & numerical data; D011618:Psychotic Disorders / Q000150:complications* / Q000175:diagnosis / Q000188:drug therapy*; D011743:Pyrimidines / Q000009:adverse effects / Q000627:therapeutic use*; D012559:Schizophrenia / Q000150:complications* / Q000175:diagnosis / Q000188:drug therapy*; D016896:Treatment Outcome
chemical_list: D014150:Antipsychotic Agents; D003692:Delayed-Action Preparations; D007555:Isoxazoles; D011743:Pyrimidines; D000068882:Paliperidone Palmitate
keywords: Atypical Antipsychotic; Hepatic Disease; Paliperidone ER; Schizophrenia