title: Long-term effectiveness of flexibly dosed paliperidone extended-release: comparison among patients with schizophrenia switching from risperidone and other antipsychotic agents.
abstract: OBJECTIVE
  The current study compared the long-term effectiveness, safety, and tolerability of paliperidone extended-release (ER) among patients with schizophrenia who had switched from risperidone (risperidone group) or other antipsychotic medications (non-risperidone group) due to lack of efficacy, intolerability, or non-adherence.
  
  
  METHODS
  This open-label, prospective, multicenter, 48 week study utilized the Positive and Negative Syndrome Scale (PANSS), the Clinical Global Impression-Severity scale (CGI-S), the Personal and Social Performance scale (PSP), and the Subjective Well-being under Neuroleptics scale (SWN) to assess patients with schizophrenia. Additionally, extrapyramidal symptoms (EPS) and subjective side effects were evaluated with validated scales.
  
  
  BACKGROUND
  Clinicaltrials.gov identifier: NCT00864045.
  
  
  RESULTS
  The completion rate for this study was 51.6% (95/184), and 169 patients finished with ≥1 post-baseline assessment (81 patients in the risperidone group, 88 in the non-risperidone group). The mean (SD) PANSS total score decreased significantly from 78.3 (18.8) to 65.5 (19.7) in the risperidone group and from 79.1 (19.8) to 65.4 (20.8) in the other group (all p < 0.001). Similar to PANSS, the severity rating for overall scores of the CGI-S and the PSP scores improved significantly from baseline (all p < 0.001). The magnitude of improvement in all effectiveness measures at 48 weeks did not differ between the two groups. EPS and subjective side effects improved significantly for all patients. Akathisia (18.5%) and increased weight (14.1%) were the main adverse events. Elevated prolactin levels were identified in female subjects in the non-risperidone group.
  
  
  CONCLUSIONS
  Switching from previously unsuccessful antipsychotic treatments to paliperidone ER can be a useful option to achieve long-term improvement in symptoms and functioning for patients with schizophrenia. The clinical effectiveness appeared to be similar in patients who previously received risperidone and those treated with other antipsychotic medications. The open-label design and lack of a placebo group were limitations.
authors.affiliation: Seoul National University Hospital , Seoul , Republic of Korea.
authors.forename: Eun Young
authors.initials: EY
authors.lastname: Kim
authors.forename: Sung Man
authors.initials: SM
authors.lastname: Chang
authors.forename: Joo Cheol
authors.initials: JC
authors.lastname: Shim
authors.forename: Eun Jeong
authors.initials: EJ
authors.lastname: Joo
authors.forename: Jae Jin
authors.initials: JJ
authors.lastname: Kim
authors.forename: Yong Sik
authors.initials: YS
authors.lastname: Kim
authors.forename: Yong Min
authors.initials: YM
authors.lastname: Ahn
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D014150:Antipsychotic Agents / Q000008:administration & dosage*; D005260:Female; D006801:Humans; D007555:Isoxazoles / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D000068882:Paliperidone Palmitate; D011446:Prospective Studies; D011743:Pyrimidines / Q000008:administration & dosage*; D018967:Risperidone / Q000008:administration & dosage; D012559:Schizophrenia / Q000188:drug therapy* / Q000473:pathology / Q000503:physiopathology; D012720:Severity of Illness Index
chemical_list: D014150:Antipsychotic Agents; D007555:Isoxazoles; D011743:Pyrimidines; D018967:Risperidone; D000068882:Paliperidone Palmitate