Korean J Psychopharmacol.  2012 Jul;23(3):97-106.

Efficacy and Safety of Paliperidone Extended Release in Schizophrenia Patients Requiring a Switch in Antipsychotic Medication by Switching Previous Antipsychotics to Paliperidone Extended Release

Affiliations
  • 1Department of Psychiatry, Inha University College of Medicine, Inha University Hospital, Incheon, Korea. kce320@inha.ac.kr
  • 2Department of Psychiatry, Soonchunhyang University College of Medicine, Bucheon Hospital, Bucheon, Korea.
  • 3Department of Psychiatry, Dongguk University College of Medicine, Ilsan Hospital, Goyang, Korea. kys@snu.ac.kr
  • 4Department of Psychiatry, Chonnam National University College of Medicine, Chonnam National University Hospital, Gwangju, Korea.
  • 5Department of Psychiatry, Seoul National University College of Medicine, Seoul National University Hospital, Seoul, Korea.
  • 6Department of Psychiatry, Seoul National University College of Medicine, Boramae Medical Center, Seoul, Korea.
  • 7Department of Psychiatry, Sungkyunkwan University School of Medicine, Samsung Medical Center, Seoul, Korea.
  • 8Department of Psychiatry, The Catholic University of Korea College of Medicine, Incheon St. Mary's Hospital, Incheon, Korea.
  • 9Department of Psychiatry, Hallym University College of Medicine, Chuncheon Sacred Heart Hospital, Chuncheon, Korea.
  • 10Department of Psychiatry, Yonsei University College of Medicine, Gangnam Severance Hospital, Seoul, Korea.
  • 11Department of Psychiatry, Korea University College of Medicine, Anam Hospital, Seoul, Korea.
  • 12Department of Psychiatry, Chung-Ang University College of Medicine, Chung-Ang University Hospital, Seoul, Korea.
  • 13Department of Psychiatry, Inje University College of Medicine, Ilsan Paik Hospital, Goyang, Korea.
  • 14Department of Psychiatry, National Health Insurance Corporation Ilsan Hospital, Goyang, Korea.
  • 15Department of Psychiatry, Ajou University College of Medicine, Ajou University Hospital, Suwon, Korea.
  • 16Department of Psychiatry, Kyung Hee University College of Medicine, Kyung Hee University Hospital, Seoul, Korea.
  • 17Department of Psychiatry, The Catholic University of Korea College of Medicine, St. Vincent's Hospital, Suwon, Korea.

Abstract


OBJECTIVE
This study aimed to evaluate the clinical efficacy, safety, and tolerability of paliperidone extended release (ER) in patients with schizophrenia by switching previous antipsychotics to paliperidone ER.
METHODS
An open-label, 24 weeks, prospective, non-comparative, multi-center study evaluated total 387 patients with schizophrenia requiring a switch in antipsychotic medication due to suboptimal efficacy, intolerability, and non-compliance. Patients were switched to flexible-dose trial of paliperidone ER (3-12 mg/day). Efficacy was measured by Krawiecka Scale, Clinical Global Impression-Schizophrenia-Severity (CGI-SCH-S), Clinical Global Impression-Schizophrenia-Improvement (CGI-SCH-I), sleep visual analog scale (VAS), and Personal and Social Performance Scale (PSP). Safety assessments included adverse events (AEs), evaluation of extrapyramidal symptoms (EPS) using the Drug Induced Extrapyramidal Symptoms Scale (DIEPSS), and laboratory tests.
RESULTS
Data from a total of 321 subjects who took the paliperidone ER and had at least one follow-up assessment without a major protocol violation were analyzed. Switching to paliperidone ER led to a significant improvement in the Krawiecka, CGI-SCH-S, CGI-SCH-I, PSP, and DIEPSS scales. However, serum prolactin levels and metabolic parameters including body weight and waist circumference were significantly increased. Insomnia was the most common adverse event.
CONCLUSION
This study suggested that patients with schizophrenia who showed insufficient response or intolerance to other previous antipsychotics can be switched to paliperidone ER, with efficacy, safety, and tolerability.

Keyword

Schizophrenia; Atypical antipsychotic; Paliperidone ER; Efficacy; Tolerability

MeSH Terms

Antipsychotic Agents
Body Weight
Follow-Up Studies
Humans
Isoxazoles
Prolactin
Prospective Studies
Pyrimidines
Schizophrenia
Sleep Initiation and Maintenance Disorders
Waist Circumference
Weights and Measures
Antipsychotic Agents
Isoxazoles
Prolactin
Pyrimidines
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