Oct, 1, 2023

Vol.30 No.2, pp. 84-88

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Review

  • Korean Journal of Biological Psychiatry
  • Volume 20(1); 2013
  • Article

Review

Korean Journal of Biological Psychiatry 2013;20(1):12-20. Published online: Jan, 1, 2013

Abstract PDF Full Text

Tolerability, Safety and Effectiveness of Paliperidone ER in Patients with Schizophrenia : A 24-Week Interim Analysis of the 48-Week Open-Label, Prospective, Switch Study

  • You Ra Choi, MD1;Dong Chung Jung, MD1;Eun Young Kim, MD1;Se Hyun Kim, MD2;Hyun Jeong Lee, MD1;Nam Young Lee, MD3;Sung Man Chang, MD4;Joo Cheol Shim, MD5;Eun Jeong Joo, MD6;Jae Jin Kim, MD7;Sang Hyuk Lee, MD8;Young Chul Chung, MD9;Yong Sik Kim, MD1,3; and Yong Min Ahn, MD1,10;
    1;Department of Neuropsychiatry, Seoul National University College of Medicine, Seoul National University Hospital, Seoul, 2;Institute of Human Behavioral Medicine, Medical Research Institute, Seoul National University, Seoul, 3;Department of Neuropsychiatry, Dongguk University International Hospital, Goyang, 4;Department of Psychiatry, Kyungpook National University Hospital, Daegu, 5;Department of Psychiatry, Inje University, Busan Paik Hospital, Busan, 6;Department of Neuropsychiatry, Eulji University School of Medicine, Eulji General Hospital, Seoul, 7;Department of Psychiatry, Yonsei University Gangnam Severance Hospital, Seoul, 8;Department of Psychiatry, CHA Bundang Medical Center, Seongnam, Seongnam, 9;Department of Psychiatry, Chonbuk National University Medical School, Chonbuk National University Hospital, Jeonju, 10;Department of Psychiatry and Behavioral Science, Institute of Human Behavioral Medicine, Seoul National University College of Medicine, Seoul, Korea
Abstract

Objectives : We investigated the tolerability, safety, and treatment response to flexible-dose paliperidone ER in patients with non-acute schizophrenia in whom previous antipsychotic drugs were ineffective.

Methods : This 24-week interim analysis of the 48-week multicenter, prospective, open-label study assessed effectiveness using the Positive and Negative Syndrome Scale (PANSS), Clinical Global Impression-Schizophrenia-Severity (CGI-SCH-S) Scale, Personal and Social Performance (PSP) and Drug Attitude Inventory (DAI). Safety and tolerability were assessed using the Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) and Liverpool University Neuroleptic Side Effect Rating Scale (LUNSERS).

Results : Effectiveness was assessed in 169 patients. Significant improvement in the PANSS total score was observed by week-1 and continued until week-24. The response rate was 33%. The CGI-SCH-S and PSP total scores significantly improved during 24 weeks ; however, no change occurred in the total DAI. Fifty-nine percent of patients reported adverse events, of which extrapyramidal symptoms were the most frequent (19.0%). The DIEPSS and LUNSERS scores were improved after 24 week.

Conclusions : Switching to the flexible-dose paliperidone ER from an ineffective antipsychotic drug was safe, tolerable, and showed a good treatment response in Korean patients with schizophrenia.

Keywords Paliperidone ER;Tolerability;Safety;Effectiveness;Schizophrenia.