Korean J Biol Psychiatry.
2013 Feb;20(1):12-20.
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
- Affiliations
-
- 1Department of Neuropsychiatry, Seoul National University College of Medicine, Seoul National University Hospital, Seoul, Korea. aym@snu.ac.kr, kys@snu.ac.kr
- 2Institute of Human Behavioral Medicine, Medical Research Institute, Seoul National University, Seoul, Korea.
- 3Department of Neuropsychiatry, Dongguk University International Hospital, Goyang, Korea.
- 4Department of Psychiatry, Kyungpook National University Hospital, Daegu, Korea.
- 5Department of Psychiatry, Inje University, Busan Paik Hospital, Busan, Korea.
- 6Department of Neuropsychiatry, Eulji University School of Medicine, Eulji General Hospital, Seoul, Korea.
- 7Department of Psychiatry, Yonsei University Gangnam Severance Hospital, Seoul, Korea.
- 8Department of Psychiatry, CHA Bundang Medical Center, Seongnam, Korea.
- 9Department of Psychiatry, Chonbuk National University Medical School, Chonbuk National University Hospital, Jeonju, Korea.
- 10Department 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.
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