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KMID : 0605620130200010012
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Journal of Korean Society of Biological Psychiatry
2013 Volume.20 No. 1 p.12 ~ p.20
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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.
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Choi You-Ra
Jung Dong-Chung
Kim Eun-Young
Lee Hyun-Jeong
Kim Yong-Sik
Ahn Yong-Min
Kim Se-Hyun
Lee Nam-Young
Chang Sung-Man
Shim Joo-Cheol
Joo Eun-Jeong
Kim Jae-Jin
Lee Sang-Hyuk
Chung Young-Chul
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Abstract
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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.
Results: 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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KEYWORD
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WordsZZPaliperidone ER, Tolerability, Safety, Effectiveness, Schizophrenia
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