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.
- Author:
You Ra CHOI
1
;
Dong Chung JUNG
;
Eun Young KIM
;
Se Hyun KIM
;
Hyun Jeong LEE
;
Nam Young LEE
;
Sung Man CHANG
;
Joo Cheol SHIM
;
Eun Jeong JOO
;
Jae Jin KIM
;
Sang Hyuk LEE
;
Young Chul CHUNG
;
Yong Sik KIM
;
Yong Min AHN
Author Information
1. Department of Neuropsychiatry, Seoul National University College of Medicine, Seoul National University Hospital, Seoul, Korea. aym@snu.ac.kr, kys@snu.ac.kr
- Publication Type:Multicenter Study ; Original Article
- Keywords:
Paliperidone ER;
Tolerability;
Safety;
Effectiveness;
Schizophrenia
- MeSH:
Antipsychotic Agents;
Humans;
Isoxazoles;
Prospective Studies;
Pyrimidines;
Schizophrenia
- From:Journal of the Korean Society of Biological Psychiatry
2013;20(1):12-20
- CountryRepublic of Korea
- Language:Korean
-
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.
