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
Journal of the Korean Society of Biological Psychiatry
;
: 12-20, 2013.
Article
in Korean
| WPRIM
| ID: wpr-725244
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.
Full text:
Available
Index:
WPRIM (Western Pacific)
Main subject:
Pyrimidines
/
Schizophrenia
/
Antipsychotic Agents
/
Prospective Studies
/
Isoxazoles
Type of study:
Controlled clinical trial
/
Observational study
Limits:
Humans
Language:
Korean
Journal:
Journal of the Korean Society of Biological Psychiatry
Year:
2013
Type:
Article
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