TY - JOUR
T1 - A 64-week, multicenter, open-label study of aripiprazole effectiveness in the management of patients with schizophrenia or schizoaffective disorder in a general psychiatric outpatient setting
AU - Hsieh, Ming Hong
AU - Lin, Wei Wen
AU - Chen, Shao Tsu
AU - Chen, Kao Ching
AU - Chen, Kuang Peng
AU - Chiu, Nan Ying
AU - Huang, Chao
AU - Chang, Ching Jui
AU - Lin, Cheng Hsiu
AU - Lai, Te Jen
N1 - Funding Information:
This study was supported by Otsuka Pharmaceutical. Editorial support for the preparation of this manuscript was provided by Ogilvy Healthworld Medical Education; funding was provided by Otsuka Pharmaceutical. The authors would like to thank the following co-investigators: Nian-Sheng Tzeng, San-Yuan Huang and Yi-Chyan Chen (Tri-Service General Hospital); Chun-Te Lee (Chung Shan Medical University Hospital); Chaucer CH Lin, Hsiang-Chang Wang, Hsin-Chi Tsai, Yu-Chih Shen and Jui-Feng Tsai (Tzu Chi General Hospital); Cheng-Chiang Wu, Ming Lun Liu, Chung-Hua Mao, Szu Wei Wu, Fang-Yi Teng, Chin-Chien Shen and Chien Liang Chen (Wei Gong Memorial Hospital); I-Hui Lee, Tzung-Lieh Yeh, Yu-Ting Wang and Po-See Chen (National Cheng Kung University Hospital); Wei-Che Chiu (Cathay General Hospital); Chien-Yi Lee, Jui-Feng Chiang, Shaw-Hwa Jou, Jui-Ting Liu, Cheng-Chen Chang, Ching-Cheng Wang, Chun-Chih Chen and Helen Cheng (Changhua Christian Hospital).
PY - 2010/9/17
Y1 - 2010/9/17
N2 - Objective: To evaluate the overall long-term effectiveness of aripiprazole in patients with schizophrenia in a general psychiatric practice setting in Taiwan.Methods: This was a prospective, open-label, multicenter, post-market surveillance study in Taiwanese patients with a Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) diagnosis of schizophrenia or schizoaffective disorder requiring a switch in antipsychotic medication because current medication was not well tolerated and/or clinical symptoms were not well controlled. Eligible patients were titrated to aripiprazole (5-30 mg/day) over a 12-week switching phase, during which their previous medication was discontinued. Patients could then enter a 52-week, long-term treatment phase. Aripiprazole was flexibly dosed (5-30 mg/day) at the discretion of the treating physicians. Efficacy was assessed using the Clinical Global Impression scale Improvement (CGI-I) score, the Clinical Global Impression scale Severity (CGI-S) score, The Brief Psychiatry Rating Scale (BPRS), and the Quality of Life (QOL) scale, as well as Preference of Medicine (POM) ratings by patients and caregivers. Safety and tolerability were also assessed.Results: A total of 245 patients were enrolled and switched from their prior antipsychotic medications, and 153 patients entered the 52-week extension phase. In all, 79 patients (32.2%) completed the study. At week 64, the mean CGI-I score was 3.10 and 64.6% of patients who showed response. Compared to baseline, scores of CGI-S, QOL, and BPRS after 64 weeks of treatment also showed significant improvements. At week 12, 65.4% of subjects and 58.9% of caregivers rated aripiprazole as better than the prestudy medication on the POM. The most frequently reported adverse events (AEs) were headache, auditory hallucinations and insomnia. A total of 13 patients (5.3%) discontinued treatment due to AEs. No statistically significant changes were noted with respect to fasting plasma glucose, lipid profile, body weight, and body mass index after long-term treatment with aripiprazole.Conclusions: Although the discontinuation rate was high, aripiprazole was found to be effective, safe and well tolerated in the long-term treatment of Taiwanese patients with schizophrenia who continued to receive treatment for 64 weeks.
AB - Objective: To evaluate the overall long-term effectiveness of aripiprazole in patients with schizophrenia in a general psychiatric practice setting in Taiwan.Methods: This was a prospective, open-label, multicenter, post-market surveillance study in Taiwanese patients with a Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) diagnosis of schizophrenia or schizoaffective disorder requiring a switch in antipsychotic medication because current medication was not well tolerated and/or clinical symptoms were not well controlled. Eligible patients were titrated to aripiprazole (5-30 mg/day) over a 12-week switching phase, during which their previous medication was discontinued. Patients could then enter a 52-week, long-term treatment phase. Aripiprazole was flexibly dosed (5-30 mg/day) at the discretion of the treating physicians. Efficacy was assessed using the Clinical Global Impression scale Improvement (CGI-I) score, the Clinical Global Impression scale Severity (CGI-S) score, The Brief Psychiatry Rating Scale (BPRS), and the Quality of Life (QOL) scale, as well as Preference of Medicine (POM) ratings by patients and caregivers. Safety and tolerability were also assessed.Results: A total of 245 patients were enrolled and switched from their prior antipsychotic medications, and 153 patients entered the 52-week extension phase. In all, 79 patients (32.2%) completed the study. At week 64, the mean CGI-I score was 3.10 and 64.6% of patients who showed response. Compared to baseline, scores of CGI-S, QOL, and BPRS after 64 weeks of treatment also showed significant improvements. At week 12, 65.4% of subjects and 58.9% of caregivers rated aripiprazole as better than the prestudy medication on the POM. The most frequently reported adverse events (AEs) were headache, auditory hallucinations and insomnia. A total of 13 patients (5.3%) discontinued treatment due to AEs. No statistically significant changes were noted with respect to fasting plasma glucose, lipid profile, body weight, and body mass index after long-term treatment with aripiprazole.Conclusions: Although the discontinuation rate was high, aripiprazole was found to be effective, safe and well tolerated in the long-term treatment of Taiwanese patients with schizophrenia who continued to receive treatment for 64 weeks.
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U2 - 10.1186/1744-859X-9-35
DO - 10.1186/1744-859X-9-35
M3 - Article
C2 - 20849577
AN - SCOPUS:77957338360
VL - 9
JO - Annals of General Psychiatry
JF - Annals of General Psychiatry
SN - 1744-859X
M1 - 35
ER -