A prospective multicentre, open-label study of aripiprazole in the management of patients with schizophrenia in psychiatric practice in Europe: Broad Effectiveness Trial with Aripiprazole in Europe (EU-BETA)

被引:24
作者
Wolf, Juegen
Janssen, Firmin
Lublin, Henrik
Salokangas, Raimo K. R.
Allain, Herve
Smeraldi, Enrico
Adelbercht, Miguel
Laughton, Jim
Werner, Christian
Maier, Wolfgang
机构
[1] Univ Med Berlin, Dept Psychiat, Charite, D-14050 Berlin, Germany
[2] Psychiat Klin St Annendael, Diest, Belgium
[3] Ctr Psychiat, Glostrup, Denmark
[4] Turku Psychiat Clin, Turku, Finland
[5] Turku Univ Hosp, FIN-20520 Turku, Finland
[6] Univ Turku, Dept Psychiat, Turku, Finland
[7] Univ Rennes 1, Fac Med, Pharmacol Lab, Rennes, France
[8] Univ Milan, Sch Med, Inst Clin Psychiat, Milan, Italy
[9] Hosp Clin I Prov, Subdiv Psiquiatria, Barcelona, Spain
[10] Carseview Ctr, Dundee, Scotland
[11] Bristol Myers Squibb Co, Braine Lalleud, Belgium
[12] Otsuka Pharmaceut Co Ltd, London, England
[13] Otsuka Pharma GmbH, Frankfurt, Germany
[14] Univ Bonn, Dept Psychiat, D-5300 Bonn, Germany
关键词
aripiprazole; atypical antipsychotics; effectiveness; naturalistic study; outpatient; schizophrenia;
D O I
10.1185/030079907X225448
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
Objective: To examine the effectiveness of aripiprazole in schizophrenia in a naturalistic setting in 14 European countries. Methods: This multicentre, open-label study of aripiprazole evaluated outpatients with schizophrenia for whom a medication switch was clinically reasonable or antipsychotic initiation was required. Patients (n = 833) were randomized in a 4:1 ratio to aripiprazole (recommended starting dose 15 mg/day, permitted adjustment 10-30 mg/day) (n = 680) or another antipsychotic (safety control [SCI group) (n = 153) for 8 weeks. The control group received an antipsychotic different to their recent pre-study medication. The primary effectiveness measure was the Clinical Global Impression-Improvement (CGI-1) score of aripiprazole-treated patients at Week 8 (last observation carried forward [LOCF]). Patients' and caregivers' medication preference was assessed using the Preference of Medication (POM) questionnaire. The Investigator Assessment Questionnaire (IAQ) was used to record investigators' assessments of their patients' responses to the study antipsychotic. Adverse events (AEs) were recorded. Results: At endpoint (Week 8, LOCF), the mean CGI-I score of 3.16 (95% confidence interval, [Cl]: 3.04, 3.28) demonstrated the effectiveness of aripiprazole- At endpoint, 43% of aripiprazole-treated patients showed a response (CGI-I score 1/2). Aripiprazole was rated as slightly or much better than previous antipsychotic at endpoint by 68% of patients and 65% of caregivers. The mean CGI-I score (Week 8, LOCF) for the SC group was 3.37 (95% Cl: 3.14, 3.60). No major differences in the occurrence of AEs were noted between aripiprazole- and SC-treated patients. Limitations: As this is an open-label design, there may have been a bias. Secondly, the study was not powered to show differences between treatment groups and no statistical comparisons were planned. Thirdly, 8 weeks is too short to evaluate long-term effectiveness. Conclusions: Aripiprazole was effective, well tolerated and well accepted by patients and caregivers; in this naturalistic study.
引用
收藏
页码:2313 / 2323
页数:11
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