TY - JOUR
T1 - A prospective, multicentre, open-label study of aripiprazole in the management of patients with schizophrenia in psychiatric practice in Europe
T2 - Broad Effectiveness Trial with Aripiprazole in Europe (EU-BETA)
AU - Wolf, Jürgen
AU - Janssen, Firmin
AU - Lublin, Henrik
AU - Salokangas, Raimo K R
AU - Allain, Hervé
AU - Smeraldi, Enrico
AU - Bernardo, Miguel
AU - Millar, Helen
AU - Pans, Miranda
AU - Adelbrecht, Christine
AU - Laughton, Jim
AU - Werner, Christian
AU - Maier, Wolfgang
PY - 2007/10
Y1 - 2007/10
N2 - 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 [SC] 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 - I) 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, [CI]: 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% CI: 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.
AB - 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 [SC] 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 - I) 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, [CI]: 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% CI: 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.
KW - Aripiprazole
KW - Atypical antipsychotics
KW - Effectiveness
KW - Naturalistic study
KW - Outpatient
KW - Schizophrenia
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U2 - 10.1185/030079907X225448
DO - 10.1185/030079907X225448
M3 - Article
C2 - 17706003
AN - SCOPUS:35648970593
VL - 23
SP - 2313
EP - 2323
JO - Current Medical Research and Opinion
JF - Current Medical Research and Opinion
SN - 0300-7995
IS - 10
ER -