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).
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.


CONCLUSIONS
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.
Wolf
Jürgen
J
Department of Psychiatry, Charité - University Medicine Berlin, Campus Benjamin Franklin, Berlin, Germany. Juergen.wolf@abw-zh.ch
Janssen
Firmin
F
Lublin
Henrik
H
Salokangas
Raimo K R
RK
Allain
Hervé
H
Smeraldi
Enrico
E
Bernardo
Miguel
M
Millar
Helen
H
Pans
Miranda
M
Adelbrecht
Christine
C
Laughton
Jim
J
Werner
Christian
C
Maier
Wolfgang
W
D014150:Antipsychotic Agents / Q000627:therapeutic use*; D000068180:Aripiprazole; D005060:Europe; D006801:Humans; D010879:Piperazines / Q000627:therapeutic use*; D011446:Prospective Studies; D015363:Quinolones / Q000627:therapeutic use*; D012559:Schizophrenia / Q000188:drug therapy*; D011795:Surveys and Questionnaires; D016896:Treatment Outcome
D014150:Antipsychotic Agents; D010879:Piperazines; D015363:Quinolones; D000068180:Aripiprazole