Effectiveness of aripiprazole once-monthly in schizophrenia patients pretreated with oral aripiprazole: a 6-month, real-life non-interventional study
Abstract Background In this study, the treatment of schizophrenia patients with aripiprazole once-monthly (AOM) was evaluated under real-life conditions in a naturalistic setting. Methods This multicenter, prospective, non-interventional study included 242 patients (age = 43.1 ± 15.1 years, 55.0% ma...
| Main Authors: | , , , , , |
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| Format: | Article |
| Language: | English |
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BMC
2018-11-01
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| Series: | BMC Psychiatry |
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| Online Access: | http://link.springer.com/article/10.1186/s12888-018-1946-x |
| _version_ | 1828848455450099712 |
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| author | Daniel Schöttle Wolfgang Janetzky Daniel Luedecke Elmar Beck Christoph U. Correll Klaus Wiedemann |
| author_facet | Daniel Schöttle Wolfgang Janetzky Daniel Luedecke Elmar Beck Christoph U. Correll Klaus Wiedemann |
| author_sort | Daniel Schöttle |
| collection | DOAJ |
| description | Abstract Background In this study, the treatment of schizophrenia patients with aripiprazole once-monthly (AOM) was evaluated under real-life conditions in a naturalistic setting. Methods This multicenter, prospective, non-interventional study included 242 patients (age = 43.1 ± 15.1 years, 55.0% male) who were monitored during 6 months of AOM treatment. Endpoints included measurements of psychopathology (Brief Psychiatric Rating Scale, BPRS) and severity of illness scales (Clinical Global Impressions-Severity, CGI-S, and -Improvement, CGI-I). Furthermore, treatment-related adverse events (TRAEs) were recorded. Results At baseline, the mean BPRS total score was 54.1 ± 15.6, the mean CGI-S was 4.8 ± 0.8 and the most frequent illness category was ‘markedly ill’ (41.7%). Patients had been pretreated with oral aripiprazole for a mean duration of 9.7 months (SD: 22.3) and 87.9% were deemed by their clinician as “clinically stable” and for a mean of 5.9 months. The difference in global BPRS after 6 months was − 13.8 (SD: 16.0; 95% CI: [− 15.9; − 11.7]; p < 0.001). The proportion of patients with high CGI-S scores decreased and the proportion of patients with low scores increased significantly (p < 0.001, respectively). BPRS scores improved numerically especially well in younger patients ≤35 years, CGI-S scores decreased significantly more in this population. TRAEs were rare, with low incidences of extrapyramidal symptoms (2.9%) or weight increase (0.4%). Conclusions Treatment with AOM showed satisfying effectiveness in outpatients with further improvement of psychopathology after oral aripiprazole treatment for a considerable duration and even after having achieved clinically judged “stability”. Our findings indicate a robust therapeutic effect of AOM and substantiate previous results from randomized controlled trials under real-world routine conditions. |
| first_indexed | 2024-12-12T22:30:28Z |
| format | Article |
| id | doaj.art-41c3909ba52e44cd8a6c69762115fa48 |
| institution | Directory Open Access Journal |
| issn | 1471-244X |
| language | English |
| last_indexed | 2024-12-12T22:30:28Z |
| publishDate | 2018-11-01 |
| publisher | BMC |
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| series | BMC Psychiatry |
| spelling | doaj.art-41c3909ba52e44cd8a6c69762115fa482022-12-22T00:09:37ZengBMCBMC Psychiatry1471-244X2018-11-0118111110.1186/s12888-018-1946-xEffectiveness of aripiprazole once-monthly in schizophrenia patients pretreated with oral aripiprazole: a 6-month, real-life non-interventional studyDaniel Schöttle0Wolfgang Janetzky1Daniel Luedecke2Elmar Beck3Christoph U. Correll4Klaus Wiedemann5Klinik für Psychiatrie und Psychotherapie, Zentrum für Psychosoziale Medizin, Universitätsklinikum Hamburg-EppendorfLundbeck GmbHKlinik für Psychiatrie und Psychotherapie, Zentrum für Psychosoziale Medizin, Universitätsklinikum Hamburg-EppendorfANFOMED GmbHThe Zucker Hillside Hospital, Department of Psychiatry, Northwell HealthKlinik für Psychiatrie und Psychotherapie, Zentrum für Psychosoziale Medizin, Universitätsklinikum Hamburg-EppendorfAbstract Background In this study, the treatment of schizophrenia patients with aripiprazole once-monthly (AOM) was evaluated under real-life conditions in a naturalistic setting. Methods This multicenter, prospective, non-interventional study included 242 patients (age = 43.1 ± 15.1 years, 55.0% male) who were monitored during 6 months of AOM treatment. Endpoints included measurements of psychopathology (Brief Psychiatric Rating Scale, BPRS) and severity of illness scales (Clinical Global Impressions-Severity, CGI-S, and -Improvement, CGI-I). Furthermore, treatment-related adverse events (TRAEs) were recorded. Results At baseline, the mean BPRS total score was 54.1 ± 15.6, the mean CGI-S was 4.8 ± 0.8 and the most frequent illness category was ‘markedly ill’ (41.7%). Patients had been pretreated with oral aripiprazole for a mean duration of 9.7 months (SD: 22.3) and 87.9% were deemed by their clinician as “clinically stable” and for a mean of 5.9 months. The difference in global BPRS after 6 months was − 13.8 (SD: 16.0; 95% CI: [− 15.9; − 11.7]; p < 0.001). The proportion of patients with high CGI-S scores decreased and the proportion of patients with low scores increased significantly (p < 0.001, respectively). BPRS scores improved numerically especially well in younger patients ≤35 years, CGI-S scores decreased significantly more in this population. TRAEs were rare, with low incidences of extrapyramidal symptoms (2.9%) or weight increase (0.4%). Conclusions Treatment with AOM showed satisfying effectiveness in outpatients with further improvement of psychopathology after oral aripiprazole treatment for a considerable duration and even after having achieved clinically judged “stability”. Our findings indicate a robust therapeutic effect of AOM and substantiate previous results from randomized controlled trials under real-world routine conditions.http://link.springer.com/article/10.1186/s12888-018-1946-xLong-acting injectableLAINaturalisticSchizophreniaSchizoaffective |
| spellingShingle | Daniel Schöttle Wolfgang Janetzky Daniel Luedecke Elmar Beck Christoph U. Correll Klaus Wiedemann Effectiveness of aripiprazole once-monthly in schizophrenia patients pretreated with oral aripiprazole: a 6-month, real-life non-interventional study BMC Psychiatry Long-acting injectable LAI Naturalistic Schizophrenia Schizoaffective |
| title | Effectiveness of aripiprazole once-monthly in schizophrenia patients pretreated with oral aripiprazole: a 6-month, real-life non-interventional study |
| title_full | Effectiveness of aripiprazole once-monthly in schizophrenia patients pretreated with oral aripiprazole: a 6-month, real-life non-interventional study |
| title_fullStr | Effectiveness of aripiprazole once-monthly in schizophrenia patients pretreated with oral aripiprazole: a 6-month, real-life non-interventional study |
| title_full_unstemmed | Effectiveness of aripiprazole once-monthly in schizophrenia patients pretreated with oral aripiprazole: a 6-month, real-life non-interventional study |
| title_short | Effectiveness of aripiprazole once-monthly in schizophrenia patients pretreated with oral aripiprazole: a 6-month, real-life non-interventional study |
| title_sort | effectiveness of aripiprazole once monthly in schizophrenia patients pretreated with oral aripiprazole a 6 month real life non interventional study |
| topic | Long-acting injectable LAI Naturalistic Schizophrenia Schizoaffective |
| url | http://link.springer.com/article/10.1186/s12888-018-1946-x |
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