Autor: |
Naber, D, Baker, RA, Eramo, A, Forray, C, Hansen, K, Sapin, C, Peters-Strickland, T, Nylander, A-G, Hertel, P, Schmidt, SN, Loze, J-Y, Potkin, SG |
Jazyk: |
angličtina |
Rok vydání: |
2018 |
Předmět: |
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Zdroj: |
Naber, D; Baker, RA; Eramo, A; Forray, C; Hansen, K; Sapin, C; et al.(2018). y Long-term effectiveness of aripiprazole once-monthly for schizophrenia is maintained in the QUALIFY extension study. SCHIZOPHRENIA RESEARCH, 192, 205-210. doi: 10.1016/j.schres.2017.04.013. UC Irvine: Retrieved from: http://www.escholarship.org/uc/item/8c13n4gn |
DOI: |
10.1016/j.schres.2017.04.013. |
Popis: |
To evaluate long-term safety and effectiveness of continued treatment with aripiprazole once-monthly 400mg (AOM 400) in patients with schizophrenia.Patients who completed the QUALIFY study (NCT01795547) in the AOM 400 arm were eligible for 6 additional once-monthly injections of AOM 400 during an open-label, 24-week extension (NCT01959035). Safety data were collected at each visit. Effectiveness measures included change from baseline in health-related qualify of life and functioning on the Heinrichs-Carpenter Quality of Life scale (QLS) and Clinical Global Impression - Severity (CGI-S) scale.Of the 88 patients enrolled, 77 (88%) completed the extension study. Most common treatment-emergent adverse events (incidence ≥2%) were weight increased (6/88, 7%), toothache (3/88, 3%) and headache (3/88, 3%). Effectiveness was maintained during the extension study, with small but continued improvements from baseline: the least squares mean (LSM) change (95% CI) from baseline to week 24 was 2.32 (-1.21 to 5.85) for the QLS total score and -0.10 (-0.26 to 0.06) for the CGI-S score. The aggregated LSM change (95% CI) from baseline of the lead-in study to week 24 of the extension study was 11.54 (7.45 to 15.64) for the QLS total score and -0.98 (-1.18 to -0.79) for the CGI-S score.AOM 400 was well tolerated in patients continuing AOM treatment during the extension phase of the QUALIFY study. Robust and clinically meaningful improvements in health-related quality of life and functioning were maintained, further supporting the long-term clinical benefits of AOM 400 for the treatment of patients with schizophrenia. |
Databáze: |
OpenAIRE |
Externí odkaz: |
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