Long-term effectiveness of aripiprazole once-monthly for schizophrenia is maintained in the QUALIFY extension study

SCHIZOPHRENIA RESEARCH

卷:192

Article

Naber, Dieter¹  Baker, Ross A.²  Eramo, Anna³  Forray, Carlos⁴  Hansen, Karina⁵  Sapin, Christophe⁵  Peters-Strickland, Timothy²  Nylander, Anna-Greta⁶  Hertel, Peter⁶  Schmidt, Simon Nitschky⁶  Loze, Jean-Yves⁷  Potkin, Steven G.⁸ 

[1] Univ Med Ctr Hamburg Eppendorf, Dept Psychiat & Psychotherapy, Wellingsbutteler Landstr 136, D-22337 Hamburg, Germany

[2] Otsuka Pharmaceut Dev & Commercializat Inc, 508 Carnegie Ctr, Princeton, NJ 08540 USA

[3] Lundbeck LLC, 4 Pkwy North, Deerfield, IL 60015 USA

[4] Lundbeck LLC, 215 Coll Rd, Paramus, NJ 07652 USA

[5] Lundbeck SAS, 41-43 Quai du President Roosevelt, F-92445 Issy Les Moulineaux, France

[6] H Lundbeck & Co AS, Ottiliavej 9, DK-2500 Valby, Denmark

[7] Otsuka Pharmaceut Europe Ltd, Framewood Rd, Wexham SL3 6PJ, England

[8] Univ Calif Irvine, Dept Psychiat & Human Behav, 5251 Calif Ave,Suite 240,Mail Code 1680, Irvine, CA 92617 USA

关键词: Aripiprazole once-monthly;    Schizophrenia;    Maintenance treatment;    Quality of life;   

DOI  :  10.1016/j.schres.2017.04.013

来源: Elsevier

【 摘 要 】

Objective: To evaluate long-term safety and effectiveness of continued treatment with aripiprazole once-monthly 400 mg (AOM 400) in patients with schizophrenia. Methods: 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. Results: 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 (-121 to 5.85) for the QLS total score and -0.10 (-026 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. Conclusions: 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. (C) 2017 The Authors. Published by Elsevier B.V.

【 授权许可】

Free