Back to Journals » Neuropsychiatric Disease and Treatment » Volume 11

Efficacy and safety of aripiprazole once-monthly in obese and nonobese patients with schizophrenia: a post hoc analysis

Authors De Hert M, Eramo A, Landsberg W, Kostic D, Tsai L, Baker RA

Received 7 January 2015

Accepted for publication 12 March 2015

Published 27 May 2015 Volume 2015:11 Pages 1299—1306

DOI https://doi.org/10.2147/NDT.S80479

Checked for plagiarism Yes

Review by Single-blind

Peer reviewer comments 3

Editor who approved publication: Dr Roger Pinder

Marc De Hert,1 Anna Eramo,2 Wally Landsberg,3 Dusan Kostic,4 Lan-Feng Tsai,5 Ross A Baker4

1Department of Neurosciences, KU Leuven, Belgium; 2Lundbeck LLC, Deerfield, IL, USA; 3Otsuka Pharmaceutical Europe Ltd., Wexham, UK; 4Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, NJ, USA; 5Otsuka Pharmaceutical Development & Commercialization, Inc., Rockville, MD, USA

Purpose: To assess the efficacy and safety of aripiprazole once-monthly 400 mg (AOM 400), an extended-release injectable suspension of aripiprazole, in obese and nonobese patients.
Patients and methods: This post hoc analysis of a 38-week randomized, double-blind, active-controlled, noninferiority study (NCT00706654) compared the clinical profile of AOM 400 in obese (body mass index [BMI] ≥30 kg/m2) and nonobese (BMI <30 kg/m2) patients with schizophrenia for ≥3 years. Patients were randomized 2:2:1 to AOM 400, oral aripiprazole 10–30 mg/d, or aripiprazole once-monthly 50 mg (AOM 50 mg) (subtherapeutic dose). Within obese and nonobese patient subgroups, treatment-group differences in Kaplan–Meier estimated relapse rates at week 26 (z-test) and in observed rates of impending relapse through week 38 (chi-square test) were analyzed. Treatment-emergent adverse events (TEAEs) (>10% in any treatment group) were summarized.
Results: At baseline of the randomized phase, obesity rates were similar among patients randomized to AOM 400 (n=95/265, 36%), oral aripiprazole (n=95/266, 36%), and AOM 50 mg (n=43/131, 33%). In both obese and nonobese patients, relapse rates through week 38 for patients randomized to AOM 400 (obese, 7.4%; nonobese, 8.8%) were similar to those in patients on oral aripiprazole (obese, 8.4%; nonobese, 7.6%), whereas relapse rates were significantly lower with AOM 400 versus AOM 50 mg (obese, 27.9% [P=0.0012]; nonobese, 19.3% [P=0.0153]). The most common TEAEs with AOM 400 in obese and nonobese patients were insomnia (12.6% and 11.2%), headache (12.6% and 8.2%), injection site pain (11.6% and 5.3%), akathisia (10.5% and 10.6%), upper respiratory tract infection (10.5% and 4.7%), weight increase (10.5% and 8.2%), and weight decrease (6.3% and 11.8%). Within the AOM 400 group, 7.6% of patients who were nonobese at baseline became obese, and 17.9% of obese patients became nonobese during randomized treatment.
Conclusion: The clinical profile of AOM 400 was similar in obese and nonobese patients.

Keywords: antipsychotic, long-acting injectable, schizophrenia, obesity, aripiprazole once-monthly

Creative Commons License This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution - Non Commercial (unported, v3.0) License. By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms.

Download Article [PDF]  View Full Text [HTML][Machine readable]