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

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., Princ...

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Autores principales:	De Hert M, Eramo A, Landsberg W, Kostic D, Tsai LF, Baker RA
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2015
Materias:	Neurosciences. Biological psychiatry. Neuropsychiatry RC321-571 Neurology. Diseases of the nervous system RC346-429
Acceso en línea:	https://doaj.org/article/7df5b485319d405f9626c74dc9091453
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spelling	oai:doaj.org-article:7df5b485319d405f9626c74dc90914532021-12-02T07:30:47ZEfficacy and safety of aripiprazole once-monthly in obese and nonobese patients with schizophrenia: a post hoc analysis1178-2021https://doaj.org/article/7df5b485319d405f9626c74dc90914532015-05-01T00:00:00Zhttp://www.dovepress.com/efficacy-and-safety-of-aripiprazole-once-monthly-in-obese-and-nonobese-peer-reviewed-article-NDThttps://doaj.org/toc/1178-2021Marc 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-monthlyDe Hert MEramo ALandsberg WKostic DTsai LFBaker RADove Medical PressarticleNeurosciences. Biological psychiatry. NeuropsychiatryRC321-571Neurology. Diseases of the nervous systemRC346-429ENNeuropsychiatric Disease and Treatment, Vol 2015, Iss default, Pp 1299-1306 (2015)
institution	DOAJ
collection	DOAJ
language	EN
topic	Neurosciences. Biological psychiatry. Neuropsychiatry RC321-571 Neurology. Diseases of the nervous system RC346-429
spellingShingle	Neurosciences. Biological psychiatry. Neuropsychiatry RC321-571 Neurology. Diseases of the nervous system RC346-429 De Hert M Eramo A Landsberg W Kostic D Tsai LF Baker RA Efficacy and safety of aripiprazole once-monthly in obese and nonobese patients with schizophrenia: a post hoc analysis
description	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
format	article
author	De Hert M Eramo A Landsberg W Kostic D Tsai LF Baker RA
author_facet	De Hert M Eramo A Landsberg W Kostic D Tsai LF Baker RA
author_sort	De Hert M
title	Efficacy and safety of aripiprazole once-monthly in obese and nonobese patients with schizophrenia: a post hoc analysis
title_short	Efficacy and safety of aripiprazole once-monthly in obese and nonobese patients with schizophrenia: a post hoc analysis
title_full	Efficacy and safety of aripiprazole once-monthly in obese and nonobese patients with schizophrenia: a post hoc analysis
title_fullStr	Efficacy and safety of aripiprazole once-monthly in obese and nonobese patients with schizophrenia: a post hoc analysis
title_full_unstemmed	Efficacy and safety of aripiprazole once-monthly in obese and nonobese patients with schizophrenia: a post hoc analysis
title_sort	efficacy and safety of aripiprazole once-monthly in obese and nonobese patients with schizophrenia: a post hoc analysis
publisher	Dove Medical Press
publishDate	2015
url	https://doaj.org/article/7df5b485319d405f9626c74dc9091453
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Efficacy and safety of aripiprazole once-monthly in obese and nonobese patients with schizophrenia: a post hoc analysis

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