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EPA-0809 - Aripiprazole Once-Monthly for the Treatment of Schizophrenia in Obese and Non-Obese Patients; a Post-Hoc Analysis

Published online by Cambridge University Press:  15 April 2020

M. De Hert ,
A. Eramo ,
W. Landsberg ,
L.F. Tsai ,
D. Kostic  and
R. Baker
M. De Hert
Affiliation:
University Psychiatric Centre, Catholic University Leuven Campus Kortenberg, Kortenberg, Belgium
A. Eramo
Affiliation:
Medical Affairs & Phase IV Clinical Affairs, H. Lundbeck A/S, Deerfield, USA
W. Landsberg
Affiliation:
Medical, Otsuka Pharmaceutical Europe, Middlesex, United Kingdom
L.F. Tsai
Affiliation:
Biostatics, Otsuka Pharmaceutical Development and Commercialization Inc., Rockville, USA
D. Kostic
Affiliation:
Global Medical Affairs, Otsuka Pharmaceutical Development and Commercialization Inc., Princeton, USA
R. Baker
Affiliation:
CNS Global Medical Affairs, Otsuka Pharmaceutical Development and Commercialization Inc., Princeton, USA

Abstract

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Objective:

To evaluate efficacy and safety of aripiprazole once-monthly 400mg (AOM-400mg), an extended release injectable suspension of aripiprazole, in obese (BMI =30kg/m2) and non-obese (BMI <30kg/m2) patients with schizophrenia.

Methods:

Data from a 38-week, double-blind, active-controlled, non-inferiority study (NCT00706654); randomisation (2:2:1) to AOM-400mg, oral aripiprazole (10-30mg/day) (ARI), or aripiprazole once-monthly 50mg (AOM-50mg) assessing the efficacy and safety of AOM in patients requiring chronic antipsychotic treatment were used for this post-hoc analysis. We report the overall relapse rates in the 38-week randomized phase. Comparisons of overall relapse rates were analyzed using the Chi-squared test.

Results:

662 patients were randomized to: AOM-400mg (n=265); ARI (n=266); or AOM-50mg (n=131). Of these, the following were obese: AOM- 400mg: n=95; ARI: n=95; AOM-50mg: n=43. In the obese patients, the overall relapse rate was significantly (p=0.0012) lower with AOM-400mg (7.4%) than with AOM-50mg (27.9%). The difference between AOM-400mg and ARI (8.4%) was not significantly different. In the non-obese patients, the overall relapse was significantly (p=0.0153) lower with AOM-400mg (8.8%) than with AOM-50mg (19.3%). The difference between AOM-400mg and ARI (7.6%) was not significantly different. For patients treated with AOM-400mg, the most common TEAEs (>10% in any group) are presented in Table 1.

Table 1.

TEAE: AOM-400mgObeseNon-obese
Insomnia12.6%11.2%
Headache12.6%8.2%
Injection site pain11.6%5.3%
Akathesia10.5%10.6%
Upper respiriatory tract infection10.5%<5%
Weight increase10.5%8.2%
Weight decrease6.3%11.8%

Conclusions:

The efficacy and tolerability of aripiprazole once-monthly 400mg were similar in both the obese and non-obese subgroups.

Disclosure:

Supported by Otsuka Pharmaceutical Development & Commercialization, Inc., and H. Lundbeck A/S

Type
EPW16 - Schizophrenia 2
Information
European Psychiatry , Volume 29 , Issue S1: Abstracts of the 22nd European Congress of Psychiatry , 2014 , pp. 1
Copyright
Copyright © European Psychiatric Association 2014
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