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EPA-0790 – All-cause Discontinuation and Safety of Aripiprazole Once-Monthly for the Treatment of Schizophrenia: A Pooled Analysis of two Double-Blind, Randomized, Controlled Trials

Published online by Cambridge University Press:  15 April 2020

R. Baker ,
W.W. Fleischhacker ,
R. Sanchez ,
L.F. Tsai ,
T. Peters-Strickland ,
A. Eramo ,
D. Kostic  and
J. Kane
R. Baker
Affiliation:
CNS Global Medical Affairs, Otsuka Pharmaceutical Development and Commercialization Inc., Princeton, USA
W.W. Fleischhacker
Affiliation:
Biological Psychiatry Division, Medical University Innsbruck, Innsbruck, Austria
R. Sanchez
Affiliation:
Global Clinical Development (CNS), Otsuka Pharmaceutical Development and Commercialization Inc., Princeton, USA
L.F. Tsai
Affiliation:
Biostatistics, Otsuka Pharmaceutical Development and Commercialization Inc., Rockville, USA
T. Peters-Strickland
Affiliation:
Global Clinical Development (CNS), Otsuka Pharmaceutical Development and Commercialization Inc., Princeton, USA
A. Eramo
Affiliation:
Medical Affairs & Phase IV Clinical Affairs, H. Lundbeck A/S, Deerfield, USA
D. Kostic
Affiliation:
Senior Director Global Medical Affairs, Otsuka Pharmaceutical Development and Commercialization Inc., Princeton, USA
J. Kane
Affiliation:
Department of Psychiatry, Hofstra North Shore-LIJ School of Medicine, New York, USA

Abstract

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Objective:

To evaluate the initial (3 months) all-cause discontinuation and safety of aripiprazole once-monthly 400mg (AOM-400mg), an extended release injectable suspension of aripiprazole, stratified by previous treatment.

Methods:

These two studies (NCT00705783 & NCT00706654) were double-blind, placebo- or active-controlled assessing the efficacy and safety of AOM-400mg. Detailed study designs have been reported previously (1, 2). This analysis was conducted on the pooled population in the first 3 months after initiating AOM-400mg treatment, on patients who received at least one dose of AOM-400mg. Outcome measures are reported for groups stratified by prior treatment.

Results:

During the first 3 months of treatment, discontinuation due to all-causes (except for those who discontinued due to the sponsor stopping the NCT00705783 study early after pre-specified efficacy parameters were met) as well as due to adverse events are presented in Table 1. The rates of insomnia and akathisia are shown in Table 1

Conclusion:

Aripiprazole once-monthly 400mg appeared equally safe and effective (as measured by all cause discontinuation) in the first 3 months after initiation, regardless of treatment prior to entering trials.

Table 1Prior treatment
 Overall n=841Antipsychotic other than oral aripiprazole (converted) n=581Oral aripiprazole n=191Not on antipsychotic treatment n=69
All-cause discontinuations111/841 (13.2%)76/581 (13.1%)23/191 (12.0%)12/69 (17.4%)
Discontinuations due to adverse events21/841 (2.5%)14/581 (2.4%)3/191 (1.6%)4/69 (5.8%)
Insomnia71/841 (8.4%)57/581 (9.8%)6/191 (3.1%)8/69 (11.6%)
Akathisia59/841 (7.0%)39/581 (6.7%)15/191 (7.9%)5/69 (7.2%)

Type
E01 - e-Poster Oral Session 01: Schizophrenia
Information
European Psychiatry , Volume 29 , Issue S1: Abstracts of the 22nd European Congress of Psychiatry , 2014 , pp. 1
Copyright
Copyright © European Psychiatric Association 2014

References

Kane, JJ Clin Psychiatry 2012;73:617CrossRefGoogle Scholar
Fleischhacker. Poster presented at ACNP 2012.Google Scholar
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