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PW01-36 - The Long-term Safety, Tolerability And Effectiveness Of Adjunctive Aripiprazole To Lithium/valproate In Bipolar i Patients Partially Non-responsive To Mood Stabilisers

Published online by Cambridge University Press:  17 April 2020

E. Vieta ,
R. Owen ,
C. Baudelet ,
R. McQuade ,
R. Sanchez ,
P. Fyans ,
J.-Y. Loze  and
R. Marcus
E. Vieta
Affiliation:
Clinical Institute of Neuroscience, Hospital Clinic, University of Barcelona, Barcelona, Spain
R. Owen
Affiliation:
Bristol-Myers Squibb, Wallingford, CT, USA
C. Baudelet
Affiliation:
Bristol-Myers Squibb, Braine-l’Alleud, Belgium
R. McQuade
Affiliation:
Otsuka Pharmaceutical Development & Commercialization Inc, Princetown, NJ, USA
R. Sanchez
Affiliation:
Otsuka Pharmaceutical Development & Commercialization Inc, Princetown, NJ, USA
P. Fyans
Affiliation:
Bristol-Myers Squibb, Uxbridge, UK
J.-Y. Loze
Affiliation:
Otsuka Pharmaceutical, Paris, France
R. Marcus
Affiliation:
Bristol-Myers Squibb, Wallingford, CT, USA

Abstract

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Objective

To evaluate the long-term tolerability and effectiveness of aripiprazole adjunctive to lithium or valproate in bipolar mania.

Methods

Completers of a 6-week double-blind comparison of adjunctive aripiprazole versus placebo in bipolar mania partially responsive to monotherapy were followed up over 46-weeks on open-label aripiprazole plus lithium (ARI+LI) or valproate (ARI+VAL).

Results

283 (ARI+LI n=108; ARI+VAL n=175) patients entered and 146 (ARI+LI n=55; ARI+VAL n=91) completed the 46-week extension. Safety results for both combinations were consistent with the known tolerability profile of aripiprazole, lithium and valproate. No clinically significant changes in lipids or glucose were observed with either ARI+LI or ARI+VAL. Mean (SE) weight change from double-blind endpoint to Week 46 (LOCF) was 2.3 (0.6) kg with ARI+LI and 2.0 (0.4) kg with ARI+VAL. Temporal analysis of the time of first onset of adverse events showed that akathisia and insomnia tended to occur early in treatment, with few new cases in patients previously treated with aripiprazole during the 6-week study.

Significant improvements from baseline in YMRS total score and MADRS total score were sustained over the 52 weeks with both ARI+LI and ARI+VAL treatment.

Mean reduction from baseline at Week 52 LOCF[95%CI], p value vs baselineARI+LIARI+VAL
YMRS total score-16.5 [-18.1; -14.8], p<0.001-17.6 [-18.9; -16.3] p<0.001
MADRS total score-1.7 [-3.3; -0.1] p<0.05-2.7 [-4.0; -1.4] p<0.001

Conclusions

Long-term aripiprazole adjunctive to lithium/valproate in bipolar mania was safe and well-tolerated. Improvements in manic and depressive symptoms observed during the first 6 weeks of treatment were maintained.

Type
Affective disorders / Unipolar depression / Bipolar disorder
Information
European Psychiatry , Volume 25 , Issue S1: 18th European Congress of Psychiatry. February 27, March 2, 2010 - Munich, Germany , 2010 , 25-E1438
Copyright
Copyright © European Psychiatric Association 2010
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