Abstract
Objectives: The aim of this study was to compare the outcomes of olanzapine- and valproate-treated
patients in an observational study of acute mania with the results of a randomised
controlled trial (RCT) assessing the same treatments.
Methods: EMBLEM (European Mania in Bipolar Evaluation of Medication) was a 2-year, prospective,
observational study of health outcomes associated with the treatment of mania. Severity
of mania and depression were assessed at baseline and 6 weeks using the YMRS and the
5-item version of the HAMD, respectively.
Results: 621 patients were analysed (n=107 valproate, n=514 olanzapine). Both groups improved
from baseline to 6 weeks in mean YMRS and HAMD-5 total scores, with greater mean improvements
in the olanzapine compared with the valproate group. Olanzapine was associated with
more weight gain and less gastrointestinal difficulties than valproate.
Discussion: The EMBLEM results support those of the RCT, which suggest that olanzapine monotherapy
seems to be more effective than valproate monotherapy in the treatment of acute mania.
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Correspondence
D. Novick
Eli Lilly and Company
Lilly Research Centre
Erl Wood Manor
Sunninghill Road
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Surrey GU20 6PH
UK
Phone: +44/1276/48 38 32
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Email: Novick_diego@lilly.com