Divalproex Sodium Versus Olanzapine in the Treatment of Acute Mania in Bipolar Disorder: Health-Related Quality of Life and Medical Cost Outcomes
Dennis A. Revicki, L. Clark Paramore, Kenneth W. Sommerville, Alan C. Swann, and John M. Zajecka, for the Depakote Comparator Study Group
J Clin Psychiatry 2003;64(3):288-294
© Copyright 2015 Physicians Postgraduate Press, Inc.
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Background: Divalproex sodium is a mood
stabilizer used in the United States for the treatment of acute
mania associated with bipolar disorder. Recently, olanzapine, an
atypical antipsychotic, was approved for the treatment of acute
mania. This study compares the clinical, health-related quality
of life (HRQL), and economic outcomes of divalproex and
olanzapine in the treatment of acute mania associated with
bipolar disorder.
Method: This 12-week, double-blind,
double-dummy, randomized clinical trial included 120 subjects
with DSM-IV bipolar disorder type I hospitalized for an acute
manic episode recruited from 21 U.S. clinical centers. Subjects
were randomly assigned to treatment with either divalproex or
olanzapine and were followed in hospital for up to 21 days. If
after 21 days clinical improvements (based on the Mania Rating
Scale [MRS]) were not observed, subjects were discontinued.
Subjects showing clinical improvement were treated for up to 12
weeks. HRQL was assessed using the Quality of Life Enjoyment and
Satisfaction Questionnaire (Q-LES-Q) after hospital discharge
(baseline) and at 6 and 12 weeks. Medical resource use and costs
were collected over the 12-week study.
Results: A total of 120 subjects (N = 63
divalproex, N = 57 olanzapine) were randomized, and 78 (65%) were
followed beyond 21 days. No statistically significant differences
between the treatment groups for baseline-to-endpoint MRS or
Q-LES-Q scores were observed. Total 12-week outpatient medical
costs were significantly lower for the divalproex-treated group
($541) compared with the olanzapine-treated group ($1080) (p =
.004). There was no significant difference in total medical costs
between the 2 groups (divalproex = $13,703; olanzapine = $15,180;
p = .88).
Conclusion: Divalproex is associated with
lower 12-week outpatient costs compared with olanzapine.
Divalproex and olanzapine have similar short-term effects on
clinical or HRQL outcomes in bipolar disorder subjects.