Posted by ChrisK on October 21, 2001, at 4:19:18
I don't have BPII so I don't usually follow the mania threads but I found this study interesting. It is from Medscape and discusses how Zyprexa treats manic episodes much more quickly and thouroughly than Depakote. I thought the doses were rather high but that may explain some of the reactions people in Babbleland may have found when taking Zyprexa.
http://psychiatry.medscape.com/MedscapeWire/2001/10/medwire.1018.Olanzapine.html
MedscapeWire
Olanzapine May Provide Better Control of Bipolar Mania
October 18, 2001--------------------------------------------------------------------------------
New York - New data show that olanzapine (Zyprexa; Lilly) may provide better control of mania and a faster time to remission compared with divalproex sodium (Depakote; Abbott) during treatment for manic or mixed episodes of bipolar disorder.
The study results were released last week at the American Psychiatric Association's 53rd annual Institute on Psychiatric Services. The study had the largest patient population and longest study period of any comparison of the 2 agents. Olanzapine is the only atypical antipsychotic that is indicated for the treatment of mania associated with bipolar disorder.
The 47-week, randomized, double-blind study examined 251 patients who met the DSM-IV criteria for a diagnosis of bipolar I disorder and were hospitalized with acute manic or mixed episodes. The study consisted of a 3-week acute phase study followed by a 44-week extension period (results from the 3-week acute phase of this study were released last year). A minimum score of 20 on the Young-Mania Rating Scale (Y-MRS), an 11-item scale used to assess the severity of a patient's mania, was required for inclusion.
Subjects received olanzapine (5-20 mg/day) or divalproex (500-2500 mg/day). The mean dose of olanzapine was 16.2 mg/day and the mean dose of divalproex was 1584.7 mg/day. The study's primary efficacy measure was the Y-MRS, and remission was defined by study protocol as a Y-MRS score of 12 or lower.
The study found that patients receiving olanzapine experienced significantly greater mania improvement, higher remission rates, and faster time to remission compared with patients receiving divalproex:
After 3 weeks of treatment, a greater proportion of olanzapine-treated patients achieved remission from manic symptoms compared with divalproex-treated patients (47.2% vs 34.1%, P=.039).Olanzapine-treated patients experienced remission significantly sooner than patients taking divalproex (P=.047). Median time to achieve remission was 14 days with olanzapine compared with 62 days for divalproex.
Throughout the study, olanzapine-treated patients had a greater improvement in mania compared with those receiving divalproex, with an average difference of 2.38 points on the Y-MRS (P=.002).
In addition, the study provided an opportunity to look at maintaining mania remission in those patients who had remitted during acute treatment. Divalproex-treated patients experienced numerically but not statistically higher mania relapse rates and shorter time to mania relapse:After remission, mania relapse rates between treatments during the 44-week continuation period were 50% with divalproex and 40.7% with olanzapine (P=.418).
Median time to mania relapse was 74 days for divalproex-treated patients compared with 270 days for olanzapine-treated patients (P=.325).
For all patients, treatment-emergent adverse events and laboratory abnormalities occurring more frequently with olanzapine (P< .05) were somnolence, dry mouth, increased appetite, weight gain, akathisia, and elevated liver function test. Adverse events and abnormalities occurring more frequently with divalproex (p< 0.05) were nausea, nervousness, manic reaction, rectal disorder, and decreased platelets.The pattern of weight gain differed between the treatments. Initially it was greater in the olanzapine group, but weight gain in patients receiving divalproex tended to catch up over time. Therefore, in an observed cases analysis, which includes only the patients remaining in the study at each time point, weight gain with olanzapine was significantly greater than with divalproex-treated patients from day 3 to week 15. However, by weeks 19 to 47, the amount of weight gained since the start of the study did not differ by treatment group. In contrast, in a last observation carried forward (LOCF) analysis, which includes patients who withdrew from the study early, mean weight gain from baseline to endpoint was 7.58 lbs with olanzapine and 3.79 lbs with divalproex (P=.045).
An estimated 3 million Americans have bipolar disorder, a chronic condition consisting of cycles of mania and depression. Symptoms of mania include abnormal elation or irritability, often accompanied by an unrealistic belief in one's own abilities, increased sex drive, delusions, and alcohol or drug abuse. People with bipolar disorder also may experience mixed episodes, marked by symptoms of mania and clinical depression occurring simultaneously.
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poster:ChrisK
thread:81849
URL: http://www.dr-bob.org/babble/20011015/msgs/81849.html