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(9/14/00 5:27 pm)
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Olanzapine Effective in Treatment of Mania
Olanzapine Shows Advantages in The Treatment of Acute Mania
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WESTPORT, Sep 13 (Reuters Health) - The antipsychotic agent olanzapine (Zyprexa, Lilly) may be more effective than valproate sodium (Depakote, Abbott) in treating acute mania associated with bipolar disorder.
The US Food and Drug Administration approved olanzapine as a short-term treatment of acute manic episodes associated with bipolar disorder in March of this year. The results of a study comparing olanzapine to valproate sodium, an anticonvulsant also approved for the treatment of acute mania, were presented at the 13th European College of Neuropsychopharmacology, in Munich, Germany, on Tuesday.
A total of 251 patients from 44 institutions received either 15 mg per day of olanzapine or 750 mg of valproate sodium. The primary outcome used to measure efficacy was the Young Mania Rating Scale (Y-MRS). According to Dr. Mauricio Tohen, medical advisor with Lilly Research Laboratories, patients' scores on the Y-MRS improved by 13 points with olanzapine and by 10 points with valproate sodium, and "this difference was statistically significant."
The study is part of an ongoing study that will compare the two drugs over the course of 12 months. "So far the results are derived from the first 3 weeks of the study — so what we have is the results of the acute treatment of mania," Dr. Tohen explained.
Olanzapine appeared to be superior to valproate sodium in improving symptoms related to motor activity, sleep disorder and language-thought disorder. In addition, remission of manic symptoms occurred in 47% of the patients receiving olanzapine, compared with 34% of the patients receiving valproate sodium.
However, olanzapine was associated with more side effects than was valproate sodium. Common side effects of olanzapine were somnolence, dry mouth and increased appetite. With valproate sodium, nausea was more frequent.
Dr. Tohen said that, "although there were more side effects with olanzapine, none of the side effects were considered to be clinically significant. In general, both drugs were well tolerated and appeared to be safe."
He added, "There was no statistically significant difference between the two agents with regard to extrapyramidal symptoms or other neurological symptoms like stiffness that are usually caused by antipsychotic agents."
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