To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: Zyprexa Reduces Symptoms Of Mania, Severe Depression In Bipolar Disorder URL: http://www.pslgroup.com/dg/10981E.htm Doctor's Guide June 18, 1999
INDIANAPOLIS, IN -- June 18, 1999 -- New data presented today at the Third International Conference on Bipolar Disorder in Pittsburgh., PA, shows that Eli Lilly and Co.'s antipsychotic medication Zyprexa(R) (olanzapine) improved the symptoms of mania in patients with bipolar disorder. Moreover, these benefits were seen after only one week of therapy. This four-week, double-blind study involving 115 bipolar patients suffering a manic or mixed episode, with or without psychotic features demonstrated that olanzapine treated not only the manic symptoms, but also treated the symptoms of severe depression associated with mania. Overall, 65 percent of olanzapine-treated patients showed a 50 percent or greater improvement compared with 42 percent of placebo-treated patients. The results from this study suggest that olanzapine may have mood stabilising properties and the potential to be used as monotherapy for bipolar disorder. Bipolar disorder, also known as manic depressive illness, affects approximately one to two percent of the world's population. Individuals with the disorder experience debilitating swings in mood from manic episodes, marked by abnormal euphoria and irritability, to periods of depression. These symptoms may have a detrimental impact on a person's well-being and quality of life and can be devastating for sufferers and their families. An estimated one in four persons with bipolar disorder attempts suicide. Currently, no single agent has been approved for marketing by the U.S. Food and Drug Administration as monotherapy to treat all stages of bipolar disorder. Commonly-used medications to treat the disorder include lithium, anticonvulsants, antidepressants and antipsychotics. The speed with which these drugs work varies. Lithium, a commonly used mood stabiliser, is estimated to take between 10 to 14 days to begin working. "Psychiatrists have to rely on many therapies to manage patients with bipolar disorder," said Dr. Susan McElroy, professor of psychiatry, University of Cincinnati, College of Medicine. "They and their patients have to deal with the accompanying titration and blood monitoring associated with these agents and, as a consequence of such polypharmacy, the potential for drug interactions must also be considered. "These new data highlight olanzapine's efficacy in controlling manic symptoms and rapid onset of action, the potential benefits of which may be reaped by both patients and their psychiatrists." The placebo-controlled study took place at 26 U.S.-based study sites involving 115 patients with a diagnosis of bipolar disorder, currently displaying an acute manic or mixed episode with or without psychotic features. Dosing ranges of olanzapine were 5 to 20 mg/day, with a starting dose of 15 mg/day. All patients met the DSM-IV diagnosis of bipolar I disorder currently displaying an acute manic or mixed episode and were required to have a baseline Young-Mania Rating Scale (Y-MRS) total score greater than or equal to 20. Patients' manic, depressive and overall symptoms were rated at weekly intervals using several standard psychiatric measurement tools, specifically the Y-MRS, CGI-BP Severity, Positive and Negative Syndrome Scale (PANSS), and Hamilton-Depression Rating (HAM-D) scales. The key findings of the study were that: -- Patients assigned to olanzapine experienced a statistically significant improvement in mania after only one week of therapy and this significance continued throughout the study, as measured by the Y-MRS. -- Patients assigned to olanzapine experienced a statistically significant improvement in elevated mood, the core symptom of mania, defined by analysis of Y-MRS. -- Manic patients assigned to olanzapine also presenting with severe depression as measured by HAM-D (total score greater than 20) experienced a statistically-significantly greater mean improvement in depressive symptoms compared with patients assigned to placebo (-12.29, olanzapine; -6.81, placebo). Olanzapine-treated patients had a statistically significantly greater mean improvement in their overall mania symptoms, regardless of whether psychotic features were present. Somnolence occurred at a statistically higher rate in olanzapine-treated patients compared with placebo-treated patients in this study (38.2 percent versus 8.3 percent). Additionally, statistically significant difference in mean weight gain was also observed between olanzapine- and placebo-treated patients (2.11kg versus 0.45kg). Sixty-two percent of patients taking olanzapine completed the study whereas 42 percent of the placebo group did. Olanzapine is marketed globally as Zyprexa and is indicated in the United States for the management of the manifestations of psychotic disorders as demonstrated in clinical trials with schizophrenia patients. Since olanzapine was introduced in 1996, it has been prescribed for more than 2.8 million people world-wide. In the original registration trials, olanzapine was generally well-tolerated. However, as with all antipsychotics, olanzapine was associated with some side effects. In the original six-week, acute-phase trials, the most common treatment-emergent adverse event associated with olanzapine was somnolence. Other common events were dizziness, weight gain, personality disorder, constipation, akathisia and postural hypotension. Modest elevations of prolactin were also seen, although mean changes from baseline to endpoint were not statistically significantly different between olanzapine and placebo. A small number of patients experienced asymptomatic elevations of hepatic transaminase. None of these patients developed jaundice or drug-induced hepatitis. Related Link: Zyprexa, Eli Lilly and Co. --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. 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