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Patients With Acute Bipolar Mania Show Rapid and Significant Improvement With Geodon (Ziprasidone HCl)

Geodon Improved Symptoms Within 2 Days, Was Well Tolerated

NEW YORK, NY -- August 9, 2005 -- Patients with bipolar mania experiencing manic or mixed (simultaneous symptoms of mania and depression) episodes showed significant improvements by day 2 of treatment with Pfizer Inc's Geodon^® (ziprasidone HCl), according to the findings from a multicenter study reported in the August issue of the Journal of Clinical Psychopharmacology.1

These findings confirm the rapid onset of efficacy and sustained improvement seen in a previous placebo-controlled study of Geodon in acute bipolar mania.2

In this study, Geodon was well tolerated. Treatment-related discontinuations due to adverse events were not significantly different for Geodon compared to placebo (5.8% vs. 1.5%, respectively, P = NS). Importantly, Geodon did not produce clinically significant increases in body weight, cholesterol and triglycerides, which are commonly seen with other atypical agents.

The 3-week, double-blind, placebo-controlled study involved patients with acute bipolar mania experiencing manic symptoms (including irritability, restlessness, high energy, and/or euphoria) with 40% of patients experiencing a mixed manic episode: simultaneous depressive symptoms (including sadness, crying, sense of worthlessness, loss of energy, loss of pleasure and/or sleep problems).

"A primary goal in treating acute bipolar mania is rapid symptom reduction, and our study shows that Geodon is effective in achieving that," said lead author Steven Potkin, MD, professor, Department of Psychiatry and Human Behavior, University of California, Irvine. "This is good news for practitioners as well as patients, who need fast and effective treatment options for this complex illness."

The study was a multicenter, double-blind, placebo-controlled trial involving 23 sites in the United States, Brazil and Mexico. A total of 206 patients experiencing manic or mixed episodes were given 21 days of treatment with either Geodon (beginning at 80 mg/d and flexibly dosed up to 160 mg/d) or placebo. The investigators assessed the patients at baseline and days 2, 4, 7, 14, and 21, or the last day of treatment for patients who discontinued early, using standard tests for bipolar disorder symptoms.

The findings showed that the average improvement, from baseline to the end of the 21-day study, was significantly greater for Geodon compared to placebo on the primary efficacy measure, a test called the Mania Rating Scale (MRS) (-11.1 vs. -5.6 points on this scale, respectively, p <.01). In addition, there were significantly more responders, defined as those demonstrating at least a 50% improvement (decrease) in MRS scores from the beginning to the end of the study, in the Geodon group than in the placebo group: 46% vs. 29% (P < .05).

Geodon was also associated with significantly greater improvements in other standard assessments, designated as secondary endpoints, including the Clinical Global Impression -- Severity (CGI-S) Scale (P < .001), Manic Syndrome (P < .01) and Behavior and Ideation Subscales (P <.001), Positive and Negative Syndrome Scale Total (P < .01) and Positive Subscale (p < 0.001), and Global Assessment of Functioning (P < .001).

The most common side effects were somnolence, headache, extrapyramidal syndrome and dizziness. There were no significant changes in either group from the beginning to the end of the study in median weight gain, serum triglyceride or serum cholesterol levels.

About Geodon

Approved in the United States in February 2001 for the treatment of schizophrenia and in 2004 for acute bipolar mania, Geodon is licensed in 73 countries, and more than 5 million prescriptions have been written worldwide. It is widely accepted on hospital, Medicaid, national Veterans Administration (VA) and managed care formularies.

Elderly patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk of death compared to placebo. Geodon is not approved for the treatment of elderly patients with dementia-related psychosis.

Geodon is contraindicated in patients with a known history of QT prolongation, recent acute myocardial infarction, or uncompensated heart failure, and should not be used with other QT-prolonging drugs.

Geodon has a greater capacity to prolong the QTc interval than several antipsychotics. With some drugs, QT prolongation has been associated with torsade de pointes, a potentially fatal arrhythmia.

Hyperglycemia related adverse events, sometimes serious, have been reported in patients treated with atypical antipsychotics. There have been few reports of hyperglycemia or diabetes in patients treated with Geodon, and it is not known if Geodon is associated with these events. Patients treated with an atypical antipsychotic should be monitored for symptoms of hyperglycemia.

Discovered and developed by Pfizer, Geodon is a serotonin and dopamine antagonist. The most common adverse events associated with Geodon in bipolar mania were somnolence, extrapyramidal symptoms, dizziness, akathisia, and abnormal vision.

REFERENCES:
1. Potkin SG, Keck PE Jr, Segal S, Ice K, English P. Ziprasidone in acute bipolar mania: a 21-day randomized, double-blind, placebo-controlled replication trial. J Clin Psychopharmacol Aug 2005; 25:1-10.
2. Keck PE Jr, Versiani M, Potkin S, et al, for the Ziprasidone in Mania Study Group. Ziprasidone in the treatment of acute bipolar mania: a three-week, placebo-controlled, double-blind, randomized trial. Am J Psychiatry 2003; 160:741–748.


SOURCE: Pfizer Inc.

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