Ziprasidone demonstrates fast onset of action in significantly reducing symptoms - Bipolar Disorder

10 мая, 2003
Bipolar patients who received Pfizer, Inc.'s atypical antipsychotic ziprasidone showed significant improvement in symptoms of acute mania compared with those who received placebo, according to new data. Drug Week via NewsEdge Corporation : Bipolar patients who received Pfizer, Inc.'s atypical antipsychotic ziprasidone showed significant improvement in symptoms of acute mania compared with those who received placebo, according to new data. Results from this randomized, double-blind, placebo-controlled study demonstrated that ziprasidone produced rapid, sustained improvements in manic symptoms when compared to placebo. Significant improvements were observed within 2 days of treatment and were maintained throughout the 3-week study. The study, which involved 210 inpatients, also demonstrated that after 7 days of treatment ziprasidone-treated patients showed significant improvement across all evaluation scales compared to those who took placebo, including symptoms of acute mania, psychosis and social functioning. It was published in the American Journal of Psychiatry. "Physicians are often looking for effective treatment options to help control the multiple symptoms of acute mania in patients who suffer from bipolar disorder," said Dr. Paul Keck, professor of psychiatry and pharmacology and vice chairman for research, department of psychiatry, University of Cincinnati College of Medicine. "This study suggests that ziprasidone may be a rapid and beneficial treatment option for bipolar mania." Bipolar disorder, which is also referred to as manic-depressive illness, is a serious form of mood disorder in which patients may experience extreme "highs," or manic episodes, and extreme "lows," or periods of major depression. The condition is estimated to affect 1 in every 100 Americans and has a major impact on the ability to function in daily life. Bipolar disorder is estimated to cost society about $45 billion per year. Patients in the midst of a period of mania, which usually lasts at least a week, may appear to be overly energetic, extremely expansive or excessively happy. They may have difficulty sleeping, functioning in social or work situations and may overindulge in pleasurable activities. The study was conducted in the United States and Brazil. Ziprasidone patients began taking 80 mg per day and were quickly titrated to 160 mg per day by the second day. Dosing was then flexible for the remainder of the study. Efficacy was measured using standardized psychiatric assessment scales. Among ziprasidone-treated patients, there was a low incidence of movement disorders, a side effect associated with some atypical antipsychotic medications and no clinically significant weight gain, changes in vital signs or other safety parameters (Keck PE Jr, Versiani M, Potkin S, et al. Ziprasidone in the treatment of acute bipolar mania: a three-week, placebo-controlled, double-blind, randomized trial. Am J Psychiatry, 2003;160(4):741-8). The most common side effects of ziprasidone in this study included somnolence, headache, dizziness, hypertonia, nausea and akathisia. Discovered and developed by Pfizer, ziprasidone is a serotonin and dopamine antagonist. The medicine was approved by the U.S. Food and Drug Administration in February 2001 for use in the treatment of schizophrenia. It also is approved in more than 45 countries worldwide. Ziprasidone received approval for the treatment of acute mania in Brazil in November 2002. Pfizer plans to file a supplemental new drug application FDA later this year for the treatment of acute mania. Ziprasidone is currently marketed as Geodon in the United Sates and in Brazil. This article was prepared by Drug Week editors from staff and other reports. <> << Copyright ©2003 NewsRx.com >>
Разделы
Новости