Two Studies in Patients With Acute Bipolar Mania
Show Rapid and Significant Improvement in Patients Treated With Geodon(R)
A One-Year Extension Study Suggests Long-Term Benefits Without Weight
Gain, Higher Cholesterol or Triglyceride Levels
NEW YORK, May 5 -- Pfizer Inc's
Geodon (ziprasidone HCl) showed superiority to placebo in improving
manic symptoms and overall illness severity in acute
bipolar mania, according to data presented today at the American Psychiatric
Association (APA) 157th annual meeting. Onset of improvement in manic symptoms
was seen by day two in patients treated with Geodon.
In a pooled analysis of two, randomized, double-blind studies involving 415
hospitalized patients diagnosed with acute bipolar mania, improvement over a
three week study period was significantly greater and more rapid for Geodon
patients than those on placebo.
"Analysis of the pooled results shows that Geodon is equally effective in
treating a broad spectrum of patients with manic or
mixed episodes, as well as those with or without psychotic symptoms," said
Paul E. Keck, MD, professor of psychiatry and pharmacology and vice chairman for
research, Department of Psychiatry, University of Cincinnati College of
Medicine. "This is important new information for practitioners as well as
patients, who need effective treatment options for this complex illness."
Geodon-treated patients in the two randomized studies began taking daily
doses of 80 mg on day one, with an increase to 160 mg on day two in the first
study, and an increase to 120 mg on day two and 160 mg on day three permitted in
the second study. The most common side effects were somnolence, headache and
dizziness. Over the course of the three-week studies, Geodon was well tolerated,
with 11% of patients discontinuing due to treatment-related adverse effects.
Results from a one-year, open label extension study that included 127
patients support Geodon's longer-term efficacy and tolerability in these
patients. Concomitant medications were allowed during the one year extension
study. Patients were initiated on 80 mg per day at the start of the study, and
were then flexibly dosed up to 160 mg per day. The average dose of Geodon used
during the extension study was 122 mg per day. Further improvements in manic
symptoms (as assessed by the Mania Rating Scale and Clinical Global Impression)
were seen over the year of treatment with no observed increase in weight,
cholesterol, or triglycerides.
"The lack of weight gain, as well as no increase in cholesterol and
triglycerides, in this extended study is noteworthy and together with the
efficacy benefits suggest that Geodon may be a promising treatment option in the
long-term management of this disorder," Dr. Keck stated.
About Geodon
Approved in the United States in February of 2001 for the treatment of
schizophrenia, Geodon is licensed in 67 countries, and more than 3 million
prescriptions have been written worldwide. It is widely accepted on hospital,
Medicaid, national VA and managed care formularies. Geodon is the first atypical
antipsychotic approved in both capsule and IM formulations.
Discovered and developed by Pfizer, Geodon is a serotonin and dopamine
antagonist. In short-term trials, the most commonly observed side effects
associated with Geodon at an incidence of greater than or equal to 5 percent and
at least twice the rate of placebo were somnolence (14 percent vs. 7 percent),
respiratory distress (8 percent vs. 3 percent), of which more than 90 percent
were cold symptoms or upper respiratory infections, and EPS (5 percent vs. 1
percent).
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. In
some drugs, QT prolongation has been associated with torsade de pointes, a
potentially fatal arrhythmia. In many cases this would lead to the conclusion
that other drugs should be tried first.
Source: Pfizer Press Release
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