APA: Geodon (Ziprasidone HCl) Better Tolerated Than Zyprexa (Olanzapine) In Schizophrenia and Schizoaffective Disorders
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APA: Geodon (Ziprasidone HCl) Better Tolerated Than Zyprexa (Olanzapine) In Schizophrenia and Schizoaffective Disorders

NEW ORLEANS, LA -- May 8, 2001 -- Pfizer Inc's novel schizophrenia treatment Geodon (ziprasidone HCl) was shown to be significantly better tolerated in terms of weight gain, cholesterol, triglycerides and insulin levels than Zyprexa (olanzapine), another leading antipsychotic, according to data presented today at the annual meeting of the American Psychiatric Association. The study represents the first head-to-head comparison of the two medicines.

Results from a double-blind, six-week study involving 269 hospitalized patients showed that Geodon and Zyprexa were comparable in alleviating psychotic symptoms associated with schizophrenia and schizoaffective disorder. However, there were significant differences between the two medicines with regard to several important health parameters. Median weight gain for
patients treated with Geodon was less than one pound over the course of the study, while Zyprexa patients gained more than 10 pounds. Weight gain among Zyprexa-treated patients was progressive, with a median gain of over three pounds after only the first week of treatment.

"We know that weight gain has been a serious side effect of some antipsychotic treatments and that it can have a negative impact on patients' willingness to continue to take their medication," said Dr. Ira Glick, lead investigator and Professor of Psychiatry, Department of Psychiatry and Behavioral Sciences at Stanford University School of Medicine.

"Gaining a significant amount of weight carries its own set of health risks," Dr. Glick said. "Overweight or obese patients are more likely to suffer from a variety of cardiovascular problems and diabetes as well as have a reduced quality of life."

In addition, cholesterol and other lipid measurements were essentially unchanged throughout the study for Geodon patients while Zyprexa patients saw significant increases in these measures. Total cholesterol increased an average of 20 mg/dL for Zyprexa patients (from 185.6 at baseline to 206.4) while their triglycerides and low-density lipoprotein (or "bad" cholesterol) levels also rose significantly.

"These results are of potential clinical concern since such an increase in total cholesterol, based on epidemiologic studies, carries significant increased risks for adverse cardiovascular events," said Dr. Charles Hennekens, Visiting Professor of Medicine and Epidemiology and Public Health at the University of Miami School of Medicine and Associate Director for Cardiovascular Research at Mt. Sinai Medical Center-Miami Heart Institute. "Such large increases in cholesterol may even create a medical need for adding cholesterol-lowering intervention."

Insulin levels also rose significantly among patients treated with Zyprexa while there was no statistically significant change in insulin levels for Geodon-treated patients. Increased insulin levels suggest the development of insulin resistance.

Geodon, discovered and developed by Pfizer, was approved by the FDA on February 5, 2001. Most commonly reported side effects were somnolence, extrapyramidal symptoms and respiratory disorders (over 90 percent of which were identified as cold symptoms). Geodon is also associated with a small prolongation of the QTc interval of the electrocardiogram, an effect seen with certain other marketed medicines, including some antipsychotics. This effect was well characterized in the extensive Geodon clinical trials database and is reflected in the FDA's product labeling, which suggests that physicians use their best judgment, based on the overall status of the patient, as to whether Geodon or another antipsychotic agent be used first.

SOURCE: Pfizer Inc.

Related Link: Pfizer Inc.

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