Geodon Effective In Treating Schizophrenia Symptoms With A Postive Effect On Patients' Weight, Cholesterol And Triglycerides, Study Shows

(April 5, 2006) -- Pfizer today issued the following statement upon publication of results from the second phase of the National Institute of Mental Health (NIMH) study, Antipsychotic Trials of Intervention Effectiveness (CATIE), in patients with schizophrenia.

Phase II of CATIE evaluated treatment pathways of patients who discontinued treatment in phase I because their symptoms were not adequately controlled or they could not tolerate the medicine. Pfizer's Geodon® (ziprasidone HCL) was one of four medications evaluated in the tolerability pathway, which included patients who discontinued phase I due to intolerability or lack of efficacy.

“A significant finding in both phases of CATIE is that many patients with schizophrenia discontinued their treatment for a variety of reasons,” said Dr. Cathryn Clary, senior vice president, Pfizer medical. “CATIE highlights the need to have multiple treatment options and open access to these medicines so physicians can tailor a treatment that is both effective and tolerable to the individual patient.”

In phase II, Geodon was shown to be effective in treating symptoms of schizophrenia. In addition, patients taking Geodon experienced a decrease in weight and an improvement in metabolic parameters, including cholesterol and triglycerides. People with schizophrenia are more prone to obesity, elevated levels of cholesterol and diabetes, which pose a long-term cardiovascular risk.

The primary endpoint of the study was the length of time patients stayed on treatment, or time to discontinuation. Patients stayed on risperidone and olanzapine longer than quetiapine and ziprasidone.

“The doses of the medication used in CATIE may have affected how long patients stayed on their treatment,” said Clary. “Geodon was the only medicine dosed lower (116 mg/day) than the current average dose used by physicians (138 mg/day) while olanzapine and risperidone were used at higher than current average doses. Studies have demonstrated the effectiveness of Geodon at doses up to 160 mg a day. The right dose of medicine is critical to successful treatment of patients with this chronic and significant disease.”

The NIMH-funded CATIE study sought to evaluate and compare the long-term clinical effectiveness (efficacy and tolerability) of the newer, so-called atypical antipsychotics olanzapine, quetiapine, risperidone, and ziprasidone, and clozapine, an older antipsychotic, in treating schizophrenia.

About Geodon

Geodon was approved in the United States in February 2001 for the treatment of schizophrenia and in 2004 for acute bipolar mania, mania and mixed episodes. Geodon has been launched in 59 countries, with more than seven million prescriptions worldwide. It is widely accepted on hospital, Medicaid, national Veterans Administration, 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.

Physicians are currently instructed to dose Geodon at the lowest effective dose. The initial recommended dose is 40 mg a day, with a dose increase, as needed, after day three.

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.

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In short-term schizophrenia trials, the most commonly observed adverse events associated with Geodon at an incidence of >5% and at least twice the rate of placebo were somnolence and respiratory tract infection.

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.

Source: Pfizer Press Release

Last updated: 04/06

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