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Ziprasidone as Effective as Clozapine in Study of Difficult-to-Treat Patients With Schizophrenia

TORONTO, CANADA -- May 30, 2006 -- Results from a randomized, double-blind, 18-week study (called MOZART: Monitoring Oral Ziprasidone As Rescue Therapy in Neuroleptic-Resistant/Intolerant Patients), showed ziprasidone (Geodon®) to have comparable efficacy and better tolerability compared to clozapine in difficult to treat patients with schizophrenia.

The study was presented today at the annual American Psychiatric Association meeting.

Patients taking ziprasidone and clozapine showed similar improvements from baseline-to-endpoint on PANSS (Positive and Negative Syndrome Scale), a standard medical measurement of total symptom reduction in patients with schizophrenia. Significant improvement was observed for both medications from the first visit at day 11 and at all subsequent post-baseline visits.

"Clozapine is considered to be an effective medication for treating schizophrenia but is reserved for patients unresponsive to previous therapies, due to its potential for significant adverse events. Effective treatment options that are well tolerated are much needed in this population at every stage of treatment," said study author Emilio Sacchetti, MD, Chair of Psychiatry, Brescia University School of Medicine and Head of Department of Mental Health, Brescia Spedali Civili, Brescia, Italy.

Patients enrolled in MOZART met criteria for treatment resistance, defined as non-response in three or more adequate antipsychotic trials in the past five years and/or inability to tolerate antipsychotic treatment. Patients were randomized to 18 weeks of double-blind treatment with either ziprasidone 80-160 mg/d (n=73) or clozapine 250-600 mg/d (n=74). The average dose of ziprasidone used in MOZART was 130.4 mg/d. The average dose of clozapine was 345.7 mg/d.

Ziprasidone was also associated with more favorable metabolic effects than clozapine. "Results from this study show ziprasidone offers comparable efficacy to clozapine but with better tolerability for patients who have failed prior antipsychotic therapy." said Dr. Sacchetti.

Patients taking ziprasidone, compared to patients in the clozapine group, experienced significant reductions in median cholesterol levels (-5 vs. +2 mg/dL), LDL cholesterol (-6 vs. +4 mg/dL) and triglycerides (-15 vs. +10 mg/dL), with no change in fasting glucose (0 vs. +6 mg/dL) and weight loss (-5.7 vs. + 1.8 lbs).

People with schizophrenia have high rates of metabolic health disturbances such as serious weight gain, high blood pressure, diabetes and dyslipidemia. Abnormalities in these parameters can cause cardiovascular risks. Cardiovascular events are the leading cause of death among people with schizophrenia.

About Ziprasidone
Ziprasidone was approved in the United States in February 2001 for the treatment of schizophrenia and in 2004 for acute bipolar mania, manic and mixed episodes. Ziprasidone is available 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. Ziprasidone is not approved for the treatment of elderly patients with dementia-related psychosis.

Ziprasidone 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. Ziprasidone has a greater capacity to prolong the QTc interval than several antipsychotics. In some drugs, QT prolongation has been associated with torsades de pointe, a potentially fatal arrhythmia. In many cases this would lead to the conclusion that other drugs should be tried first.

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 ziprasidone, and it is not known if ziprasidone is associated with these events. Patients treated with an atypical antipsychotic should be monitored for symptoms of hyperglycemia.

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


SOURCE: Pfizer Inc.

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