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Landmark Study Indicates Equivalent Effectiveness of Atypical Antipsychotics in the Treatment of First-Episode Psychosis
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VIENNA, AUSTRIA -- June 29, 2005 -- Preliminary results from the largest comparison of second generation antipsychotic drugs in first-episode psychosis patients, presented today at the 8th World Congress of Biological Psychiatry (WCBP), in Vienna, Austria, demonstrate that the atypical antipsychotics quetiapine, olanzapine and risperidone are equally effective as measured by all cause treatment discontinuation in first-episode psychosis. The study, known as CAF? (Comparison of Atypicals in First Episode Psychosis), is the first to examine the comparative effects of these three agents in this setting and provides clinicians with valuable insights into how to optimise atypical antipsychotic treatment in this important patient population.
Individuals suffering from first episode schizophrenia are typically young people who are at a stage in their lives where education, social interaction and personal development are extremely important. Large scale studies such as the CAF? trial, examining the clinical effectiveness of newer atypical antipsychotics, are therefore vital to ensuring improved patient outcomes in first episode patients.
The 52 week study conducted by the University of North Carolina1 (UNC) involving investigators across 26 sites in the US, compared quetiapine (mean modal dose 506 mg/day), olanzapine (mean modal dose 11.7 mg/day) and risperidone (mean modal dose 2.4 mg/day) in mostly treatment na?ve patients with schizophrenia, schizophreniform disorder, or schizoaffective disorder experiencing their first psychotic episode. All-cause treatment discontinuation was the primary endpoint of the study. The three medications had similar rates of discontinuation and in addition also achieved similar secondary efficacy outcome results as measured by commonly-used PANSS, CGI-S and CDRS scale scores. Most commonly reported side effects for all three medications were sleepiness and weight gain.
"Effectively treating first episode psychosis patients early in their course of illness can lead to superior treatment response and the ability to achieve symptomatic remission and successful outcomes. Accordingly, trials to help determine the best treatments in these patients are critical," commented Dr. Jeffrey Lieberman, CAF? Principal Investigator and Chairman of Psychiatry at Columbia University College of Physicians and Surgeons and Director of the New York State Psychiatric Institute. "CAF? is the first study of this size to compare multiple second generation antipsychotic drugs in first-episode patients. This study provides important new information on the comparative efficacy and safety of these medications that will guide clinicians in their care of these patients."
"These data underscore the importance of appropriate dosing for agents such as quetiapine in first-episode psychosis. In individuals with chronic schizophrenia, clinicians should fully explore even higher doses of medications, including quetiapine," added Dr. Lieberman.
Additional data presented at WCBP2 demonstrated that the recommended dose ranges obtained during drug registration trials do not necessarily match what is used in actual clinical practice settings once sufficient clinical experience has accumulated. Results from the study show that the mean daily dose of certain antipsychotics differ by as much as 100% from when the treatment was introduced to the present time. The study assessed information on 4,809 patients and their antipsychotic treatment from a New York State Office of Mental Health database, over a period running from 1997 to 2004. Among the patients prescribed SEROQUEL in the second quarter of 2004 (n=1086), the average daily dose was 620 mg. In the equivalent period in 1998, the average daily dose of SEROQUEL was significantly lower at (N=267) was 313.7 mg.
? The CAF? results announced at WCBP are primary endpoint results only; further results will be announced throughout 2005/2006.
? AstraZeneca has conducted the CAF? study in collaboration with the University of North Carolina (UNC).
? All-cause treatment discontinuation refers to all patients who discontinued their treatment for any non-administrative reason (e.g., family relocation).
SEROQUEL is a trademark of the AstraZeneca group of companies. For more information, please visit www.astrazenecapressoffice.com.
References:
1. Marx C. Comparison of Atypicals in First-Episode Psychosis ? a randomised, double-blind, 52-week comparison of olanzapine, risperidone and quetiapine. Presented at the 8th World Congress of Biological Psychiatry, Vienna, Austria, 2005.
2. Citrome L, Jaffe A, Levine J. Utilization and Dosing of First-Line Second-Generation Antipsychotics: Changes From 1997 to 2004. Abstract presented at the 8th World Congress of Biological Psychiatry, Vienna, Austria, 2005.
SOURCE: AstraZeneca



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