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NIMH-Funded Study Examines the Use of Antipsychotic Medications for the Treatment of Schizophrenia

Posted on: Monday, 19 September 2005, 12:00 CDT

WILMINGTON, Del., Sept. 19 /PRNewswire-FirstCall/ -- Results published in the New England Journal of Medicine from a National Institute of Mental Health-funded study compared the use of atypical antipsychotic medications, including SEROQUEL(R) (quetiapine fumarate), and a first generation antipsychotic medication for the treatment of schizophrenia. The study, titled Clinical Antipsychotic Trials of Intervention Effectiveness-Schizophrenia (CATIE-SZ), was a randomized, controlled study of 1,493 patients with schizophrenia.

"AstraZeneca appreciates the value CATIE-SZ adds to the body of evidence evaluating antipsychotic medication in schizophrenia. The study points to the importance of balancing the risks and benefits to patients when choosing an antipsychotic. The balance of efficacy and tolerability that SEROQUEL provides makes it an ideal choice in the treatment of schizophrenia," said Glenn Gormley, M.D., Ph.D., Chief Medical Officer, AstraZeneca. "The findings released represent the first of many anticipated study reports of this multi- phase study."

The authors noted that the high discontinuation rate (74%) provides evidence of the difficulties in treating individuals with schizophrenia. The most common reason for discontinuation was the patient's independent decision to stop treatment. "These findings emphasize the importance of patient- physician communication in maximizing treatment success," added Dr. Gormley.

"Schizophrenia and its treatment are both complex. Patients are unique and respond to different drugs in different ways. As a result, no one antipsychotic medicine is best suited for all patients, underscoring the need for multiple treatment options," said Dr. Gormley. "SEROQUEL provides significant benefits to patients with this complex and serious illness."

SEROQUEL is the #1 prescribed atypical in the United States(1) and has a well-established safety and efficacy profile. It is the only first line atypical with an extrapyramidal symptom (EPS) profile, including akathisia, no different from placebo across the dose range.(2)

For more information about SEROQUEL and schizophrenia, please visit http://www.schizophrenia-dialogue.com/.

ABOUT SCHIZOPHRENIA

Schizophrenia is a serious brain disorder with symptoms including distorted perceptions of reality, hallucinations and delusions, confused thinking, and flat or blunted emotions.(3) The first signs of schizophrenia typically emerge in the teenage years or early twenties.(3) Almost 2.2 million Americans - or 8 out of every 1,000 people - suffer from schizophrenia.(4) Medications are important in the management of symptoms.(5) Approximately 70 percent of patients with schizophrenia clearly improve when treated with antipsychotic drugs,(4) which are classified into two categories - "typical" and "atypical" antipsychotics.(4)

ABOUT SEROQUEL

SEROQUEL is an atypical antipsychotic approved for the treatment of acute manic episodes associated with bipolar I disorder and for the treatment of schizophrenia. In 2004, sales for SEROQUEL reached $2 billion. SEROQUEL has had more than 13 million patient exposures worldwide since its launch in 1997.

IMPORTANT SAFETY INFORMATION

SEROQUEL is indicated for the treatment of acute manic episodes associated with bipolar I disorder, as either monotherapy or adjunct therapy with lithium or divalproex, and the treatment of schizophrenia. Patients should be periodically reassessed to determine the need for continued treatment.

Elderly patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk (1.6 to 1.7 times) of death compared to placebo (4.5% vs. 2.6%, respectively). SEROQUEL is not approved for the treatment of patients with dementia-related psychosis.

Prescribing should be consistent with the need to minimize the risk of tardive dyskinesia. A rare condition referred to as neuroleptic malignant syndrome has been reported with this class of medications, including SEROQUEL.

Hyperglycemia, in some cases extreme and associated with ketoacidosis, hyperosmolar coma or death, has been reported in patients treated with atypical antipsychotics, including SEROQUEL. Patients starting treatment with atypical antipsychotics who have or are at risk for diabetes should undergo fasting blood glucose testing at the beginning of and during treatment. Patients who develop symptoms of hyperglycemia should also undergo fasting blood glucose testing.

Precautions include the risk of seizures, orthostatic hypotension and cataract development.

The most commonly observed adverse events associated with the use of SEROQUEL in clinical trials were somnolence, dry mouth, dizziness, constipation, asthenia, abdominal pain, postural hypotension, pharyngitis, SGPT increase, dyspepsia, and weight gain.

For full prescribing information for SEROQUEL, please visit the Web site http://www.seroquel.com/.

ABOUT ASTRAZENECA

AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services. It is one of the world's leading pharmaceutical companies with healthcare sales of over $21.4 billion and leading positions in sales of gastrointestinal, cardiovascular, respiratory, oncology and neuroscience products. In the United States, AstraZeneca is a $9.6 billion healthcare business with more than 12,000 employees. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4Good Index.

For more information about AstraZeneca, please visit: http://www.astrazeneca-us.com.

This press release contains forward-looking statements with respect to AstraZeneca's business. By their nature, forward-looking statements and forecasts involve risks and uncertainties because they relate to events and depend on circumstances that will occur in the future. There are a number of factors that could cause actual results and developments to differ materially. For a discussion of those risks and uncertainties, please see the company's Annual Report/Form 20-F for 2003.

(1) All atypical prescriptions: Total prescriptions. Jan. 05-Aug. 05. New prescriptions. Sept. 04-Aug 05. IMS Health. National Prescription Audit.

(2) Data on file, DA-SER-33.

(3) National Alliance for the Mentally Ill: "About Mental Illness/Schizophrenia" fact sheet. Reviewed by Daniel Weinberger, M.D.: October 2003.

(4) Torrey Fuller E. "Surviving Schizophrenia: A Manual for Families, Consumers, and Providers: Fourth Edition." New York: HarperCollins, 2001.

(5) Miller, Rachel and Susan E. Mason. "Diagnosis Schizophrenia: A Comprehensive Resource." New York: Columbia University Press, 2002.

AstraZeneca

CONTACT: Jim Minnick, AstraZeneca, +1-302-886-5135,jim.minnick@astrazeneca.com; or Lynn Gionta, AstraZeneca, +1-302-885-5672,lynn.gionta@astrazeneca.com

Web site: http://www.astrazeneca-us.com/http://www.schizophrenia-dialogue.com/http://www.seroquel.com/

Company News On-Call: http://www.prnewswire.com/comp/985887.html

Source: PRNewswire-FirstCall

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