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Seroquel (Quetiapine Fumarate) Does Not Appear to Increase Risk of Cerebrovascular Adverse Events in Elderly Patients with Dementia

WILMINGTON, DE -- March 7, 2005 -- Data presented at the annual meeting of the American Association of Geriatric Psychiatry (AAGP) include results from a pooled analysis of two 10-week placebo- controlled trials that examined Seroquel® (quetiapine fumarate) in elderly patients with dementia. The results of a safety analysis, which was performed as a secondary endpoint and assessed the risk of cerebrovascular adverse events (CVAEs) in elderly patients taking Seroquel, were presented by Lon S. Schneider, M.D., professor of psychiatry, neurology, and gerontology, at the University of Southern California. These results suggest that Seroquel did not increase the risk of CVAEs in this group of patients. CVAEs are a side effect that have been associated with the use of some other atypical antipsychotics in this population.(1A)

"These results are potentially significant for the dementia population, but suggest that quetiapine be further investigated in clinical trials to assess safety and effectiveness," said Lon S. Schneider, M.D., professor of psychiatry, neurology, and gerontology, at the University of Southern California.

Results from the study were initially presented at the 9th International Conference on Alzheimer's Disease and Related Disorders in Philadelphia in July 2004. Seroquel is currently approved for the treatment of schizophrenia and the treatment of acute manic episodes associated with bipolar I disorder. Seroquel is not approved for treatment of patients with dementia-related psychosis. Since its approval in 1997, Seroquel has had over 8 million patient exposures worldwide.

CVAE Analysis

In the results from the safety analysis of CVAEs (mainly stroke and transient ischemic attacks), in the two 10-week, double-blind placebo- controlled trials, a total of 684 patients (mean age 83 years; 80% with Alzheimer's disease, 14% with vascular dementia, and 6% with other dementia types) were randomized to receive Seroquel, haloperidol or placebo. The numbers of patients who experienced CVAEs in this pooled data analysis were three in the Seroquel (0.8%) group, one in the haloperidol (0.9%) group, and four in the placebo group (1.9%).(1B) The CVAE analysis showed that Seroquel was not significantly different than placebo.

Important Safety Information About Seroquel

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. Patients should be periodically reassessed to determine the need for continued treatment.

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 website http://www.seroquel.com.


(1) Schneider L, Cerebrovascular Adverse Events and Quetiapine: A Pooled Analysis in Elderly Patients with Dementia. American Academy for Geriatric Psychiatry annual meeting, March 2005.


SOURCE: AstraZeneca

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