Study Examines SEROQUEL for the Treatment of Agitation in Elderly Patients with Dementia

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ProHealth.com • July 22, 2004

Study Examines SEROQUEL for the Treatment of Agitation in Elderly Patients with Dementia -- Study Results Suggest SEROQUEL May Reduce Symptoms of Agitation Associated With Dementia in Long-Term Care Patients; Analysis Shows No Evidence of an Increased Risk of Cerebrovascular Adverse Events -- WILMINGTON, Del., July 22 /PRNewswire-FirstCall/ -- AstraZeneca (NYSE: AZN) today announced data at the 9th International Conference on Alzheimer's Disease and Related Disorders that examined the effectiveness of SEROQUEL(R) (quetiapine fumarate) in the treatment of agitation in elderly patients with dementia. The data suggest SEROQUEL may reduce symptoms of agitation in elderly patients with dementia. The analysis also reported there was no evidence of an increased risk of cerebrovascular adverse events (CVAEs), which have been associated with the use of some other atypical antipsychotics in this population.(1) SEROQUEL is currently approved for the treatment of schizophrenia and for the short-term treatment of acute manic episodes associated with bipolar I disorder. Agitation in Elderly Dementia Patients In this 10-week double blind trial, a total of 333 patients with symptoms of agitation were randomized to receive either SEROQUEL 100mg/day, 200mg/day or placebo. Agitation symptoms were measured using the Positive and Negative Syndrome Scale-Excitement Component (PANSS-EC) measurement scale. In three separate analyses of PANSS-EC data conducted at the end of the study, patients taking 200 mg/day of SEROQUEL reported significantly greater reduction in PANSS-EC scores compared to those taking placebo (p<.05); and in a fourth analysis, the result approached statistical significance (p = 0.065). SEROQUEL 100 mg/day achieved numerically greater reductions in the PANSS-EC compared to that of placebo; however, the difference did not reach statistical significance. SEROQUEL was initiated at 25 mg/day on Day 1 and increased by 25 mg/day to reach a target dose of either 100 mg/day by Day 4 or 200 mg/day by Day 8.(1) The incidence of adverse events (AEs) and serious AEs were similar in each treatment group except for somnolence and sedation which were more common in the SEROQUEL groups. However, somnolence and sedation were rated mild to moderate in most patients. The incidence of falls and postural hypotension were also similar among the treatment groups. No cerebrovascular AEs were reported in either SEROQUEL group in this analysis. "Agitation is a significant issue for patients suffering from this condition and their caregivers. It is an aspect of dementia that is both difficult to manage and emotionally troubling for those who care for patients suffering from dementia," said Pierre Tariot, M.D., Professor of Psychiatry, Medicine and Neurology at the University of Rochester. "These new study results are helpful, informative, and justify further investigation of SEROQUEL for agitation in dementia patients." CVAE analysis AstraZeneca also announced results from an analysis of CVAEs (stroke and transient ischemic attacks) of two 10-week, double-blind placebo-controlled trials. A total of 684 patients (mean age 83 years, 86% with Alzheimer's Disease, 13% with vascular dementia, 1% 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 one in the SEROQUEL (0.3%) group, one in the haloperidol (0.9%) group, and four in the placebo group (1.9%).(2) "This is an important analysis that examines the incidence of CVAEs in elderly patients with dementia being treated with SEROQUEL," said Kate Zhong, Medical Director, AstraZeneca. "AstraZeneca has a clear commitment to the development of new treatments for mental illness, and is proud of how successful SEROQUEL has been since its launch in 1997." Since its launch, 27.4 million SEROQUEL prescriptions have been written for 6.8 million patients.(3) IMPORTANT SAFETY INFORMATION Prescribing should be consistent with the need to minimize the risk of tardive dyskinesia, seizures and orthostatic hypotension. A rare condition referred to as neuroleptic malignant syndrome has been reported with this class of medications, including SEROQUEL. There have been reports of diabetes mellitus and hyperglycemia-related adverse events associated with the use of atypical antipsychotics, including SEROQUEL. 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. The physician who elects to use SEROQUEL for extended periods of time should periodically re-evaluate the long-term usefulness of the drug for individual patients. For SEROQUEL full prescribing information, please visit 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 $18.8 billion and leading positions in sales of gastrointestinal, oncology, cardiovascular, neuroscience and respiratory products. In the United States, AstraZeneca is an $8.7 billion healthcare business with more than 11,000 employees. AstraZeneca is listed in the Dow Jones Sustainability Index (Global and European) as well as the FTSE4Good Index. For more information about AstraZeneca, please visit: http://www.astrazeneca-us.com. (1) Zhong K, Tariot P, Minkwitz MC, Devine NA, Mintzer J. Quetiapine for the treatment of agitation in the elderly institutionalized patients with dementia: a randomized, double blind trial. International Conference on Alzheimer's Disease and Related Disorders meeting, 2004, Poster # P2-442. (2) Schneider L, Zhong K, Tariot P, Minkwitz MC. Cerebrovascular adverse events and quetiapine: a pooled analysis in elderly patients with dementia. International Conference on Alzheimer's Disease and Related Disorders meeting, 2004, Poster # P2-443. (3) Data on File. SOURCE AstraZeneca Web Site: http://www.astrazeneca-us.com http://www.seroquel.com Company News On Call: Company News On-Call: http://www.prnewswire.com/comp/985887.html

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