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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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