Researchers Report Improvement in Psychotic Symptoms and Cognitive Function
In Patients With Parkinson's Disease Following Treatment With SEROQUEL
SAN FRANCISCO, Feb. 26 /PRNewswire/ -- Results of a six month, open-label
study presented at the American Association for Geriatric Psychiatry (AAGP)
meeting (Feb. 23-26) suggested that SEROQUEL(R) (quetiapine fumarate) Tablets,
a product of AstraZeneca (NYSE: AZN), improves both cognitive and psychotic
symptoms in patients with Parkinson's disease and psychosis who failed
treatment with other atypical antipsychotic agents.(1) SEROQUEL is indicated
for the treatment of schizophrenia.
STUDY DESIGN
The single-center study examined the safety, tolerability, efficacy, and
cognitive effects of SEROQUEL in 29 patients with psychosis associated with
Parkinson's disease who had failed treatment with clozapine, risperidone, or
olanzapine due to lack of efficacy, intolerable side effects, or noncompliance
with blood monitoring. Patients received up to 400 mg/day of SEROQUEL, which
was dosed according to clinical response and tolerability for up to six
months.(1)
Psychiatric assessments included the Brief Psychiatric Rating Scale
(BPRS), the Clinical Global Impressions (CGI) Severity of Illness item, the
Neuropsychiatric Inventory sum of delusions and hallucinations (NPI-2), and
the Unified Parkinson's Disease Rating Scale (UPDRS) mental subscale and a
modified Hoehn and Yahr assessment. Assessments for Parkinson's disease
symptoms included the remaining UPDRS subscales. Cognitive function was
evaluated using measures of overall cognitive function, attention, and memory,
before and six months following the initiation of SEROQUEL therapy. Cognitive
performance in the SEROQUEL group was compared with that of a control group of
12 nonpsychotic patients with Parkinson's disease, with a test-retest interval
of approximately 1 year.(1)
RESULTS
SEROQUEL was associated with an improvement psychotic symptoms of patients
with Parkinson's. Study analyses revealed significant improvements in the
BPRS, CGI, NPI-2, and the UPDRS mental subscale.(1)
Moreover, the UPDRS motor subscale showed modest initial improvement that
was maintained throughout the trial.(1)
Significant improvement in memory was observed in patients with
Parkinson's disease and psychosis after 6 months of SEROQUEL therapy. When
compared with the nonpsychotic control group, patients with Parkinson's
disease and psychosis who received SEROQUEL treatment had statistically
significant improvements across time in sustained attention and immediate and
delayed memory.(1) No significant group differences were observed for overall
cognitive function or measures of simple attention.
"The results of this study are exciting for the countless families touched
by this crippling disease because they indicate that SEROQUEL may offer hope
for improving everyday cognitive functioning for patients with Parkinson's
disease and psychosis," said Vicki J. Roberts, Ph.D of Research conducted at
Emory University, Department of Neurology. "These results need to be further
investigated in placebo-controlled trials."
Only three patients withdrew due to Adverse Events and EPS adverse events
occurred infrequently.(1)
ABOUT PARKINSON'S DISEASE
Parkinson's disease, a progressive disorder of the central nervous system,
affects over 1 million people in the United States.(2) The disease is
characterized by a decrease in spontaneous movements, gait difficulty,
postural instability, rigidity and tremor.(2) Parkinson's disease is caused
by the degeneration of the pigmented neurons in the Substantia Nigra of the
brain, resulting in decreased dopamine availability.(2)
SEROQUEL TABLETS AND ASTRAZENECA
In studies supporting the approval of SEROQUEL(R) (quetiapine fumarate),
there were no differences from placebo across the clinical dose range in the
incidence of EPS, including rigidity and difficulty starting and stopping
movement, or in elevation of plasma prolactin levels. In addition, studies
have shown that SEROQUEL exhibits a low incidence of hormonal, reproductive
system (sexual dysfunction), and anticholinergic side effects (dry mouth,
constipation). The efficacy and atypical profile of SEROQUEL Tablets is
supported by several placebo-controlled Phase II and III clinical trials in
patients hospitalized for acute exacerbation of chronic or subchronic
schizophrenia. SEROQUEL was well tolerated by more than 4,000 male and female
patients 18 years and older in these trials. No blood monitoring is required.
In clinical trials, efficacy was demonstrated in a dose range of
150 mg/day to 750 mg/day. An initial target dose range of 300-400 mg can be
given in two divided doses daily. The drug is manufactured in the United
States by AstraZeneca and is available by prescription in strengths of 25-mg,
100-mg, 200-mg and 300-mg tablets. Since its approval in September of 1997,
there have been more than 3.2 million prescriptions written for SEROQUEL for
more than 851,000 patients in the United States.(3,4)
As with other agents in its class, the labeling for SEROQUEL includes a
warning relative to a rare condition known as tardive dyskinesia (which is
often associated with long-term use of antipsychotic agents) and neuroleptic
malignant syndrome (NMS symptoms include muscle rigidity, fever, and irregular
pulse). Labeling precautions include orthostatic hypotension and the possible
risk of cataract development. As with other antipsychotics, therapy with
SEROQUEL should be used cautiously in patients with a history of seizures or
with conditions that can potentially lower the seizure threshold. The most
common adverse events associated with taking SEROQUEL were dizziness (10%),
postural hypotension (7%), dry mouth (7%), and dyspepsia (6%) and the majority
of events were rated mild or moderate. The safety and effectiveness of
SEROQUEL in pediatric patients (less than 18 years of age) have not been
established.
AstraZeneca (NYSE: AZN) is a major international health care business
engaged in the research, development, manufacture, and marketing of ethical
(prescription) pharmaceuticals and the supply of health care services. It is
one of the top five pharmaceutical companies in the world with health care
sales of $15.8 billion and leading positions in sales of gastrointestinal,
oncology, anesthesia including pain management, cardiovascular, central
nervous system (CNS), and respiratory products. In the United States,
AstraZeneca is a $7.9 billion health care business with approximately
10,000 employees. For more information about AstraZeneca, please visit
http://www.astrazeneca-us.com.
NOTE: For full Prescribing Information for SEROQUEL Tablets, please visit
the US SEROQUEL web site at http://www.SEROQUEL.com, or call Jim Minnick at
302-886-5135.
(1) Juncos, JL, Robert VJ, Evatt ML et al, Poster presentation at the
American Association of Geriatric Psychiatry, San Francisco,
California, March, 2001.
(2) American Parkinson's Disease Association, 2000.
http//www.apdaparkinson.com
(3) NDC information services, IMS NPA for prescriptions, as of November
2000.
(4) NDC information services, study period through February
SOURCE AstraZeneca
