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PARKINSN  December 1998, Week 3

PARKINSN December 1998, Week 3

Subject:

SEROQUEL

From:

Keith Chancey <[log in to unmask]>

Reply-To:

Parkinson's Information Exchange <[log in to unmask]>

Date:

Thu, 17 Dec 1998 14:25:12 EST

Content-Type:

text/plain

Parts/Attachments:

Parts/Attachments

text/plain (170 lines)

Thought this would be of interest to the group:

Keith Chancey 46/15 months
Memphis, TN


New Hope For the Treatment of Alzheimer's and Parkinson's Diseases
SEROQUEL(R) (quetiapine fumarate) Tablets Shown to be an
Effective Treatment for Elderly Population

Date: Thursday, December 17, 1998
Source: PR Newswire


LAS CROABAS, Puerto Rico, Dec. 16 /PRNewswire/ via NewsEdge Corporation -- At
a time
when an increasing number of Americans are concerned about health problems
associated with aging, data presented today at a U.S. psychiatry conference
offer new hope for treating two of the most debilitating elderly illnesses.
(1)(2) SEROQUEL(R) (quetiapine fumarate) Tablets were associated with
improvements in patients with Parkinson's and Alzheimer's diseases, according
to the posters presented. Results came from two sub-analyses of a trial
conducted by Zeneca Pharmaceuticals to evaluate the short- and long-term
safety and tolerability of SEROQUEL in the treatment of elderly subjects with
selected idiopathic and organic psychoses.

The good news comes to the more than 80 percent of Americans who are concerned
about growing old, particularly due to the threat of Alzheimer's disease and
the decline in mental skills associated with aging.(3) An atypical
antipsychotic, SEROQUEL is indicated for the management of the manifestations
of psychotic disorders, including schizophrenia, and has also been shown to be
safe and effective in treating elderly patients with psychotic symptoms.(4)

"The use of SEROQUEL to treat these two very important patient populations
represents a critical advance in treating the elderly," said Lisa Arvanitis,
M.D., Senior Medical Director, Medical Research and Communications Group,
Zeneca Pharmaceuticals and an author of the study. "Our analyses indicate
SEROQUEL will become an important therapeutic option for both Parkinson's
disease and Alzheimer's disease -- adding to its already strong product
profile."

SEROQUEL Therapy May Reduce Hostility in Patients with Alzheimer's Disease

Approximately four million Americans are afflicted with Alzheimer's disease.
For the families of sufferers, hostility associated with the disease often
forces the painful decision to move a loved one into an institution. Standard
antipsychotics can reduce hostility in patients with Alzheimer's disease but
also may produce side effects such as extrapyramidal symptoms (EPS), which
include rigidity, cognitive dysfunction, or dysphoria. The results presented
here suggest that SEROQUEL treatment is associated with improvement in
hostility in patients with psychoses related to Alzheimer's.

Seventy-eight patients with Alzheimer's disease, 45 of whom had hostility,
showed significant
improvement in this one-year, open-label trial using SEROQUEL.(2)

SEROQUEL Therapy Improves Psychotic Symptoms Associated with Parkinson's
Disease

Another devastating condition associated with aging, Parkinson's disease
affects approximately 340,000 people, or one percent of the population over 65
years old, in the United States.(5) An exploratory analysis showed that
SEROQUEL is effective and well tolerated in patients with Parkinson's disease
and psychosis. The analysis also showed short-term improvement in patients'
motor performance which remains unexplained.

"Our analysis shows that SEROQUEL is an effective treatment for the psychotic
symptoms
associated with Parkinson's disease," said Paul Yeung, M.D., M.P.H., Associate
Medical Director, Clinical Medicine Group, Medical Research and Communications
Group, Zeneca Pharmaceuticals, and an author of the study. "We are also
encouraged by the initial improvement shown in motor performance and will
continue to explore the efficacy of SEROQUEL in this incapacitating
condition."

In the trial, from which both of these subanalyses came, the most common
adverse events reported in 184 patients were somnolence (31%), accidental
injury (21%) (most involved falls that investigators reported as not related
or probably not related to drug), and dizziness (17%). However, these side
effects were not necessarily related to the drug.

Americans Fear Aging

This data about SEROQUEL comes at a time when increasing numbers of Americans
are concerned about health problems associated with aging. A recent survey
conducted by Wirthlin Worldwide found that more Americans are very or somewhat
more concerned about Alzheimer's disease (81%) and decline in mental skills
(81%) than depression (67%). This research can offer new hope for treating
psychotic symptoms of these two common diseases associated with aging.

Background on SEROQUEL Tablets

Clinical trials with SEROQUEL have demonstrated efficacy in treating the
positive and negative symptoms of schizophrenia and were no different from
placebo across the clinical dose range in the incidence of extrapyramidal
symptoms (EPS), including rigidity and difficulty starting and stopping
movement, or elevation of plasma prolactin levels. In addition, studies have
shown that SEROQUEL exhibits a low incidence of hormonal, reproductive (sexual
dysfunction), and anticholinergic side effects (dry mouth, constipation).

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 Zeneca
Pharmaceuticals and is available by prescription in strengths of 25-mg,
100-mg, and 200-mg tablets. Since its approval in September of 1997, there
have been more than 346,000 prescriptions written for SEROQUEL for more than
112,000 patients.(6)(7)

The efficacy of SEROQUEL, as well as the atypical profile which distinguishes
the compound from standard antipsychotic agents, is supported by several
placebo- and comparator-controlled Phase II and III clinical trials in
patients hospitalized for acute exacerbation of chronic or subchronic
schizophrenia. SEROQUEL was well tolerated in more than 4,000 male and female
patients 18 years and older. SEROQUEL is comparable to placebo with regard to
safety. No blood monitoring is required.

As with other agents in its class, the labeling for SEROQUEL Tablets 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). Precautions include orthostatic hypotension. As with other
antipsychotics, SEROQUEL therapy 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 exhibited across placebo- controlled
trials included headache (19%), somnolence (18%), and dizziness (10%), and the
majority of events rated as mild or moderate. The safety and effectiveness of
SEROQUEL in pediatric patients (less than 18 years of age) have not been
established.

In the US, Zeneca Inc. is a $3.4 billion bioscience business with
approximately 7,500 employees. Zeneca Inc. is a wholly-owned subsidiary of the
UK-based Zeneca Group PLC (NYSE: ZEN), a major $8.6 billion international
bioscience business engaged in the research, development, manufacture, and
marketing of ethical (prescription) pharmaceuticals, agricultural and
specialty chemical products, and the supply of health care services.

NOTE: For full prescribing information for SEROQUEL Tablets, please visit the
US SEROQUEL web site at www.usa.zeneca.com/pharm/pibs/pib_seroquel.htm

(1) Juncos J, Yeung P, Sweitzer D, Arvanitis L, Nemeroff C. "Quetiapine
Improves Psychotic Symptoms Associated with Parkinson's Disease": Poster
presented at the 37th American College of Neuropsychopharmacology Annual
Meeting in Las Croabas, Puerto Rico, December 1998.

(2) Schneider L, Yeung P, Sweitzer D, Arvanitis L. "Quetiapine May Reduce
Hostility in Patients With Psychoses Related to Alzheimer's Disease":
Poster presented at the 37th American College of Neuropsychopharmacology
Annual Meeting in Las Croabas, Puerto Rico, December 1998.

(3) "Public's Concerns about Aging" survey conducted by Wirthlin
Worldwide, October 1998.

(4) Arvanitis L, Rak I, et al. "Efficacy, Safety and Tolerability of
SEROQUEL(R) (quetiapine fumarate) in Elderly Subjects with Psychotic
Disorders," Schizophrenia Research 1997; 24(1,2):196

(5) Berkow, R., ed. The Merck Manual, 16th Edition. New Jersey: Merck
Research Laboratories, 1992, 1495-1497.

(6) Source(TM) Prescription Audit (SPA) 13-Month Period Ending October
1998 and Month October 1998, Scott Levin, a division of PMSI Scott-Levin,
Inc.

(7) NDC Health Information Services, SEROQUEL Patient Tracking Analysis,
October, 1998.

SOURCE Zeneca Pharmaceuticals

/CONTACT: Jim Minnick of Zeneca Pharmaceuticals, 302-886-5135,
[log in to unmask] (ZEN)

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February 2003, Week 1
January 2003, Week 5
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December 2002, Week 5
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December 2000, Week 5
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December 1999, Week 5
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February 1998, Week 1
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December 1997, Week 5
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December 1997, Week 3
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December 1997, Week 1
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December 1995, Week 5
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