THERAPEUTIC POTENTIAL OF
SEROQUEL IN BIPOLAR DEPRESSIONDe: PR
Newswire Brasil
Para: THERESA CATHARINA DE GÓES CAMPOS
Assunto: BOLDER II Study Confirms Therapeutic
Potential of SEROQUEL In Bipolar Depression
21 de outubro de 2005 10:19 HORALOCAL
BOLDER II Study Confirms Therapeutic Potential
of SEROQUEL In Bipolar Depression
ALDERLEY PARK, England, Oct. 21 /PRNewswire/
-- Newly released top-line results from the
BOLDER II (BipOLar DEpRession) study have
underlined the potential for SEROQUEL (quetiapine
fumarate) in the treatment of patients with
major depressive episodes associated with
bipolar disorder. In BOLDER II, SEROQUEL 300mg
and 600mg doses achieved a statistically
significant reduction in levels of bipolar
depression compared with placebo (p is less than
or equal to 0.001), as measured by the change
from baseline in MADRS* total score(1). BOLDER
II, an eight week, multi-centre,
placebo-controlled study, reinforces the
findings of the landmark BOLDER I study(2)
published in American Journal of Psychiatry in
July 2005, which first indicated a significant
effect for SEROQUEL in treating major depressive
episodes associated with bipolar disorder.
In BOLDER II, the significant reduction in
MADRS total score was seen both in patients with
bipolar I and bipolar II disorder, in patients
with or without a rapid cycling course of
illness, and as early as week one after
randomisation. Significant improvements were
also seen compared with placebo in the various
secondary study endpoints among SEROQUEL-treated
patients, including reduction of anxiety
symptoms. In addition, more than half (53%) of
patients receiving SEROQUEL achieved remission**
from their bipolar depression symptoms.Importantly,
SEROQUEL was shown to be well tolerated in
BOLDER II with a similar safety profile seen to
that in BOLDER I. The rate of serious adverse
events was low and comparable in all treated
groups. The most common adverse events reported
in the trial were dry mouth, sedation,
somnolence, dizziness and constipation, and
there was a low incidence of treatment-emergent
mania in the SEROQUEL-treated groups. As in
BOLDER I, there was a low incidence of EPS (extrapyramidal
symptoms) and minimal weight change reported in
the study.
* MADRS (Montgomery- Asberg Depression Rating
Scale) measures the severity of a number of
depressive symptoms including mood and sadness,
tension, sleep, appetite, energy, concentration,
suicidal ideation and restlessness. The MADRS
score decreases as depression symptoms improve.
** Remission defined as a score of less than
12 on the MADRS scale (Montgomery-Asberg
Depression Rating Scale) at any point in time
during the study.
Professor Joseph Calabrese, co-director of
the National Institute of Mental Health Bipolar
Research Center at University Hospitals of
Cleveland and Case Western Reserve University
says: "Patients with bipolar depression are
underserved and understudied. The findings from
the BOLDER II study are very encouraging and
support the findings of BOLDER I, in showing the
potential of SEROQUEL, as monotherapy, for the
acute treatment for bipolar depression. Each of
these two studies represent the largest
placebo-controlled short-term studies ever
conducted in bipolar depression. The beneficial
risk:benefit profile of Seroquel seen in both
studies could offer an important therapeutic
value for both patients and physicians as we
currently have only one FDA-approved therapy to
treat depressive episodes associated with
bipolar disorder."
Bipolar disorder is a serious mental illness
that affects approximately 3-4% of the adult
population and is the sixth leading cause of
disability in the world.(3)(4)(5)(6) Patients
with bipolar disorder are symptomatic almost
half of their lives, and approximately
two-thirds of that time is spent in the
depressed phase of the illness.(7) Currently
SEROQUEL is only approved for the treatment of
mania associated with bipolar disorder. "BOLDER
II shows that SEROQUEL may provide substantial
clinical benefits to patients with bipolar
disorder", commented Carolyn Fitzsimons,
Seroquel Commercial VP. "Based on prior
discussions with the FDA and the results of
BOLDER II, AstraZeneca plans to file for a US
licence extension for SEROQUEL in the treatment
of depressive episodes associated with bipolar
disorder around the end of this year (2005)."SEROQUEL
has been licensed for the treatment of
schizophrenia since 1997 and is available in 85
countries for the treatment of this condition.
SEROQUEL is also licensed in 73 countries for
the treatment of mania associated with bipolar
disorder.
Notes to Editors
All product names appear in upper case.
SEROQUEL is a trademark of the AstraZeneca group
of companies.
SEROQUEL is currently not licensed for the
treatment of bipolar depression.
BOLDER II was an eight week, multi-centre,
placebo-controlled trial conducted in the US
which evaluated the efficacy of SEROQUEL (quetiapine)
treatment at doses of 300 or 600mg in over 500
patients with bipolar disorder experiencing
major depressive episodes. In BOLDER, the
primary endpoint for bipolar depression was
change in baseline on the MADRS (Montgomery-
Asberg Depression Rating Scale). Bipolar
depression and anxiety symptoms were assessed
using the MADRS, HAM-D (Hamilton Rating Scale
for Depression) and HAM-A (Hamilton Rating Scale
for Anxiety Scale).
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 $21.4 billion and leading
positions in sales of gastrointestinal,
cardiovascular, respiratory, oncology and
neuroscience products. AstraZeneca is listed in
the Dow Jones Sustainability Index (Global) as
well as the FTSE4Good Index.In Neuroscience,
AstraZeneca is dedicated to providing medicines
that have the potential to change patients'
lives. The company already markets several
products including SEROQUEL and ZOMIG. SEROQUEL,
which has proven efficacy and a very favourable
side effect profile, is the fastest growing of
the leading atypical antipsychotics and the
number one prescribed atypical in the United
States with global sales of $2 billion in 2004;
ZOMIG is a reliable migraine therapy and a
leader within the triptan market. The
Neuroscience pipeline includes leading
approaches for the treatment of depression and
anxiety, overactive bladder, dementia, stroke,
pain control and anaesthesia.
References:
1. BOLDER II study. AstraZeneca Data on File.
2. Calabrese JR et al. Am J Psychiatry
2005;162:1351-60.
3. American Psychiatric Association:
Diagnostic and Statistical Manual of Mental
Disorders, Fourth Edition, Text Revision.
Washington DC, American Psychiatric Association,
2000:385;395.
4. Hirschfield et al. Screening for bipolar
disorder in the community J Clin Psychiatry.
2003:64;53-59.
5. Lish JD, Dime-Meenan S, Whybrow PC et al.
The National Depressive and Manic-Depressive
Association (DMDA) survey of bipolar members. J
Affect Disord. 1994:31;281-294.
6. World Health Organization and the World
Bank. The Global Burden of Disease: Summary.
Cambridge, Mass: The Harvard School of Public
Health Harvard University Press, 1996.
7. Judd, Lll, Akiskal, HS, Schettler, PJ, et
al. The long-term natural history of the weekly
symptomatic status of bipolar disorder. Arch Gen
Psychiatry. 2002;59:530-537
SOURCE AstraZeneca
10/21/2005
CONTACT: Louise Marland, +44-1625-510782, Mobile:
+44-7900-607-794,
louise.marland@astrazeneca.com, or Julie
Saunders, +44-1625-231319,
Mobile: +44-7810-528-368, julie.saunders@astrazeneca.com,
both of
AstraZeneca; or http://www.astrazenecapressoffice.com
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