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De: PR Newswire
Brasil
Para: THERESA CATHARINA DE GÓES CAMPOS
Assunto: Treating Both Poles of Bipolar Disorder:
Pivotal Study Confirms Potential of Quetiapine
as First Atypical Antipsychotic Monotherapy
23 de maio de 2006 16:10 HORALOCAL
Treating Both Poles of Bipolar Disorder: Pivotal
Study Confirms
Potential of Quetiapine as First Atypical
Antipsychotic Monotherapy
TORONTO, May 23 /PRNewswire/ -- The results of a
pivotal study
confirm the potential of quetiapine fumarate (SEROQUEL)
as a
monotherapy (treatment with a single
antipsychotic medicine) for
acute bipolar depression. Quetiapine is an
atypical anti-psychotic and
it is already established as an effective
treatment for
schizophrenia, and the manic phases of bipolar
disorder, but it is not
approved for bipolar depression.
From the first week of the BOLDER II (BipOLar
DEpRession) study,
improvements in the severity of depressive
symptoms (MADRS total
scores*) were significantly greater with
quetiapine 300 and 600 mg/d
than with placebo (week 1, change from baseline
with quetiapine 300
and 600 mg/d: -9.42 and -9.14, respectively;
both P<0.001 vs placebo:
-6.10) and the improvements continued during the
eight week study
(week 8, change from baseline with quetiapine
300 and 600 mg/d:
-16.94 and -16.00 respectively; both P<0.001 vs
placebo: -11.93. In
BOLDER II 509 patients were randomized to
treatment and 59% completed
the study. (1)
The data support the findings of the previously
reported BOLDER I
study(2) and together these two studies
represent one of the largest
placebo-controlled investigations ever conducted
for the acute
treatment of bipolar depression.
Bipolar disorder affects around 3-4 per cent of
the adult population
and is characterised by recurring periods of
mania and depression.(3)
Up to 56 per cent of people with bipolar
depression attempt suicide
and approximately 10 to 15 per cent commit
suicide.(4)
In an analysis of the BOLDER I and BOLDER II
data (1045 patients)(5)
suicidal thoughts (MADRS** item 10 score)
decreased significantly
more with quetiapine at both doses than with
placebo (week 8 scores,
300 mg/d: -0.98; P<0.001; 600 mg/d: -0.92;
P=0.001; vs placebo:
-0.64).
In a similar analysis of anxiety symptoms scores
(6), symptoms
improved significantly more in patients treated
with quetiapine at
both doses compared to placebo (HAM-A total
scores*** at week 1,
change from baseline, 300 mg/d: -4.59, P<0.001;
600 mg/d: -4.10,
P=0.003 vs placebo: -2.77; at week 8, change
from baseline, 300 mg/d:
-10.12 and 600 mg/d: -10.48; both P<0.001 vs
placebo: -6.88)(5).
In addition, a sub-group analysis of bipolar
disorder II patients
from the BOLDER I and BOLDER II studies found
that improvement in
severity of depressive symptoms (mean MADRS
total score*) from
baseline was significantly greater with
quetiapine 300 and 600 mg/d
than placebo, from the first assessment (Week 1)
through Week 8(7).
"Results from BOLDER II are remarkably similar
to those found in
BOLDER I, the first large-scale study that
examined SEROQUEL
treatment of depressive episodes in bipolar I
and II patients. The
replication of BOLDER I by BOLDER II adds
considerable strength to
the BOLDER data," said Michael E. Thase MD, of
the Department of
Psychiatry at University of Pittsburgh Medical
Center, USA and
principal investigator of BOLDER II. "In the
past, doctors have
typically treated bipolar disorder with both a
mood stabilizer and an
antidepressant. Having a single medication to
treat both the manic
and depressive episodes of this condition would
be a significant
medical advance."
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
said the fact that a
study on the scale of BOLDER II replicates the
findings of BOLDER I
so closely is both remarkable and exciting,
offering the hope of
similar consistency in the real-world setting.
"As a clinician, when you treat someone with
bipolar depression you
ask yourself -- what can I do to reduce the
chance of this person
committing suicide; how can I get symptoms under
control to give them
a better quality of life; and finally, will they
be satisfied with
the treatment and continue taking it? The
results of the BOLDER study
suggest that medical science can help us answer
these questions
better in the future."
Quetiapine was shown to be well tolerated and
the rate of serious
adverse events was low and comparable in all
treatment groups in both
studies. The most common adverse events reported
in the trial were
constipation, dizziness, dry mouth, sedation and
somnolence. In
BOLDER II rates of discontinuation due to
adverse events (AEs) were
8.1%, 11.2% and 1.2% on the 300mg and 600mg
quetiapine treatment
arms, and on placebo, respectively (1).
Quetiapine (quetiapine fumarate) has a
well-established safety and
efficacy profile and to date over 16 million
people have been treated
with quetiapine worldwide. Quetiapine has been
licensed for the
treatment of schizophrenia since 1997 and it is
available in 85
countries for the treatment of this condition.
Quetiapine is also
licensed in 73 countries for the treatment of
mania associated with
bipolar disorder. SEROQUEL(R) (quetiapine) is
marketed by AstraZeneca
and it is the number one prescribed atypical
antipsychotic in the
United States, with global sales of $2.8 billion
in 2005.
In December 2005, AstraZeneca submitted a
supplemental New Drug
Application (sNDA) to the US Food and Drug
Administration (FDA) to
seek approval for a new indication for SEROQUEL(R)
for the treatment
of patients with depressive episodes associated
with bipolar
disorder.
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 $23.95 billion and leading
positions in sales of
gastrointestinal, cardiovascular, neuroscience,
respiratory, oncology
and infection products. AstraZeneca is listed in
the Dow Jones
Sustainability Index (Global) as well as the
FTSE4Good Index.
For further information, please visit http://www.astrazeneca.com
or
http://www.astrazenecapressoffice.com. Further
information is also
available at the psychiatry resource Internet
site
http://www.psychiatry-in-practice.com .
Notes to Editors:
BOLDER I & BOLDER II are both eight week,
multi-centre, double-blind
placebo-controlled studies. Outpatients with
both bipolar I and II
disorder were randomised to receive eight weeks'
treatment with 300mg
or 600mg SEROQUEL or placebo, administered once
daily.
* Depression scores were measured by the
Montgomery-Asberg Depression
Rating Scale (MADRS), which 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.
** Suicidality was measured using MADRS item 10
("suicidal thoughts")
and Hamilton Rating Scale for Depression (HAM-D)
item 3 ("suicide")
scores.
*** Anxiety was measured using the Hamilton
Rating Scale for Anxiety
(HAM-A) scores.
References
(1) Thase M, McCoy R, Chang W, Macfadden W.
Efficacy of quetiapine
monotherapy in bipolar depression: a
confirmatory double-blind,
placebo controlled study (the BOLDER II Study).
Presented at the
American Psychiatric Association Annual Meeting,
Toronto, 2006.
(2) Calabrese JR, Keck PE, Macfadden W, et al,
for the BOLDER Study
Group. A randomized, double-blind,
placebo-controlled trial of
quetiapine in The treatment of bipolar I or II
depression. Am J
Psychiatry. 2005;162;1351-1360.
(3) Hirschfeld RMA, Calabrese JR, Weissman MM,
et al. Screening for
bipolar disorder in the community. J Clin
Psychiatry. 2003;64:53-59.
(4) Hawton, et al. Suicide and Attempted Suicide
in Bipolar Disorder:
A Symptomatic Review of Risk Factors. J Clin
Psychiatry.
2005;66:693-704.
(5) Macfadden W, Minkwitz, Spong E. Quetiapine
monotherapy
demonstrate efficacy in reducing suicidality in
bipolar depression.
Poster presented at the American Psychiatric
Association Annual
Meeting, Toronto, 2006.
(6) Lydiard BR, Raines S, Macfadden W.
Improvement in anxiety
symptoms in bipolar depression with quetiapine
monotherapy: results
from two placebo-controlled studies. Presented
at the American
Psychiatric Association Annual Meeting, Toronto,
2006.
(7) Hirschfeld RM, Suppes T, Vieta E et al.
Quetiapine monotherapy
for bipolar II depression: Pooled results from
two placebo-controlled
studies. Presented at the American Psychiatric
Association Annual
Meeting, Toronto, 2006.
SOURCE AstraZeneca
05/23/2006
CONTACT: James Read, AstraZeneca,
+1-302-885-9944, or mobile,
+1-302-750-7356, or James.Read@astrazeneca.com,
or Maren Koban of
Hill & Knowlton, +44-207-973-4497, or mobile,
+44-7713-631-514, or
mkoban@hillandknowlton.com
Web site:
http://www.astrazeneca.com
http://www.astrazenecapressoffice.com
http://www.psychiatry-in-practice.com
BNED: NG
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CORAL GABLES - MIAMI-US
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BRASIL-NÉLIA GARCIA
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