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Head to Head Study Confirms Atypical Antipsychotic Efficacy Equivalence

Amsterdam, The Netherlands (ots/PRNewswire)

- New data also demonstrate SEROQUEL tolerability benefits versus
other atypicals in schizophrenia and reinforce therapeutic potential
in bipolar disorder
Seroquel (quetiapine), olanzapine and risperidone are equally
effective in patients experiencing first episode psychosis, according
to data presented today during the Breaking News session* at the
European College of Neuropsychopharmacology (ECNP) Congress.[1]
The CAFE (Comparison of Atypicals in First Episode Psychosis)
study is the first to examine the comparative effectiveness of
SEROQUEL, olanzapine and risperidone in first-episode psychosis
patients, as measured by all-cause treatment discontinuation. At week
52, the all-cause treatment discontinuation rates were similar
between medications (70.9 percent, 68.4 percent and 71.4 percent for
SEROQUEL, olanzapine and risperidone, respectively). However,
significantly more olanzapine patients (80 percent) experienced
weight gain of seven percent or more relative to baseline, compared
with 57.6 percent of risperidone and 50 percent of SEROQUEL patients
(P=0.01 olanzapine vs SEROQUEL).
Commenting on the data, Professor Henry Nasrallah, Professor of
Psychiatry, Neurology, & Neuroscience at the University of Cincinnati
Medical Center, USA said that the CAFE study shows the three
atypicals had similar rates of discontinuation and similar secondary
efficacy outcomes. "These data confirm that SEROQUEL, olanzapine and
risperidone show equivalent efficacy in the treatment of first
episode psychosis. In addition, they provide clinicians with further
guidance on the optimal dosing for agents such as SEROQUEL in first
episode treatment situations," Professor Nasrallah said.
The mean modal prescribed daily doses in CAFE were 506 mg for
SEROQUEL, 11.7 mg for olanzapine and 2.4 mg for risperidone. However,
Professor Nasrallah said it was important to remember that in chronic
schizophrenia, patients generally need higher doses of medication and
clinicians should explore the full dose ranges of medications.
The overall discontinuation rate observed among patients in this
study reflects the complexities in treating people with
schizophrenia, a severe mental illness which affects about one
percent of people.
"The study reinforces the need for a variety of medications so
that clinicians can find the best treatment option, with optimal risk
benefit ratio, for each patient. It also highlights how important
patient-physician communication is in maximizing treatment success,"
said Professor Nasrallah.
Other data presented at ECNP confirm that SEROQUEL (final mean
dose 709.8 mg) and risperidone (final mean dose 8.1 mg per day) are
equally effective in the acute management of schizophrenia, however
SEROQUEL offers tolerability benefits.[2] The results of the acute
phase of the TESIS study (Tolerability and Effectiveness of Seroquel
In Patients with Schizophrenia)* show that patients responded
similarly to both medications: 66.3 percent of SEROQUEL and 57.1
percent of risperidone patients showed at least 40 percent
improvement of Brief Psychiatric Rating Scale scores. More patients
experienced extrapyramidal side-effects (inability to control muscle
movements) with risperidone than with quetiapine: rigidity (25.7
percent vs 3.8 pecent, P<0.001), hypokinesia/akinesia (29.1 percent
vs 6.6 percent, P<0.001), tremor (22.7 percent vs 3.4 percent,
P<0.001) and akathisia (12.7 percent vs 1.9 percent, P<0.001). In
addition, quetiapine had less impact on male sexual functioning;
diminished sexual desire (18.8 percent vs 6.7 percent, P=0.012) and
erectile dysfunction (21.1.percent vs 5.9 percent, P=0.003) were more
common in males treated with risperidone compared to quetiapine.
SEROQUEL in bipolar disorder
Newly data presented at ECNP also evaluate SEROQUEL's therapeutic
potential in bipolar disorder. Top-line results from the BOLDER II
(BipOLar DEpRession) study, which will be presented at the
AstraZeneca satellite symposium on Monday 24 October, underline the
potential for SEROQUEL in the treatment of patients with major
depressive episodes associated with bipolar disorder[3]. In BOLDER
II, SEROQUEL 300mg and 600mg doses achieved a statistically
significant reduction in levels of bipolar depression compared with
placebo (p less than or equal to 0.001), as measured by the change
from baseline in Montgomery- Åsberg Depression Rating Scale (MADRS)
total score.[4]
BOLDER II, an eight week, multi-centre, placebo-controlled study,
reinforces the findings of the landmark BOLDER I study[5], which
first indicated a significant effect for SEROQUEL in treating major
depressive episodes associated with bipolar disorder.
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."
Results of a study by Carta et al* will also be presented at ECNP
and the results show that SEROQUEL is effective in the prevention of
both manic and depressive episodes in patients with bipolar disorder
who were not responding adequately to ongoing medications.[6] When
SEROQUEL was given for an average of 18.1 months as an additional
treatment, the relapse rate into manic or depressive episodes was
significantly reduced (P<0.001). This reduction was particularly
pronounced for depressive episodes: patients had an average relapse
rate of 0.05 depressive episodes per month prior to receiving
SEROQUEL, which was reduced to 0.01 episodes per month when taking
SEROQUEL (P<0.001).
The recent Thinking Ahead survey of people with bipolar disorder
showed that patients believe successful treatment would significantly
improve their quality of life and that they are looking for treatment
options offering efficacy and tolerability.
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, including the
US, Canada and several European countries. To date, approximately 13
million people have been treated with SEROQUEL worldwide.
SEROQUEL is a trademark of the AstraZeneca group of companies. For
further information about SEROQUEL, please visit
www.astrazenecapressoffice.com. Further information is also available
at the psychiatry resource internet site
www.psychiatry-in-practice.com.
*Notes to Editors:
  • The ECNP Breaking News session takes place from 18.00-19.15 in the poster area of The Amsterdam International Fairs & Congress Centre (RAI)
  • The TESIS study was a multicenter, prospective, non-randomized, comparative, naturalistic study. Patients >=18, who were admitted in an acute psychiatric unit, met DSM-IV criteria for schizophrenia, schizophreniform or schizoaffective disorder, and who, as part of the normal clinical practice, were prescribed QUE or RIS within first seven days after admission were included in a 3:1 ratio. A total of 436 patients were recruited to the study and 435 were considered evaluable, 323 in the QUE group and 112 in the RIS group.
  • The study by Carta et al involved 42 patients (22 males, mean age 42 +/- 18.0 years and 20 females, mean age 53 +/- 18.44 years), who were observed for an average of 9.5 months (range 3-18 months) before the addition of QTP at a mean daily dose of 535 +/- 54.5 mg. Patients were subsequently followed for an average of 18.1 months (range 6-42 months)
References:
[1] Comparison of Atypicals in First-Episode Psychosis - a
randomised, double-blind, 52-week comparison of olanzapine,
risperidone and quetiapine. Presented by R. Keefe. at the Breaking
News session at the 18th ECNP congress, The Netherlands, 2005
[2] Rico-Villademoros F. Tolerability and effectiveness of
Quetiapine in inpatients with schizophrenia: Results of the acute
phase of the TESIS Study. Poster presented at the 18th ECNP congress,
Amsterdam, The Netherlands, 2005.
[3] Bipolar disorder: a multidimensional illness requiring a
multifaceted approach. Satellite symposium at the 18th ECNP congress.
Amsterdam, The Netherlands, 2005.
[4] Data on file
[5] Calabrese JR et al. Am J Psychiatry 2005;162:1351-60.
[6] Carta et al. Quetiapine in long-term add-on therapy of
patients with bipolar I disorder inadequately responsive to
treatment. Poster presented at the 18th ECNP congress, Amsterdam, The
Netherlands, 2005.

Contact:

Alternatively please contact: Louise Marland, AstraZeneca, Tel:
+44-(0)-1625-510782 Mobile: +44-(0)-7900 607794 Email:
louise.marland@astrazeneca.com Lucy Turvill, Hill & Knowlton, Tel:
+44-(0)-20-7413-3508 Mobile: +44-(0)7810528368 Email:
lturvill@hillandknowlton.com

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