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Bristol -Myers Squibb Company and Otsuka Pharmaceutical Co. Ltd

Long-Term Tolerability and Safety Data of ABILIFY(R) in Combination Treatment for Patients With Bipolar I Disorder

Florence, Italy (ots/PRNewswire)

- Results Presented Today at the Annual Congress of the World
Psychiatric Association (WPA)
ABILIFY(R) (aripiprazole), when used in combination with lithium
or valproate, is a generally well-tolerated long-term treatment for
patients with Bipolar I Disorder, who are partially non-responsive to
lithium or valproate monotherapy.(1) The data presented today at the
annual congress for the World Psychiatric Association (WPA) report a
favourable long-term safety profile for ABILIFY in combination with
lithium or valproate.(1)
Professor Eduard Vieta, lead study investigator and Professor of
Psychiatry and Director of the Bipolar Disorders Programme of the
Hospital Clinic at the University of Barcelona, Spain, said "As a
doctor, I value data on safety, tolerability and efficacy as
extremely important. Clinicians look for treatments that are
efficacious and tolerable in the long term. This study reports that
aripiprazole can provide Bipolar I Disorder patients with a
combination treatment option with the benefits of good long-term
safety and tolerability."
The efficacy and safety of ABILIFY, used in combination with
lithium or valproate for the treatment of patients with Bipolar I
Disorder, were investigated during a 6-week multicentre,
double-blind, randomized, placebo-controlled study involving 348
patients, followed by a 46-week open-label extension phase.
In total, 283 patients entered the extension phase of the study,
(prior placebo n=104 vs prior ABILIFY n=179).
The primary objective of the extension phase was to assess the
long-term safety and tolerability of ABILIFY in combination with
lithium or valproate. Patients in the study were followed up for an
additional 46 weeks.
The open-label extension data, presented at the WPA congress,
showed that ABILIFY, in combination with lithium or valproate,
continued to be well-tolerated with no new or unexpected adverse side
effects.
Evaluation of long-term efficacy was a secondary objective due to
the open-label nature of the extension phase. Since there was no
double-blind control, definitive statements regarding efficacy can
not be made, but results support that improvements in bipolar
symptoms were maintained through 52 weeks.(1)
The Young Mania Rating Scale (YMRS) Total Score and the Clinical
Global Impressions-Bipolar-Severity of illness (CGI-BP-S) (Mania)
Score continued to improve from the end of the double-blind phase to
week 52.1 Specifically, the YMRS Total Score (Last Observation
Carried Forward [LOCF]) continued to improve in both groups (-3.31
and -2.94 in patients receiving lithium and valproate, respectively.)
CGI-BP-S (Mania) Score (LOCF) also improved in both groups (-0.39 and
-0.57 in patients receiving lithium and valproate, respectively.).(1)
The results support previous clinical trials for ABILIFY, which
demonstrated efficacy and safety and overall improved quality of life
in patients with Bipolar I Disorder, when used as monotherapy. (2, 3)
Bipolar I Disorder is characterised by the occurrence of one or
more Manic Episodes or Mixed Episodes. A Manic Episode is defined by
a distinct period during which there is an abnormally and
persistently elevated, expansive, or irritable mood. The mood
disturbance must last for at least 1 week (unless hospitalisation is
required).
A Mixed Episode is characterised by a period of time (lasting at
least 1 week) in which the criteria are met both for a Manic Episode
and a Major Depressive Episode.(4) Untreated Manic Episodes generally
last three to six months and Depressive Episodes generally last six
to 12 months without treatment.(5)
Bipolar Disorder affects 2.4 million people in Europe.(6)
European Media Webcast - Minds and Hearts: Bipolar I Disorder
3 APRIL 2009, 10:00 CEST
You are invited to log onto a media webcast to view presentations
from leading European psychiatrists. Presentations will focus on
Bipolar I Disorder, the impact from a patient perspective and the
impact of treatment options. http://www.bipolar-1-disorder.com
Notes to Editors
About Bristol-Myers Squibb and Otsuka Pharmaceutical Co. Ltd
Bristol-Myers Squibb Company and Otsuka Pharmaceutical Co., Ltd.
are collaborative partners in the development and commercialisation
of ABILIFY(R). ABILIFY was discovered by Otsuka Pharmaceutical Co.,
Ltd. Founded in 1964, Otsuka Pharmaceutical Co., Ltd. is a healthcare
company with the mission statement: "Otsuka - people creating new
products for better health worldwide." Otsuka researches, develops,
manufactures and markets innovative, original products, focusing its
core businesses on pharmaceutical products for the treatment of
disease and consumer products for the maintenance of everyday health.
The Otsuka Pharmaceutical Group comprises 106 companies and employs
approximately 33,000 people in 18 countries and regions worldwide.
Bristol-Myers Squibb is a global biopharmaceutical whose mission
is to extend and enhance human life.
About ABILIFY(R) (aripiprazole) in schizophrenia
ABILIFY(R) (aripiprazole) is manufactured in 5 mg, 10 mg, 15 mg
and 30 mg tablets, 10 mg and 15 mg orodispersible tablets and 1 mg /
ml oral solution.
ABILIFY is currently indicated for the treatment of
schizophrenia; the current recommended dosing for ABILIFY in
schizophrenia is a once-daily dose. The recommended starting dose is
10mg or 15mg, with a maintenance dose of 15mg.
About ABILIFY(R) (aripiprazole) in Bipolar I Disorder
Manic Episodes:
The recommended starting dose for ABILIFY is 15 mg administered
on a once-a-day schedule without regard to meals as monotherapy or
combination therapy (see SmPC section 5.1). Some patients may benefit
from a higher dose. The maximum daily dose should not exceed 30 mg.
Recurrence prevention of Manic Episodes in Bipolar I Disorder:
For preventing recurrence of Manic Episodes in patients who have
been receiving ABILIFY, continue therapy at the same dose.
Adjustments of daily dosage, including dose reduction should be
considered on the basis of clinical status.
The Marketing Authorisation Application for ABILIFY in Europe is
supported by 8 Phase III clinical studies.
References
(1) Vieta E. et al. A 46 week evaluation of aripiprazole in
combination with lithium/valproate in bipolar mania. Poster # 131.
Presented at the annual congress of the World Psychiatric
Association, 2 April 2009.
(2) Keck P.E, Sanchez R, Torbeyns A et al. Aripiprazole
monotherapy in the treatment of acute bipolar I mania: a randomized,
placebo- and lithium-controlled study (CN138-135). Poster presented
at APA 160th Annual Meeting, San Diego, U.S., 19-27 May 2007.
(3) Dillenschneider A, Sanchez R, McQuade R.D, Torbeyns A.
Aripiprazole monotherapy in acute bipolar I mania: a randomized,
placebo- and haloperidol-controlled study (CN138-162). Poster
presented at WEBP, Strasbourg, France, 13-15 December, 2007.
(4) American Psychiatric Association 2000. (DSM-IV-TR) Diagnostic
and statistical manual of mental disorders, 4th edition, text
revision. Washington, DC: American Psychiatric Press, Inc. p320-323,
328-330, 333, 350-351.
(5) Royal College of Psychiatrists. Bipolar Disorder (Manic
Depression). http://www.rcpsych.ac.uk/mentalhealthinformation/mentalh
ealthproblems/bipolar manicdepression/bipolardisorder.aspx. Date
accessed 11 January 2007.
(6) Wittchen H-U, Jacobi F. Size and burden of mental disorders
in Europe - a critical review and appraisal of 27 studies. Eur
Neuropsychopharmacol 2005; 15:357-376.

Contact:

Contact: Carmel Hogan, Bristol-Myers Squibb Company, Mobile:
+33-6-74-10-76-58, carmel.hogan@bms.com.Alison Ross, Otsuka
Pharmaceutical Europe Ltd, Mobile: +44-(0)7768-337-128,
aross@otsuka-europe.com

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Plus de actualités: Bristol -Myers Squibb Company and Otsuka Pharmaceutical Co. Ltd