MEDIA RELEASE PR35973
Further Evidence of Valdoxan(R) Superior Antidepressant Efficacy in Depressed
Patients
ISTANBUL, Sept. 15 /PRNewswire-AsiaNet/ --
Further evidence of the superior antidepressant efficacy of
Valdoxan(R)/Thymanax(R) (agomelatine) over conventional selective serotonin
reuptake inhibitors (SSRIs) and serotonin noradrenalin reuptake inhibitor
(SNRI) antidepressants was presented today at the Servier satellite symposium
on the occasion of the 22nd European College of Neuropsychopharmacology
(ECNP) Congress, with educational financial support provided by Servier. The
new data demonstrates superior antidepressant efficacy over the SSRI
fluoxetine, in severely depressed patients.[1]
This new data, in addition to the results of the international
development programme in over 6,000 patients and initial feedback from
countries in which it is launched, confirm that Valdoxan(R), the first
melatonergic antidepressant, has superior antidepressant efficacy at every
step of treatment in all depressed patients. This superior efficacy, combined
with a good tolerability profile makes Valdoxan(R) the first line treatment
of choice for depression, whatever the severity of disease.
"These results, coupled with the existing robust evidence on
the efficacy of Valdoxan(R), show that this new antidepressant offers an
important alternative for the treatment of depression, including in its
severe forms," says leading depression expert Professor Sidney Kennedy,
Psychiatrist-in-Chief of the University Health Network and Professor of
Psychiatry, University of Toronto, Canada. "Despite the availability of a
wide range of existing antidepressants, there are clear unmet needs in the
management of depression. Valdoxan(R), with its innovative mode of action,
represents a totally new approach to the management of Major Depressive
Disorder and will hopefully offer a brighter future for depressed patients."
New data[1]
The study was designed to demonstrate the superior
antidepressant efficacy of agomelatine compared to the SSRI fluoxetine, in
severely depressed patients. It was a randomised, multinational, double-blind
study carried out in 515 patients presenting with a current severe episode of
Major Depressive Disorder (MDD). Depression severity was defined on two
standard depression rating scales, the HAM-D17 and CGI-Severity of Illness.
To be included in the study, patients had to have a HAM-D17 score greater
than or equal to 25 combined with CGI-Severity of Illness score greater than
or equal to four.
Patients were split into two groups, receiving either
agomelatine 25 mg / 50 mg or fluoxetine 20 mg / 40 mg for an eight-week
period (adjustment to the higher dose of each drug was possible after two or
four weeks respectively).
Agomelatine antidepressant efficacy was significantly superior
to that of fluoxetine (P=0.024), with a difference between treatment in
favour of agomelatine at last post-baseline value of 1.49 point on HAM-D17.
The superiority of agomelatine compared to fluoxetine was also shown by
statistically significant higher percentages of responders on HAM-D17
(defined as a decrease from baseline total score greater than or equal to
50%) over the trial period 71.7% of the patients responded to treatment in
the agomelatine group compared to 63.8% in the fluoxetine group (P=0.060).
The superiority of agomelatine compared to fluoxetine was again shown on the
CGI-Improvement rating scale, a rating scale reflecting clinical judgement
and therefore daily clinical practice, with a statistically higher percentage
of responders (CGI-I score = 1 or 2; P=0.023) in the agomelatine group
(77.7%) than in the fluoxetine group (68.8%).
For those patients, the superior antidepressant efficacy of
Valdoxan(R) means a unique relief of depressive symptoms, as well as major
improvements in their professional, family and social life.
Valdoxan(R) international development programme
The efficacy of Valdoxan(R) in MDD has been shown in several
clinical trials within the international development programme. This
programme demonstrated the superior efficacy of Valdoxan(R) as compared with
placebo, SSRIs and SNRI treatments. Results of the studies showed that:
- Valdoxan(R) offers superior antidepressant efficacy in all
depressed patients, whatever the severity of depression[1]
- Valdoxan(R) offers superior antidepressant efficacy at every step of
depression treatment, showing superior patient improvement within the
first week of treatment, as reported by both physicians and patients
themselves[2],[3]
- Valdoxan(R) is effective against all the core symptoms of depression,
including depressed mood, anxiety, feeling of guilt, psychomotor
retardation, sleep disturbances, and daytime fatigue, leading depressed
patients to a more complete and sustained remission[4]
- Valdoxan(R) significantly reduces the incidence of relapse
in depressive patients over the long term[3]
- Valdoxan(R) preserves sexual functioning, is weight neutral and offers
a favourable tolerability profile, thus resulting in better
adherence and remission in depressed patients[5]
- Valdoxan(R) is easy to use: one 25 mg tablet taken at
bedtime, without discontinuation symptoms at the end of treatment[6]
Valdoxan(R): a major therapeutic advance in management of depression
through the restoration of circadian rhythms
Valdoxan(R) is the result of an advanced pharmacological
research programme involving investigation centres all around the world. It
is the first antidepressant that simultaneously acts as a MT1 and MT2
melatonergic receptors agonist and a 5-HT2C antagonist. As a result,
Valdoxan(R) resynchronises circadian rhythms that are profoundly disrupted in
depressed patients.[7]
"Valdoxan(R) has the potential to relieve the symptoms of
depression with a fast onset of action and reduced risk of significant
adverse effects," points out Doctor Philip Gorwood, Professor of Psychiatry
at Sainte Anne Hospital, Paris, France. "It has a novel mechanism of action
unlike those of the commonly-prescribed antidepressants, the SSRIs and SNRIs,
as Valdoxan(R) exerts its antidepressant efficacy without having an impact on
serotonin levels."
Valdoxan(R) was discovered and developed by Servier, France's leading
independent pharmaceutical company. Valdoxan(R) received EU marketing
authorisation in February 2009 and is now available in several countries
worldwide for the treatment of adult patients with MDD.
In accordance with point 25.5 of the ECNP congresses and pharmaceutical companies
guidelines (October 2008), the above statement does not reflect the opinions of the
ECNP.
Servier satellite symposium on the occasion of the 22nd ECNP Congress with
educational financial support provided by Servier.
Notes to editors
Major Depressive Disorder (MDD)
Major depressive disorder (MDD) - also known as unipolar depression -
is a common and disabling mental health disorder. Globally, MDD is
increasing in prevalence, affecting approximately 121 million people
worldwide, yet it remains under-diagnosed and under-treated.[8] Overall,
around 60 million Europeans currently suffer from some form of depression,
with an estimated 33.4 million of them suffering with severe depression.[9]
The World Health Organization (WHO) reported that depression was the fourth
leading cause of health-related disability, and has estimated that by 2020
depression will rank second only to heart disease as a worldwide cause of
disability.
For many patients, depression is a chronic and recurrent
illness. Nearly a third of patients with MDD are still depressed after one
year, and over 10% remain ill after five years. For those patients who
recover from a depressive episode, over a half will suffer a recurrence.[10]
References
1. Hale A, Corral R, Mencacci O, Saiz Ruiz J, Gentil V.
Superior efficacy of agomelatine vs fluoxetine in severe MDD
patients: a randomised, double-blind study
2. Kasper S, Laigle L, Bayle F. Eur Neuropsychopharmacol.
2008;18(suppl4):S336.Abstract P2c022.
3. Goodwin G, Rouillon F, Emsley R. Eur Neuropsychopharmacol.
2008;18(suppl4):S338. Abstract P2c025.
4. Lemoine P, Guilleminault C, Alvarez E. J Clin Psychiatry.
2007;68:1723-1732.
5. Kennedy SH, Rizvi S, Fulton K, Rasmussen J. J Clin
Psychopharmacol. 2008;28:329-333.
6. Montgomery SA, Kennedy SH, Burrows GD, Lejoyeux M,
Hindmarch I. Int Clin Psychopharmacol. 2004;19:271-280
7. Leproult R, Van Ondergergen A, L'Hermite-Baleriaux M, Van
Cautert E, Copinschi G. Clin Endocrinol. 2005;63:298-304.
(accessed 20 July 2009)
9. WHO Europe, Mental health in the WHO European Region Fact
sheet EURO/03/03, 8 September 2003
10. Prevalence, burden and diagnosis - Chapter One, Page One,
5 April 2007
SOURCE: Servier
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