oxetine
(INDIANAPOLIS and INGELHEIM, Dec. 10 AsiaNet=연합뉴스)
Longest controlled duloxetine trial to-date showed significant advantages over
placebo
Duloxetine hydrochloride (Cymbalta(R)/Xeristar(R)), administered at 60 to
120 mg once daily, delayed the onset of a new episode of depression in patients
with recurrent depressive disorder, compared with placebo (p<.001), according
to new data from an international study presented at a meeting of a major
scientific society. Up to 85 percent of patients with depression experience
depressive recurrences(1).
Duloxetine is currently approved in Europe for the treatment of major
depressive episodes.
Results from the longest controlled duloxetine study to-date showed that,
during the trial's 52-week placebo-controlled maintenance phase,
duloxetine-treated patients (n=288) had a longer time to a depressive
recurrence, and were less likely to experience a new episode of depression
than the patients (n=226) who received placebo (recurrence rates were 14.4
percent vs. 33.1 percent, respectively).
A depressive episode is defined when a patient experiences at least five
(or more) of the following symptoms that have been present during the same 2-
week period and represent a change from previous functioning including
depressive mood, markedly diminished interest in activities most of the day,
significant weight loss, insomnia and increased tiredness in accordance with
the DSM-IV criteria for major depressive disorder (MDD)(2). The purpose of the
study was to understand whether the long-term use of duloxetine would prevent
the onset of new depressive episodes in patients with MDD who are at a high
risk of experiencing a depressive recurrence. Patients had to have experienced
at least 3 episodes of depression over the previous 5 years in order to be
eligible for the study.
Previous research has shown that many patients with depression will suffer
from multiple depressive episodes.(3) The number of episodes,(4) their
duration(5) and the presence of lingering depressive symptoms increase the
risk of recurrence, or future episodes of depression.(6) For those who
experience depression multiple times in their life, studies have shown that
the illness may cause structural changes in the brain,(7) making it more
difficult to treat over time.(7)
"Recurrent depressive episodes are detrimental to long-term health and
well being of patients," said Dr. Giuseppe Maina, University of Turin, Italy,
an investigator and an author on the study.
In the maintenance phase, which followed up to 34 weeks of open-label
treatment, the most common adverse events (those occurring in at least 5
percent of patients in any treatment group) were headache, insomnia,
dizziness, fatigue, back pain, common cold and flu. The results of the study
were similar between duloxetine and placebo-treated patients in the incidence
of any individual adverse event.
In addition to being approved for the treatment of major depressive
episodes, duloxetine is also approved in Europe for the treatment of
generalised anxiety disorder (GAD), diabetic peripheral neuropathic pain
(DPNP), and stress urinary incontinence (SUI).
Notes to Editors:
Additional Study Findings
-- Time to worsening of depressive symptoms was significantly longer in
the duloxetine treated group compared with the placebo-treated group.
This was defined as a 50 percent increase from baseline on the 17-item
Hamilton Rating Scale for Depression (HAMD17) total score and a
Clinical Global Impressions of Severity (CGI-S) score of 3 or more at
anytime during the maintenance phase.
-- Patients taking duloxetine experienced less worsening symptom severity
during the 52-week maintenance phase as measured by efficacy measures
including the HAMD17 total score and subscales, the CGI-S, and the
Patient's Global Impression of Improvement (PGI-I) scales, compared
with those taking placebo (p< .01).
-- Patients taking duloxetine experienced a similar worsening in somatic
symptom severity during the 52-week maintenance phase as measured by
Visual Analog Scales (VAS) for pain and the Symptom
Questionnaire-Somatic Subscale (SQ-SS), compared with those taking
placebo (p> .05).
Adverse Events
The proportion of duloxetine-treated patients who discontinued the study
due to adverse events during the acute, continuation and maintenance phases
was 6.6 percent, 6.1 percent and 4.1 percent, respectively. The following
were the most common treatment-emergent adverse events:
-- Acute phase: nausea, headache, dry mouth and excessive sweating
-- In addition, there was one person who did not complete the acute
phase due to a completed suicide, which was determined by study
investigators not to be attributed to treatment
-- Continuation phase: headache, common cold and excessive sweating
-- Maintenance phase: headache, back pain and common cold
Methods
The 52-week maintenance phase was preceded by up to 34-weeks of open-label
treatment with duloxetine 60-120 mg once daily. Of the 514 patients initially
entered into the study, 288 patients met response criteria at the end of up to
34 weeks treatment and entered the 52-week, double-blind, maintenance phase of
the study. Patients were randomly assigned to receive either duloxetine at
the dose to which they had previously responded or placebo during the
maintenance phase.
The primary endpoint of the study was time to recurrence of a major
depressive episode during 52 weeks of maintenance treatment, as assessed by
any of the following recurrence criteria: a CGI-S score greater than or equal
to 4 and meeting DSM-IV criteria for MDD; three consecutive visits meeting
re-emergence criteria or 10 total re-emergence visits; or study
discontinuation due to lack of efficacy. Secondary measures included the
HAMD17 total score and subscales, CGI-S and PGI-I scales, SQ-SS and VAS for
pain. Safety and tolerability were assessed via analysis of
treatment-emergent adverse events, vital signs, weight, ASEX for sexual
functioning, and laboratory measures. The primary study manuscript has
already been submitted for review with a view to publication in a
peer-reviewed medical journal.
About Major Depressive Disorder
Major Depressive Disorder (MDD) affects approximately 121 million people
worldwide.(8) The World Health Organization estimates depression will be
among the highest-ranking causes of disability in developed countries by 2020,
second only to ischemic heart disease worldwide.(8) It can happen to anyone of
any age, race or ethnicity; however, women are nearly twice as likely to
experience depression as men.(9) Complete elimination of symptoms, or
remission, is the primary goal of depression treatment. Treating the full
spectrum of emotional and physical symptoms to remission decreases a patient's
risk of relapse.(10)
About Duloxetine
While duloxetine's mechanism of action in humans is not fully known, it is
believed to affect both serotonin and norepinephrine/noradrenaline-mediated
nerve signaling in the brain and the spinal cord. Based on pre-clinical
studies, duloxetine is a reuptake inhibitor of serotonin and
norepinephrine/noradrenaline. Scientists believe its effect on mood and pain
perception is due to increasing the activity of serotonin and norepinephrine
in the central nervous system.
Duloxetine is approved for the treatment of major depressive disorder and
diabetic peripheral neuropathic pain in many countries and is also approved in
some countries for the treatment of stress urinary incontinence and
generalized anxiety disorder. Duloxetine is approved only for adults 18 and
over. There is a possibility of an increased risk of suicidal thoughts or
behavior in children and young adults treated with antidepressants. Patients
should call their doctor right away if they experience worsening depression
symptoms, unusual changes in behavior or thoughts of suicide, especially at
the beginning of treatment or after a change in dose.
Patients taking duloxetine may experience dizziness or fainting upon
standing. The most common side effects of duloxetine include:
-- For depression: Nausea, dry mouth, headache, insomnia, diarrhea
-- For diabetic peripheral neuropathic pain: Nausea, somnolence
(sleepiness), fatigue, headache, dizziness
-- For generalized anxiety disorder: Nausea, fatigue, dry mouth,
drowsiness, constipation, insomnia, decreased appetite, hyperhidrosis
(excessive perspiration), decreased libido, vomiting, ejaculation
delay and erectile dysfunction.
-- For stress urinary incontinence: Nausea, dry mouth, fatigue
This is not a complete list of side effects.
Duloxetine is contraindicated in patients who are allergic to it, who have
liver disease resulting in hepatic impairment, who are taking a monoamine
oxidase inhibitor (MAOI), fluvoxamine, ciprofloxacin or enoxacine or who have
severe kidney disease. The initiation of treatment with duloxetine also is
contraindicated in patients with uncontrolled hypertension that could expose
patients to a potential risk of hypertensive crisis.
Eli Lilly and Company and Boehringer Ingelheim
In November 2002, Eli Lilly and Company and Boehringer Ingelheim signed a
long-term agreement to jointly develop and commercialize duloxetine
hydrochloride. This partnership covers neuroscience indications in most
countries outside of the United States and Japan, with few exceptions.
About Eli Lilly and Company
Lilly, a leading innovation-driven corporation, is developing a growing
portfolio of best-in-class pharmaceutical products by applying the latest
research from its own worldwide laboratories and from collaborations with
eminent scientific organizations. Headquartered in Indianapolis, Ind., Lilly
provides answers -- through medicines and information -- for some of the
world's most urgent medical needs. For more information please visit
www.lilly.co.uk.
About Boehringer Ingelheim
The Boehringer Ingelheim group is one of the world's 20 leading
pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates
globally with 135 affiliates in 47 countries and almost 38,900 employees.
Since it was founded in 1885, the family-owned company has been committed to
researching, developing, manufacturing and marketing novel products of high
therapeutic value for human and veterinary medicine. In 2007, Boehringer
Ingelheim posted net sales of 10.9 billion euro while spending one fifth of
net sales in its largest business segment Prescription Medicines on research
and development. For more information please visit
www.boehringer-ingelheim.com.
Duloxetine for major depressive episodes, diabetic peripheral neuropathic
pain and generalized anxiety disorder is marketed by Lilly and Boehringer
Ingelheim in all countries included in the partnership under the brand name
Cymbalta(R), except for Greece, Italy and Spain. In Greece, Italy and Spain
Lilly markets the product as Cymbalta(R) and Boehringer Ingelheim markets the
product as Xeristar(R). In addition, in Germany, Lilly and Boehringer
Ingelheim market duloxetine for diabetic peripheral neuropathic pain as
Ariclaim(R). In the United States, Cymbalta(R) is marketed by Lilly and
Quintiles. In Japan, duloxetine is co-developed and co-marketed by Lilly and
Shionogi & Co., Ltd.
Duloxetine for stress urinary incontinence is marketed by Lilly under the
brand name Yentreve(R).
P-LLY
References
(1) Mueller TI, Leon AC, Keller MB, et al. Recurrence after recovery from
major depressive disorder during 15 years of observational follow-up." Am J
Psychiatry 1999;156:1000-1006.
(2) First Ml B. et al. DSM-IV-TR(R) Handbook of Differential Diagnosis.
American Psychiatric Publishing, Inc. 2002; 1-6
(3) Kessing LV. Recurrence in affective disorder: II. Effect of age and
gender. Br J Psychiatry 1998;172:29-34.
(4) Solomon DA, Keller MB, Leon AC, et al. Multiple recurrences of major
depressive disorder. Am J Psychiatry 2000;157:229-233
(5) Melartin TK, Rytsala HJ, Leskela US, et al. Severity and comorbidity
predict episode duration and recurrence of DSM-IV major depressive disorder. J
Clin Psychiatry 2004;65:810-819.
(6) Judd LL, Akiskal HS, Maser JD, et al. Major depressive disorder: a
prospective study of residual subthreshold depressive symptoms as predictor of
rapid relapse. J Affect Disord 1998;50:97-108
(7) Maletic, V., et al. Neurobiology of depression: an integrated view of
key findings. Int J Clin Pract 2007 Dec; 61(12):2030-40.
(8) World Health Organization. Factsheet - Depression, 2008. WHO.
Available at:
http://www.who.int/mental_health/management/depression/definition/en/.
Accessed on 21 November 2008
(9) American Psychiatric Association. Diagnostic and Statistical Manual of
Mental Disorders. 4th ed., Text Revision. Washington DC: American Psychiatric
Association; 2000:345-428.
(10) Paykel ES, Scott J, Teasdale JD, et al. Prevention of relapse in
residual depression an important outcome in depression. Psychol Med.
1995;25:1171- 1180.
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SOURCE: Eli Lilly and Company
CONTACT: Charles McAtee,
Eli Lilly and Company,
+1-317-271-1566;
or John Pugh,
Boehringer Ingelheim,
+ 49 (6132) 77-2964
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