New Analysis Shows Duloxetine Reduced Anxiety Symptoms in Elderly Patients with Depression
25 May 2005 - 6:00AM
PR Newswire (US)
New Analysis Shows Duloxetine Reduced Anxiety Symptoms in Elderly
Patients with Depression Significant Reduction in Anxiety Symptoms
Seen as Early as One Week ATLANTA, Ga., May 24
/PRNewswire-FirstCall/ -- Duloxetine significantly reduced anxiety
symptoms in elderly patients with depression, compared with those
treated with a sugar pill, according to new research presented
today at the annual meeting of the American Psychiatric
Association. In the eight-week study of people over age 65 with
depression, 60 mg of duloxetine, taken once daily, significantly
reduced psychic anxiety symptoms in depressed patients, such as
worry, ability to concentrate, tension and irritability, compared
to placebo (mean change 6.2 vs. 0.18), as measured by the psychic
anxiety question on the Hamilton Depression Scale (HAMD17).
Duloxetine also significantly reduced somatic anxiety -- or
physical symptoms often associated with anxiety -- compared with
placebo (mean change of 1.88 vs. 0.99), according to the
anxiety/somatization subscale of the HAMD17. "When anxiety symptoms
appear in elderly patients with depression it often makes treatment
more complicated than when these symptoms emerge alone. This
comorbidity is associated with an increased severity of symptoms,
including a greater risk for suicide, and often less successful
treatment outcomes," explained Olga Brawman-Mintzer, MD, associate
professor of psychiatry, and the director of Anxiety Disorders
Program at the Medical University of South Carolina. While
depression alone affects two million Americans aged 65 and
older(i), there is considerable overlap between depression and
anxiety. Half of those with major depressive disorder actually meet
the criteria for an anxiety disorder. Furthermore, one-quarter of
those with anxiety disorders meet the criteria for major depressive
disorder(ii). "Since treating this population is so challenging,
the fact that patients responded to medication within one week
while on duloxetine is promising," stated Joel Raskin, MD, FRCPC,
medical advisor Eli Lilly and Company. "Further research into the
benefit of duloxetine in anxiety is needed." Additional Study
Highlights * When elderly patients were analyzed by age: - Patients
under 75 treated with duloxetine experienced significant
improvements in both psychic anxiety symptoms, such as worry and
tension, and physical anxiety symptoms, as measured by the
anxiety/somatization subscale, compared with those treated with a
sugar pill. - Patients 75 and older treated with duloxetine showed
significant improvements in psychic anxiety, as well. They also
showed a numerical advantage on the anxiety/somatization subscale
that was not statistically significant, as compared with those
treated with a sugar pill. * A statistically significant
improvement in the somatic anxiety item of the HAMD17 was not seen
in patients treated with duloxetine. * In this study, duloxetine
was safe and well tolerated, with discontinuations due to adverse
events occurring in less than 10 percent of those treated, with no
difference between duloxetine and placebo. * The most common
(>/= 5 percent) adverse events experienced by patients treated
with duloxetine in this study included dry mouth (14.5 percent),
nausea (12.6 percent), constipation (10.1 percent), headache (7.2
percent), dizziness (8.2 percent), diarrhea (8.2 percent), fatigue
(6.3 percent) and somnolence (5.3 percent). Methods Data were
gathered from 311 patients with major depression aged 65 and older
who participated in a multicenter, parallel, double-blind, placebo-
controlled study. After one week, patients were randomly chosen to
receive either duloxetine 60 mg once daily (n=207) or placebo
(n=104) for eight weeks. At the end of the study, patients entered
a one-week, double-blind discontinuation phase where the dose of
the study medication was tapered. A secondary analysis was
conducted to measure anxiety using anxiety items 10 (psychic) and
11 (somatic,) and the anxiety/somatization subscale of the HAMD17.
About duloxetine Serotonin and norepinephrine are two chemicals in
the brain and spinal cord called neurotransmitters. Serotonin and
norepinephrine are believed to both mediate core depression
symptoms and help regulate the perception of pain. Disturbances of
serotonin and/or norepinephrine may explain the presence of both
the emotional and physical symptoms of depression. Based on
pre-clinical studies, duloxetine is a balanced and potent reuptake
inhibitor of serotonin and norepinephrine. While the mechanism of
action of duloxetine is not fully known, scientists believe its
effect on both emotional symptoms and pain perception is caused by
increasing the activity of serotonin and norepinephrine in the
central nervous system. Duloxetine is approved in the United States
for the treatment of major depressive disorder and the management
of diabetic peripheral neuropathic pain, both in adults. Duloxetine
is not specifically indicated for geriatric depression. As
duloxetine has not been studied in children, Lilly discourages its
use in those under the age of 18. Important Safety Information In
clinical studies, antidepressants increased the risk of suicidal
thinking and behavior in children and adolescents with depression
and other psychiatric disorders. Anyone considering the use of
duloxetine or any other antidepressant in a child or adolescent
must balance the risk with the clinical need. Patients who are
starting therapy should be observed closely. Families and
caregivers should discuss with the doctor any observations of
worsening depression symptoms, suicidal thinking and behavior, or
unusual changes in behavior. Duloxetine is not approved for use in
patients under the age of 18. Patients on antidepressants and their
families or caregivers should watch for worsening depression
symptoms, unusual changes in behavior and thoughts of suicide, as
well as for anxiety, agitation, panic attacks, difficulty sleeping,
irritability, hostility, aggressiveness, impulsivity, restlessness,
or extreme hyperactivity. Call the doctor if you have thoughts of
suicide, or if any of these symptoms are severe or occur suddenly.
Be especially observant at the beginning of treatment or whenever
there is a change in dose. Prescription duloxetine is not for
everyone. People who are allergic to duloxetine or the other
ingredients in duloxetine should not take it. If you have recently
taken a type of antidepressant called a monoamine oxidase inhibitor
(MAOI), are taking thioridazine or have uncontrolled narrow-angle
glaucoma, you should not take duloxetine. Talk with your doctor
before taking duloxetine if you have liver or kidney problems,
glaucoma or consume large quantities of alcohol. Women who are
pregnant should talk with their doctor before taking duloxetine.
Nursing while taking duloxetine is not recommended. In clinical
studies of duloxetine for depression, the most common side effects
were nausea, dry mouth, constipation, decreased appetite, fatigue,
sleepiness, and increased sweating. Duloxetine is also approved for
the management of neuropathic pain associated with diabetic
peripheral neuropathy. In clinical studies of duloxetine in these
patients, the most common side effects were nausea, sleepiness,
dizziness, constipation, dry mouth, increased sweating, decreased
appetite, and loss of strength or energy. In all clinical trials,
most people were not bothered enough by side effects to stop taking
duloxetine. Your doctor may periodically check your blood pressure.
Don't stop taking duloxetine without talking to your doctor. For
full Patient Information, visit http://www.duloxetine.com/ . For
full Prescribing Information, including Boxed Warning, visit
http://www.duloxetine.com/. About Lilly Lilly, a leading
innovation-driven corporation, is developing a growing portfolio of
first-in-class and 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. Additional information about Lilly is
available at http://www.lilly.com/ . P-LLY This press release
contains forward-looking statements about the potential of
duloxetine hydrochloride for the treatment of anxiety, in addition
to major depressive disorder, and reflects Lilly's current beliefs.
However, as with any pharmaceutical product, there are substantial
risks and uncertainties in the process of development and
commercialization. There is no guarantee that the product will
prove to be commercially successful. For further discussion of
these and other risks and uncertainties, see Lilly's filings with
the United States Securities and Exchange Commission. Lilly
undertakes no duty to update forward-looking statements. (i) Kim,
Crystal. "Major Depression in the Elderly," Johns Hopkins
University, Spring 2003. Available at
http://www.jhu.edu/hurj/issue2/07C%20MajorDepress.pdf . Accessed
1/5/05. (ii) Anxiety Disorders Association of America. Brief
Overview of Anxiety Disorders. Available at:
http://www.adaa.org/AnxietyDisorderInfor/AnxietyElderly.cfm .
Accessed March 21, 2005. (Logo:
http://www.newscom.com/cgi-bin/prnh/20031219/LLYLOGO )
http://www.newscom.com/cgi-bin/prnh/20031219/LLYLOGO DATASOURCE:
Eli Lilly and Company CONTACT: David Shaffer (US), +1-317-651-3710,
cell: +1-317-332-9303, or Jennifer Yoder (OUS), +1-317-433-3445,
cell: +1-317-332-3145, both of Eli Lilly and Company
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