New Analysis Shows Duloxetine Reduced Anxiety Symptoms in Elderly Patients with Depression

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), [phone], cell: [phone], or

Jennifer Yoder (OUS), [phone], cell: [phone], both of Eli

Lilly and Company

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