New Study Data Show Improved Cognitive Function in Elderly Patients Treated with Cymbalta for Depression

New Study Data Show Improved Cognitive Function in Elderly
Patients Treated with Cymbalta for Depression
Significant Improvements in Depressive Symptoms Seen as Early as One Week 


SAN DIEGO, March 7  /PRNewswire-FirstCall/ -- Elderly patients with depression
treated with Cymbalta(R) (duloxetine hydrochloride, pronounced sim- BAWL'-tuh),
60 mg once daily, had twice as much improvement in verbal learning and
recalling information than those given a sugar pill, according to new research
presented Saturday at the annual meeting of the American Association for
Geriatric Psychiatry.

By the end of the eight-week study, Cymbalta-treated patients demonstrated
significantly greater improvement in cognition when compared to patients
treated with a sugar pill (mean change 1.95 vs. .76).  Additionally, 27.4
percent of Cymbalta-treated patients were virtually free of their depressive
symptoms, a rate nearly double that seen with a sugar pill (14.7 percent).
Significant improvements in depressive symptoms in Cymbalta-treated patients
were also seen as early as one week.

Impairment of cognitive functioning is a bigger issue among the elderly with
depression than younger adults, one analysis suggests.(i)  It is not uncommon
for these patients to have short-term memory issues, like forgetting where they
placed their keys, or to experience a delay in recalling information.(ii)

"Treating and diagnosing depression in elderly patients can be complicated --
their condition presents differently from younger patients, making it more
difficult to diagnose, and their response to medication is less predictable,"
stated Alan Siegal, MD, associate clinical professor of psychiatry, Yale
University.  "Depression-related cognitive impairment, along with a greater
sensitivity to medication side effects, often make it more difficult for older
patients to comply with treatment recommendations."

Depression is a common illness among the aging, affecting two million Americans
aged 65 and older.(iii)  Often minimized by the patient and their doctor,(iv,v)
undiagnosed and untreated elderly depression leads to unnecessary pain and
suffering(vi) and increased healthcare costs.(vii)  The elderly are predisposed
to this condition for many reasons, including failing health, loss of loved
ones and frustration with memory loss.(viii)

"Previous clinical trials using other antidepressants in this patient
population showed cognitive dysfunction persisted even after the depression had
responded to treatment,"(ix) explained Joel Raskin, MD, FRCPC, medical advisor,
Eli Lilly and Company.  "In this study, significant improvements in both
cognition and depression were seen."

Additional study highlights

*  By 8 weeks, significantly more patients experienced a response in depressive
symptoms to treatment with Cymbalta than to a sugar pill (37.3 vs. 18.6
percent, respectively).

*  In comparison with those treated with a sugar pill, significantly fewer
Cymbalta-treated patients stopped treatment due to lack of efficacy (9.6 vs.
2.9 percent, respectively).

*  Discontinuation rates due to adverse events were similar for both treatment
groups (9.7 percent Cymbalta; 8.7 percent placebo).

*  The most common adverse events experienced by patients treated with Cymbalta
in this study included dry mouth (14.5 percent), nausea (12.6 percent),
constipation (10.1 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 aged 65 and older who participated in a
multicenter, double-blind, placebo-controlled study.  After a one-week
screening and a one-week, double-blind placebo phase, patients were randomly
chosen to receive either Cymbalta 60 mg once daily (n=207) or a sugar pill
(n=104) for eight weeks.

Patients then entered a one-week, double-blind discontinuation phase where the
dose of the study medication was tapered.

The primary outcome measure was a composite cognitive score based on four tests
that measured verbal learning and memory, selective attention and executive
functioning.  Secondary measures included the Geriatric Depression Scale and
the Hamilton Depression Scale (HAMD17).  Response in depression symptoms at
endpoint was defined as a greater than 50 percent decrease in the HAMD17 Total
Score from baseline.  Remission of depression symptoms at endpoint was defined
as a HAMD17 Total Score of less than 7.

About Cymbalta

Serotonin and norepinephrine are two neurotransmitters, or chemical messengers,
believed to help regulate a person's emotions and sensitivity to pain. 
Research suggests that increasing levels of serotonin and norepinephrine in the
brain and spinal cord can reduce the body's sensation of pain from the nerve
damage caused by diabetes.

Based on preclinical data, Cymbalta (pronounced sim-BAWL'-tuh) is a balanced
and potent reuptake inhibitor of serotonin and norepinephrine.(x)  It is
indicated in the United States for the treatment of major depression and the
management of diabetic peripheral neuropathic pain.  The European Commission
has also approved duloxetine for the treatment of major depression and
moderate-to-severe stress urinary incontinence in adults.  As duloxetine has
not been studied in children, Lilly discourages its use in those under 18.

Cymbalta should not be confused with Symbyax(TM) (pronounced SIMM-bee-ax), a
medicine for bipolar depression also marketed by Lilly.  Symbyax is a
combination of olanzapine, the active ingredient in Zyprexa(R), and fluoxetine,
the active ingredient in Prozac(R).  Symbyax is available in capsules of 6
mg/25 mg (olanzapine/fluoxetine), 12 mg/25 mg, 6 mg/50 mg and 12 mg/50 mg. 
Cymbalta is available in 20 mg, 30 mg and 60 mg capsules.

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 Cymbalta 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.  Cymbalta 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 are severe or occur suddenly.  Be especially observant at the beginning
of treatment or whenever there is a change in dose.

Prescription Cymbalta is not for everyone.  People who are allergic to
duloxetine hydrochloride or the other ingredients in Cymbalta 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 Cymbalta.  Talk with your doctor before
taking Cymbalta 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 Cymbalta.  Breast-feeding while taking Cymbalta is not
recommended.

In clinical studies of Cymbalta for depression, the most common side effects
were nausea, dry mouth, constipation, decreased appetite, fatigue, sleepiness,
and increased sweating.  Cymbalta also is approved for the management of
neuropathic pain associated with diabetic peripheral neuropathy. In clinical
studies of Cymbalta 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 Cymbalta.

Your doctor may periodically check your blood pressure.  Don't stop taking
Cymbalta without talking to your doctor.

For full prescribing information, including Boxed Warning, visit
http://www.cymbalta.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
Cymbalta for the treatment of cognition, 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)  Serby, Michael, et al.  "Overview:  Depression in the Elderly."  The Mount
Sinai Journal Of Medicine, Vol. 70 No. 1 January 2003.

(ii)  Maynard, Carolyn K. "Differentiate Depression From Dementia," The Nurse
Practitioner: The American Journal of Primary Health Care Vol. 28 No. 2 March
2003.

(iii)  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.

(iv)  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.

(v)  Birrer, Richard B, et al.  "Depression in Later Life: A Diagnostic and
Therapeutic Challenge." Am Fam Physician 2004;69:2375-82.
http://www.aafp.org/afp/20040515/2375.pdf

(vi)  Serby, Michael, et al.  "Overview:  Depression in the Elderly."  The
Mount Sinai Journal Of Medicine, Vol. 70 No. 1 January 2003.
(http://www.mssm.edu/msjournal/70/v70_1_page_39_44.pdf)

(vii)  Serby, Michael, et al.  "Overview:  Depression in the Elderly." The
Mount Sinai Journal Of Medicine, Vol. 70 No. 1 January 2003.
(http://www.mssm.edu/msjournal/70/v70_1_page_39_44.pdf)

(viii)  "Depression - Elderly." National Institutes of Health.  Available at
http://www.nlm.nih.gov/medlineplus/ency/article/001521.htm.  Accessed 1/14/04.

(ix)  Nebes RD, Pollock BG, Houck PR, Butters MA, Mulsant BH, Zmuda MD,
Reynolds CF 3rd. J Psychiatr Res. 2003 Mar-Apr;37(2):99-108

(x)  Bymaster F, Dreshfield-Ahmad L, Threlkeld P, Shaw J, Thompson B, Nelson D,
et al. Comparative affinity of duloxetine and venlafaxine for serotonin and
norepinephrine transporters in vitro and in vivo, human serotonin receptor
subtypes, and other neuronal receptors. Neuropsychopharmacology.
2001;25(6):871-880.

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DATASOURCE: Eli Lilly and Company



CONTACT:  Carole Witsken Puls (US), [phone], pager:

[phone], or Jennifer Yoder (OUS), [phone], pager:

[phone], both of Eli Lilly and Company



Web site: http://www.lilly.com/

http://www.cymbalta.com/ 

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