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. (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: Carole Witsken Puls (US),
+1-317-277-1421, pager: +1-888-431-8355, or Jennifer Yoder (OUS),
+1-317-433-3445, pager: +1-888-274-0289, both of Eli Lilly and
Company Web site: http://www.lilly.com/ http://www.cymbalta.com/
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