New Analysis Shows Cymbalta Reduced Anxiety Symptoms in Elderly Patients with Depression
May 24 2005 - 6:09PM
PR Newswire (US)
New Analysis Shows Cymbalta 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/ -- Cymbalta(TM) (duloxetine HCL)
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 Cymbalta, 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). Cymbalta 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 Cymbalta is promising," stated Joel Raskin, MD, FRCPC,
medical advisor Eli Lilly and Company. "Further research into the
benefit of Cymbalta in anxiety is needed." Additional Study
Highlights * When elderly patients were analyzed by age: - Patients
under 75 treated with Cymbalta 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 Cymbalta 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 Cymbalta. * In
this study, Cymbalta was safe and well tolerated, with
discontinuations due to adverse events occurring in less than 10
percent of those treated, with no difference between Cymbalta and
placebo. * The most common (>/= 5 percent) 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), 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 Cymbalta 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 Cymbalta
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,
Cymbalta is a balanced and potent reuptake inhibitor of serotonin
and norepinephrine. While the mechanism of action of Cymbalta 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.
Cymbalta is approved in the United States for the treatment of
major depressive disorder and the management of diabetic peripheral
neuropathic pain, both in adults. Cymbalta is not specifically
indicated for geriatric depression. As Cymbalta 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 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 symptoms 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 Cymbalta 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.
Nursing 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 is also 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
Patient Information, visit http://www.cymbalta.com/ . 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
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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