Patients Taking Cymbalta Also Reported Reduced Painful Physical
Symptoms and Improved Functioning MIAMI, March 24
/PRNewswire-FirstCall/ -- A new study of approximately 500 patients
evaluated the safety and efficacy of the antidepressant Cymbalta(R)
(duloxetine HCl) on the core anxiety symptoms in patients with
generalized anxiety disorder. Cymbalta significantly reduced core
anxiety symptoms and associated painful physical symptoms and
improved functional impairment associated with the illness. Results
will be announced on Saturday, March 25, in two separate
presentations(i,ii) at the Anxiety Disorders Association of America
(ADAA) Annual Conference. In this nine-week study, Cymbalta
significantly improved core anxiety symptoms such as anxious mood,
fears and tension by 51 percent in patients taking 60mg/day and by
50 percent in patients taking 120mg/day compared to an improvement
of 32 percent in patients taking sugar pill. Patients taking both
60mg/day and 120mg/day had significantly greater response and
remission rates compared to patients taking sugar pill. In
addition, Cymbalta significantly reduced overall pain by 41 percent
and 37 percent respectively, compared to 16 percent in patients
taking sugar pill. Cymbalta patients also reported greater
improvement in quality of life as measured by the Sheehan
Disability Scale, Quality of Life Enjoyment and Satisfaction
Questionnaire and European Quality of Life 5 Dimensions, including
improved ability to perform everyday activities at work, home, and
in social situations compared to sugar pill. "While it is important
to evaluate anxiety symptoms such as excessive worry and
irritability, it is also important to evaluate associated painful
physical symptoms and functioning because many patients also report
these symptoms," said Christer Allgulander, MD, associate
professor, senior lecturer, Karolinska Institutet, and lead author
on the study. "These data suggest that not only was Cymbalta able
to significantly improve the core anxiety symptoms, but it also
reduced painful physical symptoms associated with the disorder and
improved functioning resulting in improved quality of life." "We
are encouraged by these results that suggest Cymbalta may address a
broad range of core anxiety symptoms and the associated physical
symptoms that are often reported in patients with generalized
anxiety disorder," said James Russell, MD, medical advisor, Eli
Lilly and Company. Study Highlights * Compared to sugar pill,
patients receiving Cymbalta 60mg/day and 120mg/day experienced
significant improvement in symptom severity and disability
associated with generalized anxiety disorder, including: --
Significantly greater improvement in the severity of anxiety
symptoms, such as anxious mood, fears and tension, as measured by
the Hamilton Anxiety Scale. (average improvement 60mg = 51%, 120mg
= 50%, sugar pill = 32%) -- Greater response rates (58%, 56%, 31%,
respectively) -- Greater sustained improvement rates (64%, 67%,
43%, respectively) * Patients receiving Cymbalta 60mg/day and
120mg/day experienced greater remission rates compared to those
receiving sugar pill (31%, 38% and 19%, respectively). * Compared
to sugar pill, patients receiving Cymbalta 60mg/day and 120mg/day
reported significant improvement in ratings on the Visual Analogue
Scale for Pain for each of the following pain items: -- Overall
pain (average improvement 60mg = 41%, 120mg = 37%, sugar pill =
16%) -- Headaches (34%, 38%, 13%, respectively) -- Back pain (44%,
46%, 14%, respectively) -- Shoulder pain (47%, 43%, 19%,
respectively) -- Interference due to pain (39%, 41%, 10%,
respectively) -- Pain during waking hours (42%, 43%, 12%,
respectively) * In this study, the most common adverse events
(occurred at a rate of greater than or equal to 5 percent and at
least twice the rate of placebo) were nausea, dizziness, dry mouth,
fatigue, hyperhidrosis, insomnia, constipation, diarrhea, decreased
libido, anorexia, somnolence, vomiting and sedation. Methods In
this study of patients with generalized anxiety disorder, 168
patients were randomly assigned to receive 60mg of Cymbalta a day,
170 patients received 120mg of Cymbalta a day and 175 patients
received a sugar pill. Patients with a recent diagnosis (within six
months) of major depression were excluded from this study. The
primary endpoint of the study was effect on anxiety symptoms as
measured by the Hamilton Anxiety Scale (HAMA). Changes from
baseline to endpoint were analyzed using ANCOVA. Secondary measures
included effects on associated pain and functioning. Pain was
assessed using a Visual Analogue Scale. Functional outcomes, such
as the ability to complete everyday activities at work, home, and
in social situations, were measured using the Sheehan Disability
Scale (SDS), the Quality of Life Enjoyment and Satisfaction
Questionnaire short form (Q-LES-Q-SF) and the European Quality of
Life 5 Dimensions (EQ-5D). About Generalized Anxiety Disorder
Approximately four million Americans are diagnosed with generalized
anxiety disorder each year.(iii) Symptoms persist for at least six
months and can include exaggerated worry or chronic anxiety and
irritability, which can lead to poor concentration, and
procrastination, as well as physical symptoms like muscle tension,
fatigue and nausea.(iv) Episodes of generalized anxiety disorder
may be brought on, or worsened by, stressful life events. The
illness also tends to be chronic with periods of exacerbation and
remission.(v) About Cymbalta Serotonin and norepinephrine in the
brain and spinal cord are believed to both mediate core depression
symptoms and help regulate the perception of pain. It is common for
anxiety disorders to be associated with other disorders, such as
depression.(vi) 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 due to 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 approved for use
in pediatric patients. 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 for worsening depression symptoms,
suicidal thoughts or 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 antidepressive 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 Mellaril(R) (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. Tell
your doctor if you are taking other prescription or nonprescription
medications. In clinical studies of Cymbalta for depression, the
most common side effects were nausea, dry mouth, constipation,
decreased appetite, fatigue, sleepiness, and increased sweating.
Nausea was the most common side effect. For most people, the nausea
was mild to moderate, and usually subsided within one-to-two weeks.
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 Eli
Lilly and Company 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 generalized anxiety 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 continue 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)
Duloxetine as an Effective Treatment for Improving Painful Physical
Symptoms and Functioning Associated with Generalized Anxiety
Disorder; C Allgulander, H Koponen, J Erickson, Y Pritchett, M
Detke, S Ball, J Russell (ii) A Fixed Dose Study of the Efficacy
and Safety of Duloxetine for the Treatment of Generalized Anxiety
Disorder; H Koponen, C Allgulander, Y Pritchett, J Erickson, M
Detke, S Ball, J Russell (iii) National Institute of Mental Health.
"Facts About Generalized Anxiety Disorder." Available at:
http://www.nimh.nih.gov/publicat/gadfacts.cfm. Accessed on:
February 6, 2006 (iv) National Mental Health Association. "Anxiety
Disorders." Available at:
http://www.nmha.org/pbedu/anxiety/anxdis.cfm. Accessed on: February
7, 2006 (v) APA. "Diagnostic and Statistical Manual of Mental
Disorders - Fourth Edition." 1994, pp 472-476. (vi) Anxiety
Disorders Association of America "Medications for Anxiety
Disorders" Available at:
http://www.adaa.org/GettingHelp/AnxietyDisorders/chart.htm.
Accessed on March 13, 2006. (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: Tamara Hull (US), +1-317-651-9116,
or David Shaffer (OUS), +1-317-651-3710, both of Eli Lilly and
Company
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