New Data Show Cymbalta Improved Physical, Social and Emotional Functioning and Overall Health of Patients With Painful Diabetic
June 11 2005 - 1:00PM
PR Newswire (US)
New Data Show Cymbalta Improved Physical, Social and Emotional
Functioning and Overall Health of Patients With Painful Diabetic
Neuropathy SAN DIEGO, June 11 /PRNewswire-FirstCall/ -- Cymbalta(R)
(duloxetine hydrochloride) significantly improved physical, social
and emotional functioning, in addition to overall health, in
patients with pain associated with diabetic peripheral neuropathy
(DPNP), compared with those treated with a sugar pill, according to
a pooled analysis of three studies presented today at the annual
meeting of the American Diabetes Association. In the pooled
analysis of more than 1,000 DPNP patients, those treated with 60 or
120 mg of Cymbalta (given as 60 mg either once or twice daily),
reported significant improvements in all functional components
defined in three commonly used scales -- the interference portion
of the Brief Pain Inventory (BPI), the Short Form 36 (SF-36) and
the European Quality of Life Instrument 5D version (EQ-5D). That
means Cymbalta patients reported significantly less interference
from pain on key measures of physical functioning, including their
ability to walk, work and sleep. On a social level, patients taking
Cymbalta reported significantly less interference from pain on
their relationships with other people and their enjoyment of life.
Additionally, Cymbalta patients reported significantly less
interference from pain on mental health and mood. "The pain that
patients with diabetic neuropathy experience is severely limiting,
making everyday activities, like putting on socks or walking
around, extremely painful," said Dr. Amy Chappell, Eli Lilly and
Company. "In these studies, patients taking Cymbalta are feeling
relief from pain, but more importantly, they are actually able to
get their lives back and do the things they love." Nearly 5 million
Americans(i) experience the persistent tingling, burning or
stabbing pain caused by uncontrolled diabetes,(ii) which can have a
tremendous impact on a patient's quality of life. Painful diabetic
neuropathy can cause patients to feel isolated and worthless, as
the condition limits the ability to participate in life. Many DPNP
patients have trouble enjoying family activities, and may even need
to change jobs as a result of the pain.(iii) The U.S. Food and Drug
Administration (FDA) approved Cymbalta in September 2004 as the
first prescription drug proven to reduce DPNP in adults. It is the
only FDA-approved prescription treatment for DPNP available in the
United States. Cymbalta is also approved to treat major depressive
disorder in adults. Additional Study Highlights * Compared with
patients in the study who received placebo, or sugar pill, those
treated with 60 or 120 mg of Cymbalta per day reported significant
improvements in -- functioning, according to the average of the
seven questions on the interference portion of the BPI. -- bodily
pain, general health, mental health, physical function, role in
physical activity, emotional role, social function and vitality,
according to the SF-36. -- general health (mean change of 0.10,
compared with 0.15 and 0.16), according to the EQ-5D. -- pain,
including 24-Hour Average Pain Severity, 24-Hour Worst Pain Score,
Night Pain Score, McGill Pain Total Score, CGI-Severity, PGI
Improvement and BPI Severity. Methods The data were pooled from
three 12-week multicenter, double-blind studies. In one study
(N=457) patients diagnosed with DPNP were randomly assigned to
receive 20 mg of Cymbalta once daily, 60 mg of Cymbalta once daily,
60 mg of Cymbalta twice daily or a sugar pill. In the other two
studies (N=334, N=348) patients diagnosed with DPNP were randomly
assigned to receive 60 mg of Cymbalta once daily, 60 mg of Cymbalta
twice daily or a sugar pill. Functional outcomes were measured
based on patients' answers on the interference portion of the Brief
Pain Inventory, the Short Form 36 and the European Quality of Life
Instrument 5D version. The Interference Portion of the BPI is
commonly used in pain trials to measure the degree to which pain
interferes with daily life (i.e. general activity, walking,
working, sleep, mood, relationships and enjoyment of life). The
SF-36 consists of 36 items that evaluate eight health domains
related to quality of life: bodily pain, general health, mental
health, physical function, role-physical, role- emotional, social
function and vitality. The European Quality of Life Instrument 5D
measures mobility, usual activities, self care, pain and
discomfort, and anxiety and depression. Only those who completed
one of the three studies were included in the analyses. Patients
treated with Cymbalta 20 mg once daily were excluded from the
analyses. About Cymbalta Scientists believe Cymbalta reduces
diabetic peripheral neuropathic pain by blocking the re-absorption
of serotonin and norepinephrine, neurotransmitters involved in
regulating a person's sensitivity to pain. These chemical
messengers are part of the body's own internal pain-relief system
and, in the spinal cord, exert an analgesic effect in descending
pain pathways. Cymbalta is also indicated to treat major depressive
disorder in adults. Cymbalta has not been studied in children, and
therefore 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. Cymbalta is
available in 20 mg, 30 mg and 60 mg capsules. 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. About Diabetic Peripheral
Neuropathy According to the National Institute of Diabetes &
Digestive & Kidney Diseases, approximately half of those with
diabetes have some form of nerve damage, or neuropathy, but not all
will develop symptoms. While nerve problems can occur at any time,
the highest rates are among those who have had diabetes for at
least 25 years. People who have had problems controlling their
blood sugar levels, have high blood pressure, are overweight, have
high levels of blood fat, or are over the age of 40, may also have
a greater risk of developing diabetic peripheral neuropathy.
Symptoms can include numbness, tingling or pain and weakness in the
toes, feet, legs, hands, arms and fingers. These symptoms are often
worse at night.(iv) 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 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 the management of neuropathic pain
associated with diabetic peripheral neuropathy, the most common
side effects were nausea, sleepiness, dizziness, constipation, dry
mouth, increased sweating, decreased appetite, and loss of strength
or energy. In clinical studies of duloxetine for depression, the
most common side effects were nausea, dry mouth, constipation,
decreased appetite, fatigue, sleepiness, and increased sweating. 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 or for full Prescribing
Information, including Boxed Warning, visit
http://www.cymbalta.com/. P-LLY This press release contains
forward-looking statements about the potential of Cymbalta for the
treatment of diabetic peripheral neuropathic pain, 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) D Ziegler, FA Gries, M Spuler and F Lessman. The
epidemiology of diabetic neuropathy. J Diabetic complications.
(1992) 49-57. (ii) National Institute of Diabetes and Digestive and
Kidney Diseases. Diabetic Neuropathies: The Nerve Damage of
Diabetes. http://diabetes.niddk.nih.gov/dm/pubs/neuropathies/.
Accessed 5/16/05. (iii) Data on file. (iv) National Diabetes
Information Clearinghouse. Diabetic Neuropathies: The Nerve Damage
of Diabetes. National Institute of Diabetes and Digestive and
Kidney Diseases.
http://www.diabetes.niddk.nih.gov/dm/pubs/neuropathies/, August
2004. (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 media):
+1-317-651-3710 (office), +1-877-656-9084 (pager), or Jennifer
Yoder (OUS media): +1-317-433-3445 (office), +1-888-274-0289
(pager), both of Eli Lilly and Company
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