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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 )
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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