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Cymbalta(R) Provided Sustained Pain Relief for Women with
Fibromyalgia, Study Shows
Improvement in pain unrelated to effect on mood and presence of major
depression
SAN ANTONIO, Oct. 18 /PRNewswire-FirstCall/ -- The antidepressant Cymbalta(R)
(duloxetine HCl; pronounced sim-BAWL'-tuh), a dual-reuptake inhibitor of
serotonin and norepinephrine, 60 mg once or twice daily, significantly reduced
pain in more than half of women treated for fibromyalgia, with and without
major depression, according to 12-week data presented this week at the annual
meeting of the American College of Rheumatology.
These data are being presented one month after another study, in which Cymbalta
also significantly reduced pain in women with fibromyalgia versus placebo, was
published in Arthritis and Rheumatism.
"The results in these study patients were very striking in the degree of
reduction of pain, which is the primary symptom of fibromyalgia. In addition,
Cymbalta significantly improved these patients' quality of life and overall
functioning, as measured by quality of life and disability scales," said Lesley
M. Arnold, MD, University of Cincinnati College of Medicine, Cincinnati, Ohio,
who presented the study. "For many, the pain of fibromyalgia makes them so
sensitive to being touched that even a hug from a loved-one can be
intolerable."
In the study, Cymbalta's effect on pain was independent of any effect on mood,
and there was no significant difference in response rates between patients in
the study with and without major depression.
Fibromyalgia is a chronic disorder that causes widespread pain and tenderness
in the muscles and soft tissue of nearly 6 million Americans, predominantly
women.(1) According to the National Fibromyalgia Association, patients often
experience a deep muscular aching, throbbing, twitching, stabbing and shooting
pain that "knows no boundaries, migrating to all parts of the body and varying
in intensity." Neurological complaints, such as numbness, tingling and burning,
are often present and add to the discomfort of the patient.
While the cause of fibromyalgia remains unknown, it has been linked to
abnormalities in the brain's neurotransmitters, serotonin and norepinephrine,
the same neurotransmitters believed to play a role in major depressive
disorder, diabetic peripheral neuropathic pain and stress urinary
incontinence.(1)
There is no approved treatment for fibromyalgia. Cymbalta, a balanced and
potent serotonin and norepinephrine reuptake inhibitor, is proven to help treat
the emotional and painful physical symptoms of depression. It also is the only
approved treatment for management of pain caused by diabetic peripheral
neuropathy, a type of nerve damage. Cymbalta is not approved for the treatment
of fibromyalgia.
Study Findings
* More than half of patients treated with 60 mg of Cymbalta, once or twice
daily, responded to treatment after 12 weeks, compared with one-third of those
taking a sugar pill.
* Patients treated with 60 mg of Cymbalta, once or twice daily, were
significantly more likely to experience a sustained treatment response than
those treated with a sugar pill (44 percent, 43 percent and 19 percent,
respectively).
* Patients treated with 60 mg of Cymbalta, once or twice daily, had functional
improvements on the Sheehan Disability Scale which measures disability at work,
in family life and in social life, that were significantly greater than those
of patients taking a sugar pill.
* Cymbalta 60 mg once or twice daily directly reduced pain (75.7 and 87.5
percent, respectively) more than the indirect effect attributed to improvement
in depressive symptoms (24.4 percent and 12.5 percent, respectively).
* Cymbalta 60 mg twice a day also relieved the pain associated with tender
points often associated with fibromyalgia.
* Treatment-emergent adverse events were more common in patients treated with
Cymbalta 60 mg once or twice daily, than in those treated with a sugar pill
(79.2 percent). Events were typically mild to moderate in severity.
* Patients taking Cymbalta 60 mg once or twice daily were more likely to
discontinue because of side effects than those taking placebo (21.2 percent,
23.3 percent and 11.7 percent respectively).
* The most common side effects for patients taking Cymbalta (occurring in at
least 5 percent of patients and at twice the rate for those receiving placebo)
were nausea, dry mouth, constipation, diarrhea, decreased appetite,
nasopharyngitis, increased sweating and anorexia. In addition, for patients
taking Cymbalta 60 mg twice daily, sleepiness and feeling jittery were common
side effects.
Methodology
In a 12-week, double blind study, patients were randomized to receive Cymbalta
60 mg once (n=118) or twice daily (n=116), or placebo (n=120). The primary
outcome measure was Brief Pain Inventory (BPI) 24-hour average pain severity
score (score range: 0 [no pain] -10 [pain as bad as you can imagine]).
Response to treatment was defined as a 30 percent reduction in the BPI 24-hour
average pain score. Secondary outcome measures included remaining BPI pain and
interference scores, Fibromyalgia Impact Questionnaire (FIQ), the tender point
pain threshold and tender point number, Clinical Global Impression of Severity
(CGI-Severity), Patient Global Impression of Improvement (PGI-Improvement), and
the 17-item Hamilton Rating Scale for Depression.
About Cymbalta
Cymbalta is indicated for the treatment of major depression and the management
of diabetic peripheral neuropathic pain, both in adults. As Cymbalta 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
Patients being treated with antidepressants should be observed closely for
clinical worsening of depressive symptoms and suicidality. Patients and their
families should watch for these as well as for anxiety, agitation, panic,
difficulty sleeping, irritability, hostility, aggressiveness, impulsivity,
restlessness, or overexcitement and hyperactivity. Call the doctor if any of
these are severe or occur suddenly. Be especially observant when starting any
antidepressant therapy and 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 serious 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 the fibromyalgia study of Cymbalta, the most common side effects were
nausea, dry mouth, constipation, decreased appetite and anorexia. 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 muscle weakness. 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/ .
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/ .
This press release contains forward-looking statements about the potential of
Cymbalta for the treatment of fibromyalgia and reflects Lilly's current
beliefs. However, as with any pharmaceutical product under development, there
are substantial risks and uncertainties in the process of development and
regulatory review. There is no guarantee that the company will apply for or
receive regulatory approval for this indication. There is also no guarantee
that the product with 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.
(1) American College of Rheumatology. Fibromyalgia Fact Sheet. Available at:
http://www.rheumatology.org/public/factsheets/fibromya.asp . Accessed October
4, 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 (U.S.), +1-317-651-3710 voice, +1-877-656-9084
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