Cymbalta(R) Provided Sustained Pain Relief for Women with Fibromyalgia, Study Shows
October 18 2004 - 9:34AM
PR Newswire (US)
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 pager, , or Jennifer Yoder
(Outside U.S.), +1-317-433-3445 voice, , both of Eli Lilly and
Company
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