News - Duloxetine Reduces Fibromyalgia Pain: Presented at AAPM

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Duloxetine Reduces Fibromyalgia Pain: Presented at AAPM

By Crystal Phend

SAN DIEGO, CA -- February 27, 2006 -- The antidepressant duloxetine

(Cymbalta) appears effective in treating pain and improving quality

of life compared to placebo in women with fibromyalgia, researchers

said here February 23rd at the 22nd Annual Meeting of the American

Academy of Pain Management (AAPM).

" There are no approved drugs for fibromyalgia, " said presenting

author J. Detke, MD, PhD, medical director for Cymbalta at

Lilly Research Laboratories, Indianapolis, Indiana. " It's a

significant medical problem. "

Although the same serotonin and norepinephrine systems responsible

for depression are dysfunctional in patients with fibromyalgia, Dr.

Detke said duloxetine's pain-relieving effect appears independent

from its effect on mood.

The researchers presented two randomized, placebo-controlled, double-

blind studies of women with fibromyalgia according to the American

College of Rheumatology criteria and significant pain (an intensity

of at least 4 on the Fibromyalgia Impact Questionnaire or Brief Pain

Inventory). Twenty-five to 40% of the patients had a current major

depressive disorder and all baseline characteristics were similar

between treatment arms.

In the first study, 92 women received 60 mg of duloxetine twice daily

while another 92 received placebo. In the second study, 118 were

randomized to 60 mg of duloxetine once daily, 116 to a dose of 60 mg

twice daily, and another 120 to placebo.

Average pain scores were significantly lower by about 1 point in both

studies for the duloxetine groups compared with placebo, but there

was no difference between once and twice daily dosing groups in the

second study. Both studies showed significantly greater percentages

of patients achieving a 50% reduction in pain on duloxetine versus

placebo, which Dr. Detke called a " pretty robust " finding.

Fatigue and rest scores showed similar significant reductions in the

second study for duloxetine versus placebo. The reductions were not

significant in the first study.

Patients with and without major depressive disorder experienced the

same significant reduction in pain compared to placebo. No

significant interaction between pain alleviation and depression was

found in either study.

The authors concluded that duloxetine was safe and effective in

treating fibromyalgia pain.