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Source: Doctor’s Guide
By Jerry Ingram

ORLANDO, FL -- March 5, 2004 -- Duloxetine, a drug being studied for treatment of depression, appears to be an effective and safe treatment for symptoms of fibromyalgia in patients with or without major depressive disorder (MDD), especially women, researchers said here on March 4th at the American Academy of Pain Medicine 20th Annual Meeting.

"We found that duloxetine has a direct effect on pain, which is not merely associated with treatment for depression," said Madelaine Wohlreich, MD, Clinical Research Physician, Eli Lilly and Company, Indianapolis, Indianapolis, United States. "Depression is very frequently accompanied by painful symptoms and by showing that we can affect painful symptoms with or without depression. It adds credibility to the fact that this drug might in fact offer something to depressed patients in particular."

For this trial, investigators enrolled 207 patients in a 12-week study, who received a single-blind placebo was administered in the first week and were then randomized to duloxetine 120 mg/daily or placebo. Primary outcome measures were assessed using the Fibromyalgia Impact Questionnaire (FIQ) total score and pain score.

Patients were also evaluated with the Clinical Global Impression of Severity, Patient Global Impression of Improvement, Brief Pain Inventory, Short Form (SF)-36, Quality of Life in Depression Scale and the Sheehan Disability Scale.

Researchers found that subjects treated with duloxetine improved more than placebo-treated patients on the FIQ total score, with a treatment difference of -5.53 (P = .027), but did not show significant improvement on the FIQ pain score. Subjects treated with duloxetine also had greater reduction in Brief Pain Inventory (BPI) average severity score (P = .008), BPI average interference from pain score (P = .004), tender point number (P = .022), and FIQ stiffness score (P = .048).

Duloxetine treatment also reported improvement Clinical Global Impression of Severity scores as well as superior results in quality of life according to Patient Global Impression of Improvement scores. The investigators noted that women in particular showed significantly greater improvement on virtually all efficacy measures compared with placebo-treated women. Men, however, did not show improvement on any efficacy measures.

Dr. Wohlreich and her associates concluded that duloxetine is an effective and safe treatment for many of the symptoms associated with fibromyalgia, particularly for women, who comprise the majority of this patients group.

[Study title: A Double-blind Trial Comparing Duloxetine to Placebo in the Treatment of Fibromyalgia with or without Major Depressive Disorder. Poster 166]

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