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Duloxetine Appears Effective in Treating Patients With Fibromyalgia Syndrome: Presented at AAPM

By Ric Susman

KISSIMMEE, FL -- February 18, 2008 -- Patients with fibromyalgia syndrome appear to obtain better pain control with the selective serotonin and norepinephrine reuptake inhibitor duloxetine.

Researchers led by Madelaine Wohlreich, MD, Medical Advisor, Eli Lilly and Company, Indianapolis, Indiana, United States, attempted to determine whether treatment with duloxetine 120 mg daily for 3 months could reduce pain severity in patients with fibromyalgia syndrome.

"Duloxetine 60 mg daily and 120 mg daily were superior to placebo during the 3-month treatment period on the coprimary measures, both in brief pain inventory average pain score and the patient's global impressions of improvement," Dr. Wohlreich said in her poster presentation February 14 here at the American Academy of Pain Medicine (AAPM) 24th Annual Meeting.

At 3 months, patients treated with duloxetine 120 mg daily showed greater improvement in change from baseline in the Brief Pain Inventory Average Pain Score (APS; -2.31 vs -1.38, P < .001) and at endpoint in the Patients Global Impressions of Improvement score (PGII; 2.89 vs 3.39, P = .004) versus placebo-treated patients.

At 6 months, the duloxetine 120-mg-daily group still exhibited greater improvement in APS change (-2.25 vs -1.42, P = .003) and PGII (2.93 vs 3.37, P = .012), Dr. Wohlreich said.

The researchers enrolled 520 patients and randomised them into 4 different subgroups: 79 patients received duloxetine 20 mg daily, 150 patients received duloxetine 60 mg daily, 147 patients received 120 mg daily, and 144 patients received placebo. At least 80% of the patients in each arm of the study were Caucasian and at least 90% of each arm were women.

"There was no significant difference between duloxetine and placebo in the overall rate of discontinuations, but discontinuation due to an adverse event was significantly more frequent for duloxetine 120 mg daily than placebo," Dr. Wohlreich said. The discontinuation rate between placebo and the other dosages was not significant.

Changes in laboratory tests over the 6 months of the trial were similar among the groups. "Differences in mean change from baseline to endpoint between the duloxetine and placebo groups were small and not considered clinically relevant," she said.

Funding for this trial was provided by Eli Lilly and Company and Boehringer Ingelheim Pharmaceuticals, Inc.


[Presentation title: The Safety and Efficacy of Duloxetine Hydrochloride for the Treatment of Fibromyalgia: Results for a 6-Month Randomized, Double-Blind, Placebo-Controlled, Fixed Dosage. Abstract 159]

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