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Daily 100 mg Milnacipran Found Effective in Fibromyalgia

Drug improves pain, fatigue, and global scores; is well tolerated

THURSDAY, Sept. 23 (HealthDay News) -- Milnacipran at a dosage of 100 mg daily decreases pain and several other symptoms of fibromyalgia, according to research published in the September issue of Arthritis & Rheumatism.

Lesley M. Arnold, M.D., of the University of Cincinnati College of Medicine, and colleagues conducted a double-blind, placebo-controlled trial of 1,025 patients with fibromyalgia who were randomized to receive milnacipran 100 mg/day (50 mg twice daily) or placebo. The dose was gradually escalated upwards over a four to six week period. The purpose of the study was to assess the efficacy and safety of milnacipran at the 100 mg/day total dosage. Composite measures of treatment response were used as primary end points.

The researchers found that clinically meaningful improvements in the primary composite outcomes occurred in a significantly greater proportion of milnacipran-treated patients than placebo patients. Patients in the milnacipran group also had significantly greater improvements in several secondary outcomes, including 24-hour and weekly recall pain scores as well as mental component, pain severity, and fatigue scores. Nausea was the most common side effect, though the drug was well tolerated by most patients.

"The results of this trial are consistent with those of two previous pivotal studies of milnacipran using the same composite response criteria. Use of the composite responder definition in these studies allows for an assessment of clinically meaningful improvements across multiple symptom and function domains in individual patients," the authors write.

The authors disclosed financial relationships with the pharmaceutical industry, including Forest Laboratories and Cypress Bioscience, manufacturers of milnacipran. Forest Laboratories sponsored the study.

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