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Milnacipran Shows Good Results in Fibromyalgia Patients: Presented at EULAR By Genie Benoist PARIS -- June 12, 2008 -- Milnacipran is a safe and effective treatment for fibromyalgia, according to a randomised study presented here at the European Union League Against Rheumatism (EULAR) Congress 2008. Milnacipran is a dual norepinephrine (NE) and serotonin (5-HT) reuptake inhibitor with preference for NE reuptake inhibition over 5-HT. Philip Mease, MD, Seattle Rheumatology Associates, Seattle, Washington, and colleagues evaluated the safety and efficacy of milnacipran in 888 patients diagnosed with fibromyalgia according to 1990 criteria from the American College of Rheumatology. In the study, presented on June 12, patients received 6 months of treatment with placebo, milnacipran 100 mg/day, or milnacipran 200 mg/day. Primary endpoints were predefined at 3 and 6 months. Fibromyalgia syndrome composite responders were defined as individuals having 30% or better improvement in pain from baseline according to the patient experience diary, a rating of "very much improved" or "much improved" on the Patient Global Impression of Change (PGIC) scale, and an improvement of 6 or more points in physical function according to the Short Form-36 Physical Component Summary score. Fibromyalgia pain composite responders were defined as patients satisfying the above criteria for improvement in pain and patient global impression of change. Milnacipran treatment resulted in significant improvements compared with placebo in fibromyalgia syndrome composite responder rates at 3 months at 100 mg/day (P = .028) and 200 mg/day (P = .017). Fibromyalgia pain composite responder rates for patients treated with milnacipran 200 mg/day were also significantly improved compared with placebo at 3 months (P = .032) and 6 months (P = .034). Patients on milnacipran had better PGIC scores than placebo patients at 3 months (100 mg/day, P = .001; 200 mg/day, P < .001) and at 6 months (100 mg/day, P = .014; 200 mg/day, P < .001). Both doses of milnacipran resulted in significant improvement over placebo in PGIC time-weighted averages at 3 months and 6 months (both doses and intervals, P < .01). Improvements in pain were apparent after 1 week of treatment. Adverse events reported most commonly were nausea, headache, and constipation. In each treatment group, about 90% of adverse events were mild or moderately severe. Adverse events caused 19.6%, 27.2%, and 10.9% of patients to withdraw from treatment prematurely in the milnacipran 100 mg/day, milnacipran 200 mg/day, and placebo groups, respectively. Fibromyalgia is a chronic disorder characterised by widespread musculoskeletal pain and a reduced threshold for pain. It comprises a constellation of symptoms including sleep disturbance, morning stiffness, and cognitive impairment. Funding for the study was provided by Forest Laboratories, Inc., and Cypress Bioscience, Inc. [Presentation title: Milnacipran Efficacy and Safety in the Treatment of Fibromyalgia. Abstract THU 0379] E-mail this page to a friend or colleague! To print, use this version