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| |  Patient's Mood Does Not Interfere With Milnacipran's Efficacy in Fibromyalgia: Presented at WCBP By Jill Stein PARIS -- July 1, 2009 -- Milnacipran is an effective treatment for the multiple symptoms of fibromyalgia syndrome independent of baseline mood, according to phase 3 data presented on July 1 at the 9th World Congress of Biological Psychiatry (WCBP). Jaime Branco, MD, Serviço de Reumatologia, Hospital Egas Moniz, Lisbon, Portugal, and colleagues determined the efficacy and safety of milnacipran compared with placebo in treating fibromyalgia syndrome in a European population. The study also aimed to assess whether its effects on fibromyalgia are based on its antidepressant activity. Overall, 449 patients were randomised to placebo and 435 to milnacipran 200 mg/day for 12 weeks of fixed-dose exposure. The planned primary analysis used a sequential testing procedure involving a composite response criterion, and then the change in Fibromyalgia Impact Questionnaire (FIQ) total score. Fibromyalgia composite responders were defined as patients concurrently reporting >=30% improvement from baseline in 24-hour recall pain and a rating of “very much improved” or “much improved” on the Patient Global Impression of Change scale. The data showed that significantly more patients on milnacipran satisfied criteria as fibromyalgia composite responders compared with patients receiving placebo (P = .0003; odds ratio, 1.9). Milnacipran-treated patients had significantly larger mean improvements on FIQ total score than placebo-treated patients (P = .015). Milnacipran treatment also produced statistically significant improvements on multiple domains at the 3-month endpoint versus placebo. Notably, differential response rates between placebo and drug were greater for patients with lower baseline Beck Depression Inventory scores. Overall improvements in patients’ condition and functioning were confirmed by significant improvements in weekly pain measured on daily electronic diaries, Brief Pain Inventory, Short Form-36 (Mental and Physical components), Multidimensional Fatigue Inventory total score, FIQ physical function subscale score, and Multiple Ability Self-Report Questionnaire cognition total score. The study also found that milnacipran’s effect was rapid (as soon as week 2 for pain) and was sustained throughout the treatment period. Milnacipran was well tolerated, and there were no unexpected tolerability or safety concerns. Dr. Branco said that the study’s findings confirm that the drug’s efficacy is independent of its antidepressant effect. Funding for this study was provided by Pierre Fabre. [Presentation title: The Beneficial Effect of Milnacipran on Fibromyalgia Is Not Related to Its Antidepressant Effects: A European, Multicenter, Controlled Trial. Abstract P-38-018]
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