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Efficacy and safety of milnacipran 100 mg/day in patients with fibromyalgia
Results of a randomized, double-blind, placebo-controlled trial.

Arnold LM, Gendreau RM, Palmer RH, Gendreau JF, Wang Y.
Arthritis Rheum. 2010 Sep;62(9):2745-56.

Abstract

OBJECTIVE: To assess the efficacy and safety of milnacipran at a dosage of 100 mg/day (50 mg twice daily) for monotherapy treatment of fibromyalgia.

Les auteurs concluent à une efficacité significativement plus importante dans le bras milnacipran versus placebo et ce sur les critères principaux comme l’ensemble des critères secondaires. Le pourcentage de patients avec amélioration >= 30% par rapport à l’inclusion a été de 30,6% dans le bras placebo versus 44,6% dans le bras milnacipran et la perception d’amélioration importante par le patient a été 41,9% dans le bras verum versus 25,9% dans le bras placebo.
Effet secondaire fréquent, les nausées 15,8% versus placebo
A suivre....

METHODS: A double-blind, placebo-controlled trial was performed to assess 1,025 patients with fibromyalgia who were randomized to receive milnacipran 100 mg/day (n = 516) or placebo (n = 509). Patients underwent 4-6 weeks of flexible dose escalation followed by 12 weeks of stable-dose treatment. Two composite responder definitions were used as primary end points to classify the response to treatment. The 2-measure composite response required achievement of >=30% improvement from baseline in the pain score and a rating of "very much improved" or "much improved" on the Patient's Global Impression of Change (PGIC) scale. The 3-measure composite response required satisfaction of these same 2 improvement criteria for pain and global status as well as improvement in physical function on the Short Form 36 (SF-36) physical component summary (PCS) score.

RESULTS: After 12 weeks of stable-dose treatment, a significantly greater proportion of milnacipran-treated patients compared with placebo-treated patients showed clinically meaningful improvements, as evidenced by the proportion of patients meeting the 2-measure composite responder criteria (P < 0.001 in the baseline observation carried forward [BOCF] analysis) and 3-measure composite responder criteria (P < 0.001 in the BOCF). Milnacipran-treated patients also demonstrated significantly greater improvements from baseline on multiple secondary outcomes, including 24-hour and weekly recall pain score, PGIC score, SF-36 PCS and mental component summary scores, average pain severity score on the Brief Pain Inventory, Fibromyalgia Impact Questionnaire total score (all P < 0.001 versus placebo), and Multidimensional Fatigue Inventory total score (P = 0.036 versus placebo). Milnacipran was well tolerated by most patients, with nausea being the most commonly reported adverse event (placebo-adjusted rate of 15.8%).

CONCLUSION: Milnacipran administered at a dosage of 100 mg/day improved pain, global status, fatigue, and physical and mental function in patients with fibromyalgia.
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