Abstract
Objective. To evaluate the safety and efficacy of milnacipran, a dual norepinephrine and serotonin reuptake inhibitor, in the treatment of fibromyalgia (FM).
Methods. A 27-week, randomized, double-blind, multicenter study compared milnacipran 100 and 200 mg/day with placebo in the treatment of 888 patients with FM. Two composite responder definitions were used to classify each patient’s individual response to therapy. “FM responders” concurrently satisfied response criteria for improvements in pain (visual analog scale 24-h morning recall), patient global impression of change (PGIC), and physical functioning (SF-36 Physical Component Summary); while “FM pain responders” concurrently satisfied response criteria for improvements in pain and PGIC.
Results. At the primary endpoint, after 3-month stable dose treatment, a significantly higher percentage of milnacipran-treated patients met criteria as FM responders versus placebo (milnacipran 200 mg/day, p = 0.017; milnacipran 100 mg/day, p = 0.028). A significantly higher percentage of patients treated with milnacipran 200 mg/day also met criteria as FM pain responders versus placebo (p = 0.032). Significant pain reductions were observed after Week 1 with both milnacipran doses. At 15 weeks, milnacipran 200 mg/day led to significant improvements over placebo in pain (realtime, daily and weekly recall; all measures, p < 0.05), PGIC (p < 0.001), fatigue (p = 0.016), cognition (p = 0.025), and multiple SF-36 domains. Milnacipran was safe and well tolerated by the majority of patients during 27 weeks of treatment; nausea and headache were the most common adverse events.
Conclusion. Milnacipran is safe and effective for the treatment of multiple symptoms of FM.
Footnotes
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Supported by Forest Laboratories, Inc., New York, New York, and Cypress Bioscience, Inc., San Diego, California, USA. Dr. Mease has received research grant support from Pfizer Inc, Cypress Bioscience, Inc., Forest Laboratories, Inc., Eli Lilly and Company, Allergan, Wyeth Pharmaceuticals, Jazz Pharmaceuticals, and Fralex Therapeutics. Dr. Clauw has received grant support from Cypress Bioscience, Inc. and serves as a consultant to Cypress Bioscience, Inc, Forest Laboratories, Inc., Pierre Fabre Médicament, Pfizer Inc, Eli Lilly and Company, Wyeth Pharmaceuticals, and Proctor and Gamble. Dr. Mease was an investigator of this study and a consultant; Dr. Clauw was a consultant for this study. As consultants, Drs. Mease and Clauw were involved in the study design, analysis of results, and preparation of the manuscript. Drs. Gendreau, Rao, and Kranzler are employees of Cypress Bioscience, Inc. Drs. Chen and Palmer are employees of Forest Laboratories, Inc.
- Accepted for publication September 22, 2008.