Efficacy of milnacipran in patients with fibromyalgia

• Published in: Journal of rheumatology 2005-10, Vol.32 (10), p.1975-1985
• Main Authors: GENDREAU, R. Michael, THORN, Michael D, GENDREAU, Judy F, KRANZLER, Jay D, RIBEIRO, Saulo, GRACELY, Richard H, WILLIAMS, David A, MEASE, Philip J, MCLEAN, Samuel A, CLAUW, Daniel J
• Format: Article
• Language: English
• Subjects: Analgesics - therapeutic use; Antidepressive Agents, Tricyclic - therapeutic use; Biological and medical sciences; Cyclopropanes - therapeutic use; Diseases of the osteoarticular system; Dose-Response Relationship, Drug; Double-Blind Method; Female; Fibromyalgia - drug therapy; Fibromyalgia - pathology; Fibromyalgia - physiopathology; Humans; Male; Medical sciences; Middle Aged; Miscellaneous. Osteoarticular involvement in other diseases; Pain - physiopathology; Pain - prevention & control; Pain Measurement; Serotonin Uptake Inhibitors - therapeutic use; Sickness Impact Profile; Treatment Outcome
• ISSN: 0315-162X; 1499-2752

OBJECTIVE: Fibromyalgia (FM) is a common musculoskeletal condition characterized by widespread pain, tenderness, and a variety of other somatic symptoms. Current treatments are modestly effective. Arguably, the best studied and most effective compounds are tricyclic antidepressants (TCA). Milnacipran, a nontricyclic compound that inhibits the reuptake of both serotonin and norepinephrine, may provide many of the beneficial effects of TCA with a superior side effect profile. METHODS: One hundred twenty-five patients with FM were randomly assigned in a 3:3:2 ratio to receive milnacipran twice daily, milnacipran once daily, or placebo for 3 months in a double-blind dose-escalation trial; 92% of twice-daily and 81% of once-daily participants achieved dose escalation to the target milnacipran dose of 200 mg. RESULTS: The primary endpoint was reduction of pain. Both the once- and twice-daily groups showed statistically significant improvements in pain, as well as improvements in global well being, fatigue, and other domains. Response rates for patients receiving milnacipran were equal in patients with and without comorbid depression, but placebo response rates were considerably higher in depressed patients, leading to significantly greater overall efficacy in the nondepressed group. CONCLUSION: In this Phase II study, milnacipran led to statistically significant improvements in pain and other symptoms of FM. The effect sizes were equal to those previously found with TCA, and the drug was generally well tolerated.