Rheumatology Medical News about fibromyalgia;Milnacipran

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The efficacy and safety of milnacipran for treatment of fibromyalgia. A randomized, double-blind, placebo-controlled trial
Journal of Rheumatology, 03/18/09

Mease PJ et al – Milnacipran (a dual norepinephrine and serotonin reuptake inhibitor) is safe and effective for the treatment of multiple symptoms of fibromyalgia (FM).

Methods

Study to evaluate the safety and efficacy of milnacipran in the treatment of FM
A 27-wk, study compared milnacipran 100 and 200 mg/d with placebo in 888 pts
2 composite responder definitions used to classify each pt’s individual response to therapy:
“FM responders” concurrently satisfied response criteria for improvements in pain, PGIC, and physical functioning
“FM pain responders” concurrently satisfied response criteria for improvements in pain and PGIC

Results

At the primary endpoint, a higher percentage of milnacipran-treated pts met criteria as FM responders
A higher percentage of pts treated with milnacipran 200 mg/d also met criteria as FM pain responders
Significant pain reductions observed after Wk 1 with both milnacipran doses
At 15 wks, milnacipran 200 mg/d led to improvements in pain, PGIC, fatigue, cognition, and multiple SF-36 domains
Milnacipran was safe and well tolerated by majority of pts during 27 wks of treatment
Nausea and headache were the most common AEs

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