A pooled analysis of two randomized, double-blind, placebo-controlled trials of milnacipran monotherapy in the treatment of fibromyalgia

Pain Practice : the Official Journal of World Institute of Pain
Michael E GeisserDaniel J Clauw

Abstract

Milnacipran has been shown to significantly improve the pain, global well-being, and physical function of fibromyalgia (FM), and is approved by the U.S. Food and Drug Administration for the management of this disorder. Post hoc analyses of data from two pivotal trials were conducted to further assess the clinical benefits of milnacipran, to determine the impact of baseline pain severity on treatment outcomes, and to confirm the safety and tolerability of this medication in patients with FM. Patients in these trials were randomized to placebo (n=624), milnacipran 100 mg/day (n=623), or milnacipran 200 mg/day (n=837). Two different composite responder analyses were used to evaluate efficacy: a 2-measure analysis, requiring ≥30% improvement from baseline visual analog scale 24-hour recall pain scores and a Patient Global Impression of Change (PGIC) score of "very much improved" or "much improved"; and a 3-measure analysis, requiring a ≥6-point improvement from baseline in SF-36 Physical Component Summary scores in addition to the pain and PGIC criteria. Additionally, a pooled analysis of mean changes from baseline pain scores was conducted in order to evaluate the efficacy of milnacipran over the entire course of treatment. At 3 m...Continue Reading

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Citations

Oct 31, 2012·International Journal of General Medicine·Lesley M ArnoldWei Chen
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Jul 10, 2013·The Annals of Pharmacotherapy·Amanda M HuskeyJames Aubrey Waddell
Mar 27, 2018·Pain·Michael E Geisser, Anna L Kratz

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