Milnacipran Improves Core Symptoms of Fibromyalgia Syndrome: Presented at ECNP

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Title: Milnacipran Improves Core Symptoms of Fibromyalgia Syndrome: Presented at ECNP
URL: http://www.pslgroup.com/dg/22A77A.htm
Doctor's Guide
September 2, 2008

By Judith Moser, MD

BARCELONA, Spain -- September 2, 2008 -- A 12-week course of milnacipran 200 mg QD appears to be a safe and effective treatment option for patients with fibromyalgia syndrome, researchers reported here at the 21st European College of Neuropsychopharmacology Congress (ECNP).

Double-blind, placebo-controlled studies have provided evidence for the efficacy of the norepinephrine and serotonin reuptake inhibitor milnacipran in the treatment of fibromyalgia syndrome.(1,2)

The aim of the current European multicentre, randomised, double-blind, placebo-controlled trial was to demonstrate the efficacy of milnacipran in improving the core symptoms of fibromyalgia.

A total of 884 patients with a diagnosis of a fibromyalgia syndrome according to the 1990 American College of Rheumatology criteria were enrolled in 83 centres across Europe, explained study presenter Yves Mainguy, MD, PhD, Pierre Fabré Médicament, Boulogne, France. Out of these, 876 patients were included in the primary efficacy analysis.

In the course of the 19-week study, 446 patients received placebo and 430 patients were treated with a fixed dose of milnacipran 100 mg BID after a 4-week dose escalation. The full-dose treatment period was followed by a 9-day down-titration and a 2-week post-treatment follow-up.

The primary efficacy endpoint was the composite responder rate for pain (reduction from baseline of 30% or greater in the 24-hour Recall Pain Visual Analog Scale) and a Patient Global Impression of Change rating of 1 (very much improved) or 2 (much improved).

Milnacipran showed a significant improvement relative to placebo, with higher response rates in the primary composite endpoint (24.2% vs 14.6%; P = .0003). Also, the Fibromyalgia Impact Questionnaire total score was in favour of milnacipran (P = .015).

Milnacipran induced significant improvements compared with placebo on multiple symptom domains such as pain, global status of the patient, quality of life (physical and mental components), fatigue, and cognition.

For all parameters, the efficacy of the milnacipran versus placebo was observed at the first on-treatment assessment visit in week 4, and was maintained up to the end of treatment.

Sleep was described as more refreshing as of the first week of treatment, and patients reported pain reductions as soon as week 2 and reductions in fatigue by week 3.

Most treatment-related adverse effects were of mild or moderate intensity and occurred during the dose-escalation period.

"This study was a clear demonstration of the efficacy of milnacipran in patients with fibromyalgia syndrome," Dr. Mainguy summarised.

Funding for this study was provided by Laboratoires Pierre Fabre.

1. Gendreau RM et al. J Rheumatol. 2005;32:1975-1985.

2. Mease P et al. Ann Rheum Dis. 2008;67(suppl 2):256.

[Presentation title: Milnacipran for the Treatment of Fibromyalgia Syndrome: A European Multicentre, Randomised, Double-Blind, Placebo-Controlled Trial. Abstract P8a014]

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