Continuing efficacy of milnacipran following long-term treatment in fibromyalgia: a randomized trial

Previous studies of long-term treatment response in fibromyalgia and other chronic pain states have generally been limited to approximately one year, leaving questions about the longer-term durability of response. The purpose of this study was to demonstrate continuing efficacy of milnacipran by cha...

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Published in:Arthritis research & therapy 2013-08, Vol.15 (4), p.R88-R88, Article R88
Main Authors: Clauw, Daniel J, Mease, Philip J, Palmer, Robert H, Trugman, Joel M, Wang, Yong
Format: Article
Language:English
Subjects:
Adrenergic Uptake Inhibitors - administration & dosage
Adrenergic Uptake Inhibitors - adverse effects
Analysis
Care and treatment
Chronic pain
Clinical trials
Complications and side effects
Cyclopropanes - administration & dosage
Cyclopropanes - adverse effects
Double-Blind Method
Female
Fibromyalgia
Fibromyalgia - drug therapy
Humans
Male
Medical research
Medicine, Experimental
Middle Aged
Pain Measurement
Patient outcomes
Pharmaceutical industry
Placebo effect
Time Factors
Treatment Outcome
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Summary:Previous studies of long-term treatment response in fibromyalgia and other chronic pain states have generally been limited to approximately one year, leaving questions about the longer-term durability of response. The purpose of this study was to demonstrate continuing efficacy of milnacipran by characterizing changes in pain and other fibromyalgia symptoms after discontinuing long-term treatment. The mean length of milnacipran treatment at the time of randomized withdrawal was 36.1 months from initial exposure to milnacipran (range, 17.9 to 54.4 months). After completing a long-term, open-label, lead-in study of milnacipran (which followed varying periods of exposure in previous studies), adult patients with fibromyalgia entered the four-week open-label period of the current study for evaluation of ongoing treatment response. After the four-week period to confirm new baseline status, 151 patients taking milnacipran ≥100 mg/day and reporting ≥50% improvement from pre-milnacipran exposure in Visual Analogue Scale (VAS) pain scores were classified as responders. These responders entered the 12-week, double-blind withdrawal period in which they were randomized 2:1 to continue milnacipran or switched to placebo. The prespecified primary parameter was loss of therapeutic response (LTR), defined as increase in VAS pain score to
ISSN:1478-6354
1478-6362
1478-6354
DOI:10.1186/ar4268