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www.ProHealth.com • October 7, 2013


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

By Daniel J Clauw, et al.

Abstract:

INTRODUCTION: Previous studies of long-term treatment response in fibromyalgia and other chronic pain states have generally been limited to approximately a 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 time of randomized withdrawal was 36.1 months from initial exposure to milnacipran (range, 17.9 to 54.4 months).

METHODS:
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 4-week open-label period of the current study for evaluation of ongoing treatment response. After the 4-week period to confirm new baseline status, 151 patients taking milnacipran [greater than or equal to]100 mg/day and reporting [greater than or equal to]50% improvement from pre-milnacipran exposure in visual analog 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 switch to placebo. The prespecified primary parameter was loss of therapeutic response (LTR), defined as increase in VAS pain score to <30% reduction from pre-milnacipran exposure, or worsening of fibromyalgia requiring alternative treatment. Adverse events and vital signs were also monitored.

RESULTS:

  • Time to LTR was shorter in patients randomized to placebo than in patients continuing milnacipran (P<0.001).

  • Median time to LTR was 56 days with placebo and not calculable for milnacipran since less than half of these patients lost therapeutic response by study end.

  • Additionally, 81% of patients continuing on milnacipran maintained clinically meaningful pain response ([greater than or equal to]30% improvement from pre-milnacipran exposure), compared with 58% of patients switched to placebo (sensitivity analysis II; P<0.001).

  • Incidence of treatment-emergent adverse events was 58% and 47% for placebo and milnacipran, respectively.

  • Mean decreases in blood pressure and heart rate were found in both groups, with greater decreases for patients switched to placebo.

CONCLUSIONS: Continuing efficacy of milnacipran was demonstrated by the loss of effect following withdrawal of treatment in patients who received an average of 3 years of milnacipran treatment.

Source: Arthritis Research & Therapy, August 16, 2013. By Daniel J Clauw, Philip J Mease, Robert H Palmer, Joel M Trugman and Yong Wang.




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