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Longterm therapeutic response to milnacipran treatment for fibromyalgia. A European 1-year extension study following a 3-month study
The Journal of Rheumatology, 04/05/2011
Clinical Article
Branco JC et al. – Over 1 year, milnacipran 100, 150, and 200 mg/day exhibited sustained and safe therapeutic effects on predominant symptoms of FM.
Methods- 468 patients with FM successfully completing lead-in study were either blindly maintained on milnacipran 200 mg/day (MLN200:MLN200, n = 198) or (if previously receiving placebo) rerandomized to milnacipran 100 mg/day (PBO:MLN100, n = 91), 150 mg/day (PBO:MLN150, n = 92), or 200 mg/day (PBO:MLN200, n = 87) for an additional 12 months (including a 4-week dose escalation)
- Main efficacy endpoint 2-measure composite responder rate (relative to lead-in study baseline) incorporating weekly-recall pain score recorded on visual analog scale and Patient Global Impression of Change score
- Panel of other assessments including Fibromyalgia Impact Questionnaire explored multidimensional aspects of FM
- Descriptive analyses using last observation carried forward approach performed
- At 1-year endpoint, proportion of composite responders (relative to lead-in study baseline) ranged from 27.5% (PBO:MLN100) to 35.9% (MLN200:MLN200), and had increased from extension study baseline by 15.2% (PBO:MLN150) to 20.7% (PBO:MLN200 and MLN200:MLN200)
- At endpoint, improvement from both baselines shown in all groups on pain, fatigue, sleep, and quality of life measures
- Up to 1 year, all doses of milnacipran safe and well tolerated
- Most common drug-related adverse events hyperhidrosis and nausea
