A three-year, open-label, flexible-dosing study of milnacipran for the treatment of fibromyalgia

Arnold, Lesley M.; Spera, Allan; Baldecchi, A.; Wang, Y.

doi:10.1016/j.jpain.2011.02.087

Cited by 2 publications

(5 citation statements)

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“…Based on World Health Organization criteria,26 77% of patients in these studies were classified as overweight or obese at baseline, with 49% of patients in the obese category (Figure 1). Similar demographics were found in patients who continued into extension studies22,23 and the open-label milnacipran study 24…”

Section: Resultssupporting

confidence: 56%

“…Similar demographics were found in patients who continued into extension studies 22 , 23 and the open-label milnacipran study. 24 …”

Section: Resultsmentioning

confidence: 99%

“…Analyses were also conducted in 354 patients who received milnacipran during lead-in and extension studies 22 , 23 and received ≥12 total months of continuous treatment, as well as 1227 patients in a 3-year, open-label, flexible-dosing study with milnacipran 24 who had participated in a prior placebo-controlled trial or extension study. To be as comprehensive as possible, additional analyses were conducted in 220 patients who received ≥3 years of treatment in the open-label study (ie, patients who reached the final study visit at 36–38 months).…”

Section: Methodsmentioning

confidence: 99%

“…The present set of analyses was conducted to investigate further the effects of milnacipran on weight in patients with fibromyalgia receiving short-term and long-term treatment. In addition to examining the effects of baseline BMI, treatment response, and nausea on body weight in a large sample of patients with fibromyalgia pooled from the three placebo-controlled trials of milnacipran,19–21 this report presents the following: pooled results from patients in double-blind extension studies who received ≥12 months of continuous milnacipran treatment22,23 and the findings from a long-term, open-label study that was conducted in patients who had participated in a previous milnacipran study 24. Analyses of data from a subset of patients who received ≥3 years of treatment in the open-label study were also conducted to evaluate the long-term effects of milnacipran on body weight.…”

Section: Introductionmentioning

confidence: 99%

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Effect of milnacipran on body weight in patients with fibromyalgia

Arnold¹,

Palmer²,

Hufford³

et al. 2012

IJGM

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BackgroundThe purpose of this study was to evaluate the effects of milnacipran on body weight in patients with fibromyalgia.MethodsAnalyses were conducted in the following groups: patients from three double-blind, placebo-controlled milnacipran trials (3 months, n = 2096; 6 months, n = 1008); 354 patients receiving milnacipran in placebo-controlled trials and double-blind extension studies (total ≥ 12 months of treatment); and 1227 patients in a long-term (up to 3.25 years) open-label milnacipran study.ResultsIn placebo-controlled trials, 77% of patients were overweight or obese at baseline (body mass index ≥ 25 kg/m2). Mean weight loss was found with milnacipran at 3 months (100 mg/day, −1.14 kg; 200 mg/day, −0.97 kg; placebo, −0.06 kg; P < 0.001) and 6 months (100 mg/day, −1.01 kg; 200 mg/day, −0.71 kg; placebo, −0.04 kg; P < 0.05). Approximately twice as many milnacipran-treated patients had ≥5% weight loss from baseline compared with placebo (3 and 6 months, P < 0.01). In extension studies, mean weight loss in patients receiving ≥12 months of milnacipran was −1.06 kg. In patients receiving ≥3 years of treatment in the open-label study, mean changes at 12, 24, 30, and 36–38 months were −1.16, −0.76, −0.19, and +0.11 kg, respectively. Among milnacipran-treated patients, rates of nausea (the most common adverse event) were lower among patients who lost weight than among those who did not (3 months, P = 0.02).ConclusionThe majority of patients with fibromyalgia in the milnacipran studies were overweight or obese. Milnacipran was associated with mean weight loss at 3 and 6 months (P < 0.05 versus placebo) and at 12 and 24 months of treatment, with mean changes drifting back to baseline at 30 months (−0.19 kg) and 36–38 months (+0.11 kg, no placebo comparison).

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Section: Resultssupporting

confidence: 56%

“…Similar demographics were found in patients who continued into extension studies 22 , 23 and the open-label milnacipran study. 24 …”

Section: Resultsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Effect of milnacipran on body weight in patients with fibromyalgia

Arnold¹,

Palmer²,

Hufford³

et al. 2012

IJGM

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“…Long-term durability of efficacy for reducing pain and other fibromyalgia symptoms and tolerability with milnacipran has been demonstrated in several studies [65][66][67][68]. These studies range from 6 months to 3 years in duration.…”

Section: Clinical Efficacymentioning

confidence: 97%

Milnacipran for fibromyalgia: a useful addition to the treatment armamentarium

Bernstein

Albrecht

Marcus

2013

Expert Opinion on Pharmacotherapy

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Milnacipran provides modest fibromyalgia pain relief and is best used as part of a multidisciplinary treatment approach. While milnacipran was not studied in fibromyalgia patients with major depression, it may be a wise choice for fibromyalgia patients with depressive symptoms and patients for whom sedation, dizziness, edema or weight gain with gabapentin and pregabalin is a problem. Milnacipran has been found to be beneficial for treating some troublesome fibromyalgia-associated symptoms, including fatigue and cognitive dysfunction.

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A three-year, open-label, flexible-dosing study of milnacipran for the treatment of fibromyalgia

Cited by 2 publications

References 0 publications

Effect of milnacipran on body weight in patients with fibromyalgia

Effect of milnacipran on body weight in patients with fibromyalgia

Milnacipran for fibromyalgia: a useful addition to the treatment armamentarium

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