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Fibromyalgia patients who stopped long-term milnacipran therapy exhibited greater response loss
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Patients with fibromyalgia who had received milnacipran therapy for an average of 3 years had a greater loss of therapeutic response when switched to placebo compared with those who continued treatment, according to recent study results.
Researchers studied patients with fibromyalgia who had received 50 mg/day to 200 mg/day milnacipran for up to 3.25 years in a long-term, open-label lead-in study. Prior treatment included a maximum of 15 months of milnacipran at 100 mg/day or 200 mg/day, resulting in up to 4.5 years of milnacipran exposure.
Three hundred forty patients completed a 4-week open-label period, in which they received the same milnacipran dosage as the lead-in study. One hundred fifty patients who received a minimum of 100/mg day milnacipran and achieved at least 50% improvement in visual analog scale (VAS) for pain were classified as responders. They were randomly assigned to continue milnacipran (n=100) or placebo (n=50) in a 12-week, double blind withdrawal period.
VAS pain score to less than 30% reduction from pre-milnacipran exposure or worsening of fibromyalgia that would require alternative therapy were defined as loss of therapeutic response (LTR). Placebo patients experienced a shorter time to LTR (median, 56 days) compared with patients who maintained treatment (primary analysis; HR=0.44; 95% CI, 0.27-0.71). Less than 50% of the patients on milnacipran lost response by the end of study, making LTR incalculable.
Among the patients who remained on milnacipran, 81% maintained clinically meaningful pain response, defined as better than 30% improvement from pre-milnacipran exposure, compared with 58% of patients switched to placebo (sensitivity analysis II; P<.001).
Fifty-eight percent of placebo-treated and 47% of milnacipran-treated patients experienced one or more treatment-emergent adverse events, none considered serious.
“In patients who had received milnacipran for an average of 3 years … loss of therapeutic response upon discontinuation of treatment provides evidence of long-term efficacy of this medication for the management of fibromyalgia,” the researchers concluded.
Disclosure: See the study for a full list of relevant financial disclosures.
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