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Milnacipran/pregabalin effectively treated fibromyalgia patients
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Milnacipran added to pregabalin therapy improved symptoms among patients with fibromyalgia who had an incomplete response to pregabalin alone, according to study results.
In a multicenter, open-label study, researchers evaluated patients with fibromyalgia who were assigned pregabalin at 300 mg/day or 450 mg/day for a 4- to 12-week run-in period. Patients were classified as incomplete responders if they had a weekly recall visual analog scale (VAS) pain score of at least 40 and up to 90, Patient Global Impression of Severity score of at least 4 and Patient Global Impression of Change (PGIC) score of at least 3. Of those patients, 180 randomly were assigned pregabalin alone, while 184 were assigned 100 mg/day milnacipran in combination with pregabalin. Responder status based on PGIC score up to 2 was the primary efficacy outcome, while change after randomization in weekly recall VAS score was a secondary efficacy outcome.
PGIC response was significantly greater among patients assigned milnacipran and pregabalin (46.4%) compared with patients assigned only pregabalin (20.8%; P<.001).
Patients receiving milnacipran and pregabalin had a greater mean improvement from randomization in weekly recall VAS pain scores compared with patients receiving pregabalin alone (–20.77 vs. –6.43; P<.001). Dizziness (22.8%), somnolence (17.3%) and fatigue (9.1%) were the most common adverse events (AE) with pregabalin during run-in, while nausea (12.5%), fatigue (10.3%) and constipation (9.8%) were the most common AEs in patients treated with milnacipran and pregabalin.
“Adding milnacipran to pregabalin improved global status, pain and other symptoms in patients with fibromyalgia with an incomplete response to pregabalin treatment,” the researchers concluded.
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