Milnacipran combined with pregabalin in fibromyalgia: a randomized, open-label study evaluating the safety and efficacy of adding milnacipran in patients with incomplete response to pregabalin
作者： Philip J. Mease , Mildred V. Farmer , Robert H. Palmer , R. Michael Gendreau , Joel M. Trugman
关键词: Clinical trial 、 Milnacipran 、 Randomization 、 Fibromyalgia 、 Medicine 、 Visual analogue scale 、 Pregabalin 、 Adverse effect 、 Tolerability 、 Physical therapy
摘要: Objective:To evaluate the safety, tolerability, and efficacy of adding milnacipran to pregabalin in patients with fibromyalgia who have experienced an incomplete response pregabalin.Methods:In this randomized, multicenter, open-label study, received 300 or 450 mg/day during a 4- 12-week run-in period. Patients weekly recall visual analog scale (VAS) pain score at least 40 up 90, Patient Global Impression Severity 4, Change (PGIC) 3 were classified as responders randomized continue alone (n = 180) receive 100 added 184). The primary parameter was responder status based on PGIC 2. secondary change from randomization VAS score. Safety parameters included adverse events (AEs), vital signs, clinical laboratory tests.Results:The percentage responde...
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