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• W2079286087 abstract "Background Peripheral diabetic neuropathy affects between 20% and 45% of patients with diabetes. Objective To ascertain the effect of lacosamide on pain associated with peripheral diabetic neuropathy. Methods One hundred nineteen patients with a 1 to 5-year history of pain attributed to diabetic neuropathy and a score of ≥4 on the Likert pain scale entered the multicenter, randomized, double-blind, placebo-controlled trial. Lacosamide (N=60) titrated from 100 to 400 mg/d or maximum tolerated dose and placebo (N=59) were the trial interventions. Primary efficacy criterion was change in pain score on the 11-point Likert pain scale. Secondary assessments included Short-Form McGill Pain and Short-Form-36 Quality of Life Questionnaires, sleep/activity interference, pain intensity, Patient and Clinical Global Impression of Change, and Profile of Mood. Patients receiving at least 1 dose of medication underwent safety evaluation. Results Ninety-four patients (lacosamide 46; placebo 48) completed the trial. Lacosamide had significantly (P=0.039) better pain relief versus placebo (primary outcome). Improvements were also seen in secondary outcome measures. Adverse events occurred in 52 lacosamide and 44 placebo patients. Common adverse events, occurring in ≥5% of patients, were headache (lacosamide 18%, placebo 22%), dizziness (lacosamide 15%, placebo 8%), and nausea (lacosamide 12%, placebo 7%). Five lacosamide and 3 placebo patients withdrew for adverse events. Discussion Lacosamide seems to attenuate pain in diabetic neuropathy in doses up to 400 mg/d and improves quality of life issues." @default.
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• W2079286087 date "2007-02-01" @default.
• W2079286087 modified "2023-10-18" @default.
• W2079286087 title "Lacosamide in Painful Diabetic Peripheral Neuropathy" @default.
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• W2079286087 doi "https://doi.org/10.1097/01.ajp.0000210957.39621.b2" @default.
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