Diabetic neuropathy lacosamide

In August 2008, lacosamide was granted market authorization by the European Commission as an adjunctive therapy for partial-onset seizures with or without secondary generalization. It was approved by the FDA as an adjunctive therapy for partial-onset seizures in October 2008 [129 ]. It is also effective against neuropathic pain attributed to distal diabetic neuropathy [130 ]. It is available as oral or intravenous formulations. 

In an open study of lacosamide in 69 patients with painful diabetic neuropathy the initial dose was followed by escalation by 100 mg/day up to a maximum of 400 mg/day [132 ]. Patients then entered a 20-week maintenance period after which they could opt to continue for up to about 2.5 years. The most commonly reported adverse events that were considered possibly related to the trial medication were headache (7%), dizziness (7%), tremor (4%), fatigue (6%), and diarrhea and nausea (4%). The adverse events occurred most often during the titration period. Seven patients withdrew because of adverse effects—electrocardiographic changes (n =2), dizziness and nausea (n = 1), chest pain and nausea (n = 1), dizziness, fatigue, and tinnitus (n = 1), possible stroke and convulsion (n = 1, this was considered a serious adverse event), accidental overdose (n = 1). 

In a double-blind, randomized, placebo-controlled trial, oral lacosamide (200, 400, and 600 mg/day) was given to 654 patients with painful diabetic neuropathy for 12 weeks after a 6-week dose titration period [135 ]. The proportions of patients with treatment-emergent adverse effects that were considered to be at least possibly related to the trial medication were 31 % for placebo, 39% for lacosamide 200 mg/day, 53% at 400 mg/day, and 68% at 600 mg/day. The most common included dizziness (n = 3, 8, 27, and 39 in those treated with placebo, lacosamide 200, 400, and 600 mg/day... 

In a multicenter, randomized, placebo-controlled, double-blind trial in 495 patients with painful diabetic neuropathy who took lacosamide 200, 400, or 600 mg/day for 12 weeks after a 6-week titration phase, the lacosamide 400 mg/day group had significant improvement in the primary efficacy measure [136 ]. The most common treatment-emergent adverse events included dizziness, nausea, fatigue, headache, and tremor and all appeared to be dose-related. For example, the incidence of dizziness was 5% at 400 mg/day and 22% at 600 mg/day. There was nausea in 5% of patients taking 400 mg/day and 12% of those taking... 

Shaibani A, Biton V, Rauck R, Koch B, Simpson J. Long-term oral lacosamide in painful diabetic neuropathy a two-year open-label extension trial. Eur J Pain 2009 13(5) 458-63. 

Shaibani A, Fares S, Selam JL, Arslanian A, Simpson J, Sen D, Bongardt S. Lacosamide in painful diabetic neuropathy an 18-week doubleblind placebo-controlled trial. J Pain 2009 10(8) 818-28. 

Rauck RL, Shaibani A, Biton V, Simpson J, Koch B. Lacosamide in painful diabetic peripheral neuropathy a phase 2 double-blind placebo-controlled study. Chn J Pain 2007 23(2) 150-8. 

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