Title: Lacosamide in Painful Diabetic Peripheral Neuropathy: A Phase 2 Double-blind Placebo-controlled Study
Authors: Richard L. Rauck, MD, Aziz Shaibani, MD, Victor Biton, MD, Jeff Simpson, PhD, and Brigitte Koch, PhD
Source: The Clinical Journal of Pain 23 (2) : 150-158 Feb 2007
PODIATRIC RELEVANCE:
Painful peripheral neuropathy is a common complication of diabetes affecting between 20% and 45% of patients with diabetes. Patients often present to their podiatrists with complaints of peripheral neuropathic pain. It is important that practitioners are aware of the current and potential future medical treatments of this condition. The article summarized below investigates the anticonvulsant Lacosamide in treating painful diabetic peripheral 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 this multicenter, randomized, double-blind, placebo-controlled trial. Lacosamide (N = 60) titrated from 100 to 400 mg/d or maximum tolerated dose and placebo (N = 49) 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.
RESULTS:
Ninety-four patients (lacosamide 46; placebo 48) completed this 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 were headache (lacosamide 18%, placebo 22%), dizziness (lacosamide 15%, placebo 8%), and nausea (lacosamide 12%, placebo 7%).
COMMENTS:
There is currently no single drug that appears to work for all patients with peripheral diabetic neuropathy. Lacosamide is a new anticonvulsant under investigation in pain relief indications. This drug offers another potential alternative for treatment of diabetic peripheral neuropathy. There were some limitations in this study. For one, the diagnosis of diabetic neuropathy was made on clinical examination alone without the use of nerve electrophysiology studies. There was also an unexpected high rate of adverse events in placebo group. The power of the placebo response is also an important aspect as responses were subjective evaluations. However, this trial may be considered as preliminary evidence for efficacy of Lacosamide as a treatment of painful diabetic peripheral neuropathy.
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Disclaimer:
Scientific Abstract Monthly postings are submitted by podiatric surgical residents. The ideas presented are not the opinions of the American College of Foot and Ankle Surgeons (ACFAS), nor are they presented as facts. ACFAS presents this information without any warranty of any kind, expressed or implied, and is not liable for its accuracy nor for any loss or damage caused by the user's reliance on information obtained in these areas.