Lacosamide Decreases Peripheral Neuropathic Pain in Diabetics: Presented at ANA

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Title: Lacosamide Decreases Peripheral Neuropathic Pain in Diabetics: Presented at ANA
URL: http://www.pslgroup.com/dg/22D5D2.htm
Doctor's Guide
September 24, 2008

By Andrew N. Wilner, MD, FACP, FAAN

SALT LAKE CITY, Utah -- September 24, 2008 -- Lacosamide significantly decreases the pain of diabetic neuropathy, according to results of a European trial presented at the American Neurological Association (ANA) 133rd Annual Meeting.

Lacosamide is an investigational drug for the treatment of diabetic neuropathic pain and partial-onset seizures. More than two-thirds of the subjects in this study (67.6%) had tried at least 1 medication for their diabetic neuropathic pain, according to the researchers, led by Sabine Bongardt, MD, PhD, Schwarz Biosciences GmbH (a member of the UCB Group), Monheim, Germany.

Subjects eligible for enrolment in this multicentre, double-blind, randomised, placebo-controlled trial included adults with type 1 or 2 diabetes, haemoglobin A1C <12%, diabetic neuropathic pain for at least 6 months but less than 5 years, and a score of at least 4 on an 11-point Likert pain scale.

The 549 subjects who enrolled were divided into 3 study arms: placebo (n = 179), slow titration (n = 181), and fast titration (n = 189), the researchers noted at a poster presentation here on September 22.

At baseline, the subjects in all 3 groups had approximately a 3-year history of pain and similar pain scores. After a 7-day baseline period, patients were titrated to lacosamide 400 mg/day and maintained on that dose for 12 weeks. Titration was performed over 1 week in the fast-titration arm and over 4 weeks (100 mg/week) in the slow-titration arm.

Patients in the slow-titration arm had a small but significant decrease in pain compared with placebo, with a decrease of 0.45 points on the 11-point pain scale (P = .04). Of the patients who achieved pain relief, 60% did so within 3 days and 96% within 2 weeks. Although patients in the fast-titration arm had a slight decrease of pain compared with placebo (-0.23 points on the 11-point scale), this was not statistically significant.

The most common adverse events were dizziness, nausea, headache, vertigo, and nasopharyngitis.

In addition, 6.7% of treatment subjects developed first-degree AV block (defined as a PR interval >209 ms), compared with 3.0% of placebo patients. No cardiac side effects related to the first-degree AV block were reported.

Adverse effects were responsible for study discontinuation in 6.7% of placebo subjects, 8.8% of the slow-titration arm, and 15.9% of the fast-titration arm.

The authors concluded that there was no advantage to the fast titration of lacosamide in terms of efficacy or tolerability in the treatment of diabetic neuropathic pain.

Funding for this study was supported by UCB Pharma, Inc.

[Presentation title: Lacosamide Reduces Pain in Subjects With Diabetic Neuropathy. Abstract IM-88]

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