Lacosamide Shows Impressive Safety Profile In Painful Diabetic Neuropathy

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Main Category: Diabetes
Also Included In: Pain / Anesthetics;  Neurology / Neuroscience
Article Date: 16 Apr 2008 - 9:00 PDT

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Lacosamide is generally safe and well tolerated when used to treat patients with painful diabetic neuropathy, investigators announced here at the 60th Annual Meeting of the American Academy of Neurology (AAN).

Lacosamide (LCM) is an anticonvulsant under investigation for its potential effect in decreasing diabetic neuropathic pain. The drug is believed to exert its positive therapeutic effects through a unique dual mechanism of action.

James Wymer, MD, Medical Director of Upstate Clinical Research in Albany, New York, presented the results of pooled safety data from four phase II/III trials of patients with painful diabetic neuropathy.

Overall, 1,023 patients were randomized to lacosamide (200 mg/day, 400 mg/day, or 600 mg/day), and 291 patients to placebo. Most patients were treated for lacosamide for 92 to154 days.

The placebo and lacosamide groups were well matched with respect to diabetes control, baseline pain, and concomitant medications at baseline. Most patients had received prior treatment for painful diabetic neuropathy.

Results showed that the overall percentage of subjects who stopped treatment prematurely was similar in the placebo, lacosamide 200 mg/day, and lacosamide 400 mg/day groups (24.7%, 29.9%, and 32.9%, respectively) and higher in the lacosamide 600 mg/day group (55.4%), Dr. Wymer said.

Adverse events accounted for nearly one-fifth of cases of early discontinuation of treatment.

Treatment- emergent adverse events were reported by 72.9% of placebo-treated patients and 76.3% of the lacosamide-treated patients.

In the pooled lacosamide treatment groups, the most common treatment-related adverse events were dizziness (16.4% of lacosamide patients, 5.2% of placebo patients), nausea (10.3% vs. 6.2%), headache (9.3% vs. 9.6%), fatigue (6.6% vs. 4.1%), and tremor (6.4% vs. 1.0%).

The incidence rates of somnolence were notably low (4.7% for lacosamide and 1.4% for placebo).

Lacosamide use was not associated with relevant changes in body weight.

"Overall, the results show that lacosamide has a favorable side effect profile comparable to placebo at doses up to 400 mg/day," Dr. Wymer commented.

http://www.schwarzpharma.com

Written by - Jill Stein
Jill Stein is a Paris-based freelance medical writer.
jillstein03(at)gmail.com
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