Adverse Events From Lacosamide Are Dose-Related: Presented at ANA

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Title: Adverse Events From Lacosamide Are Dose-Related: Presented at ANA
URL: http://www.pslgroup.com/dg/22D526.htm
Doctor's Guide
September 23, 2008

By Andrew N. Wilner, MD, FACP, FAAN

SALT LAKE CITY, Utah -- September 23, 2008 -- Lacosamide for diabetic neuropathic pain is better tolerated at relatively lower doses, according to research from four randomised clinical trials 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. Three phase 3 trials (SP742, SP743, and SP768) and one phase 2 trial (SP614) included a total of 1,023 diabetic patients with neuropathic pain treated with lacosamide, explained lead investigator James Wymer, MD, Upstate Clinical Research, Albany, New York, presenting at a poster session on September 22.

All subjects had pain intensity of at least 4 on an 11-point Likert Scale.

The trials lasted from 4 to 12 weeks, and lacosamide dosing ranged from 200 to 600 mg/day. Lacosamide was administered beginning at 50 mg twice daily. Patients on standard titration had their doses increased weekly by 100 mg/day.

The occurrence of adverse events was similar among patients taking lacosamide (76.4%) and those on placebo (72.9%).

Adverse events that occurred in more than 5% of patients and were more common in the lacosamide-treated subjects compared with placebo subjects included dizziness (16.3%), nausea (10.3%), fatigue (6.7%) and tremour (6.5%). These adverse events tended to increase in incidence with increase in lacosamide dose. At 600 mg/day, the incidence of adverse events was dizziness (25.3%), nausea (14.9%), fatigue (7.7%), and tremour (9.4%).

Additional adverse events that occurred in more than 5% of the group taking lacosamide 600 mg/day included somnolence (5.8%), vertigo (7.2%), and balance disorder (5.5%).

Adverse events were more common in the titration phase than the maintenance phase, the researchers noted. Cognitive and psychiatric disorders experienced in the treatment group were similar to those seen in the placebo group. No clinically relevant changes in vital signs or laboratory values (haematology, chemistry, urinalysis) were observed.

On electrocardiography, a dose-related increase in PR interval was observed: placebo group (-2.2 ms), lacosamide 200-mg/day group (+4.5 ms), 400-mg/day group (+8.6 ms), and 600-mg/day group (+9.4 ms). First-degree AV block occurred in 0.5% of lacosamide patients compared with 0% on placebo.

Lacosamide did not consistently affect a change in body weight.

Study discontinuation due to adverse effects occurred in the groups as follows: placebo (8%), lacosamide 200 mg/day (11%), 400 mg/day (16%), and 600 mg/day (34%). Dizziness and nausea were the adverse events most often related to study discontinuation, and most discontinuations due to adverse effects (78%) occurred during the titration phase. There was no benefit to slow titration versus fast titration with respect to lacosamide tolerability or the incidence of adverse events.

The mean age of subjects in this study was approximately 59 years, and there were slightly more males than females. Approximately 29% of subjects were aged 65 years or older. Comorbidities were common: 68% had hypertension, 26% had hypercholesterolaemia, and 20% had hyperlipidaemia.

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

[Presentation title: Safety Summary of Lacosamide for Treatment of DNP. Abstract IM-101]

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