Lacosamide Safe in Combination With Other Antiepileptic Drugs: Presented at ANA

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Title: Lacosamide Safe in Combination With Other Antiepileptic Drugs: Presented at ANA
URL: http://www.pslgroup.com/dg/22D52E.htm
Doctor's Guide
September 23, 2008

By Andrew N. Wilner, MD

SALT LAKE CITY, Utah -- September 23, 2008 – Dose-related central nervous system and gastrointestinal side effects were the most common adverse events that occurred during 3 clinical trials of lacosamide for partial-onset epilepsy presented here at the American Neurological Association (ANA) 133rd Annual Meeting.

Lacosamide, an investigational drug, is being reviewer by the US Food and Drug Administration for the treatment of partial-onset seizures and neuropathic pain. The drug has 2 novel mechanisms of action: It increases slow inactivation of sodium channels and binds to the collapsin-response mediator protein 2.

Interactions with other antiepileptic drugs are anticipated to be minimal because lacosamide has low potential to induce or inhibit cytochrome P450 enzymes, and protein binding is <15%, according to Victor Biton, MD, Arkansas Epilepsy Program, Little Rock, Arkansas, and colleagues, who presented the research on September 22.

The studies enrolled a total of 944 patients randomised to lacosamide and 364 patients randomised to placebo. The 3 randomised, double-blind, placebo-controlled clinical trials evaluated the adjunctive treatment of partial-onset seizures.

Patients were aged between 16 to 70 years, had a mean epilepsy duration of 24 years, and were taking 1 to 3 antiepileptic drugs.

Doses of lacosamide in these studies ranged from 200 to 600 mg/day. During the titration phase, doses were increased by 100 mg per week.

The most common adverse events were dizziness (31%), headache (13%), nausea (11%), and diplopia (10%). Less common adverse effects included vomiting, fatigue, abnormal coordination, blurred vision, tremour, and nystagmus.

In addition, a dose-related increase in PR interval was observed on the electrocardiogram (1.4 ms at 200 mg/day, 4.4 ms at 400 mg/day, and 6.6 ms at 600 mg/day). No significant electrocardiographic abnormalities or clinical arrhythmias occurred.

Adverse events tended to occur more frequently at higher doses and were more prevalent in the titration than in the maintenance phase of the trials.

Most adverse events were mild to moderate, but severe adverse events occurred in 10.7% of the lacosamide patients compared with 4.7% of placebo patients; 17% of patients dropped out of the studies because of adverse events.

According to the researchers, adverse effects on cognition and mood appeared minimal, and lacosamide did not affect body weight.

It was concluded that lacosamide was generally well tolerated even when combined with 3 other antiepileptic drugs.

Funding for this study was provided by UCB, Inc.

[Presentation title: Safety and Tolerability of Lacosamide: Summary of Adverse Events in Epilepsy Clinical Trials. Abstract M-72]

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