Long-Term Safety Features of Lacosamide Similar to Those for Short-Term Use: Presented at AES
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Long-Term Safety Features of Lacosamide Similar to Those for Short-Term Use: Presented at AES

By John Otrompke

BOSTON -- December 9, 2009 -- Long-term use of lacosamide carries similar health and safety risks to short-term use of the drug, according to a study presented here at the American Epilepsy Society (AES) 63rd Annual Meeting.

In general, no new treatment-related adverse effects emerged with long-term use of the drug. However, 4.7% of patients reported experiencing severe dizziness with lacosamide.

Perhaps surprisingly, however, there were no deaths in long-term users of the drug that were considered to be treatment related, according to William Rosenfeld, MD, Comprehensive Epilepsy Care Center for Children and Adults, St. Louis, Missouri.

“We report on all of the different centres around the country,” said Dr. Rosenfeld, who presented the poster on December 6. In addition to dizziness, 1.5% of patients withdrew from using the drug due to coordination problems, and 1.5% withdrew due to blurry vision.

In the study, 1,327 patients taking lacosamide were followed for up to 7 years. As of April 2009, 40% were still using the drug.

As of the interim analysis, 91.3% of patients reported at least 1 treatment-related adverse event. Overall, 45.6% of patients reported dizziness, 18.5% reported double vision, 14.1% reported vomiting, 12.5% reported abnormal coordination, and 12% reported blurry vision. Other problems reported included tremors (11.5%), convulsions (11.4%), and contusions (10.4%).

“These are all intractable patients, with difficult-to-control epilepsy, who have tried between 3 and 18 different drugs for partial-onset seizures in their lives,” said Dr. Rosenfeld. The mean duration of treatment with lacosamide for patients in the trial was 733 days, he added.

While the drug is approved for dosage up to 400 mg/day, some intractable patients in the trial received as much as 600 to 800 mg/day. The most common modal dose was 400 mg/day (26.1%), with 8.4% receiving between 600 and 800 mg/day.

“In adults, 80% of seizures are partial or focal in onset,” Dr. Rosenfeld explained. “Some are partial simple seizures, in which there is no alteration of consciousness, but just a funny feeling or a partial movement of the body.”

A small increase in cardiac PR levels was seen on electrocardiogram reading, but there were no cases of second- or third-degree heart block.

Funding for this study was provided by UCB.

[Presentation title: Long-Term Safety and Tolerability of Lacosamide for Partial-Onset Seizures: An Interim Evaluation of Patients Exposed to Lacosamide in Double-Blind and Open-Label Trials. Abstract 2.231]

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