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Title: Lamotrigine Appears Safe in Infant Population With Partial Seizures: Presented at AES

"Lamotrigine Appears Safe in Infant Population With Partial Seizures: Presented at AES"

By Bonnie Darves NEW ORLEANS, LA -- December 9, 2004 -- The antiepileptic drug lamotrigine (Lamictal) appears to be well tolerated as long-term therapy for infants with partial seizures, according to a study reported here on December 7[^th at the American Epilespy Meeting Annual Meeting.

The study's lead author, Ricardo Ayala, MD, neurologist, Tallahassee Neurological Clinic, Tallahassee, Florida, United States, said that previous concerns about the prevalence of treatment-related rashes and infections in this population might have been overstated.

In the multicentre continuation study, patients aged 1 to 24 months who had achieved a 40% or great reduction in seizure frequency during the initial 27-week open-label study were randomised to receive up to 30 mg/kg daily of lamotrigine; the mean overall dose was 9.6 mg and 11.8 mg in the induced group. Mean age and weight were 13 months and 10.5 kg, respectively. Subjects who remained in the study were treated for up to 48 weeks or until their second birthday.

The majority of the 109 infants in the ongoing open-label study tolerated lamotrigine well as adjunctive therapy, and only 11 withdrew due to adverse events.

"Lamotrigine was well tolerated up to 30 mg per kilogram in these patients, and there was only rash that might have been [drug] related," Dr. Ayala said. "This is a safe drug."

He noted that there was one incidence of ventricular hypertrophy, which may or may not have been related to lamotrigine, and that six patients died during an 8-week continuation study from causes unrelated to the drug. An estimated 10 adverse events were deemed attributable to the drug, Dr. Ayala said.

The drug is approved for and has been found efficacious in adults and children over age 2 years who have either partial seizures or generalized seizures associated with Lennox-Gastaut syndrome.

The study was sponsored by GlaxoSmithKline.

[Presentation title: "Long-Term Safety of Lamotrigine in Pediatric Subjects With Partial Seizures." Abstract 2.371]

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