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| |  Paediatric Patients With Absence Epilepsy Show High Seizure-Free Rates on Lamotrigine as Monotherapy: Presented at AES By John Otrompke BOSTON -- December 10, 2009 -- Two trials, conducted 10 years apart, demonstrate the clinical efficacy of lamotrigine in treating childhood absence epilepsy, a form of the disease characterised by frequent staring spells, according to research presented here December 7 at the American Epilepsy Society (AES) 63rd Annual Meeting. “The second trial -- LAM100118 -- was designed to raise 3 questions raised by the first trial -- US44 -- 10 years earlier,” said John Messenheimer, MD, GlaxoSmithKline, Research Triangle Park, North Carolina. The first question was whether a longer maintenance period, which followed the dose-escalation period in both studies, would result in decreased seizure freedom. In the latter trial, the maintenance period was 12 weeks, compared with 4 weeks; seizure freedom actually increased from 64% to 78%. The second question, according to Dr. Messenheimer, was whether patients would still enjoy a therapeutic response if the dose were escalated more slowly. In the US44 trial, the dose was increased to a maximum of 15 mg/kg/day for 17 weeks, compared with a maximum dose of 10 mg/kg/day over 20 weeks in the LAM100118 trial.(1,2) Although the seizure-free rate during escalation was only 56% in the later trial compared with 71% in the first trial, patients still experienced a therapeutic response. The third question was whether patients would experience a lower rate of seizure freedom during the escalation phase, and a higher rate during the maintenance phase, if the dose were raised 1 extra level following the first seizure-free examination. In the 2 studies, a total of 99 patients were administered lamotrigine for childhood absence epilepsy. The US44 trial, reported in 1999, enrolled subjects ages 2 to 16 years, while the LAM100118 trial enrolled only patients under 13 years. The mean age of patients in both trials was between 7.3 and 7.4 years old, and two-thirds of the patients in both trials were female. Patients were tested by hyperventilation-electroencephalogram (EEG). “We had the child breath rapidly to simulate hyperventilation, for 3 to 5 minutes,” Dr. Messenheimer explained. Hyperventilation provokes the seizures if the child is still epileptic, but the EEG is necessary to establish the condition, because absence seizures are subtle in nature. Patients in the combined studies enjoyed a rate of freedom from seizures of 44%. There was a gap of 10 years between the 2 trials, because the US Food & Drug Administration became concerned about the issue of toxic epidermal necrolysis, a life-threatening, burn-like rash associated with antiepileptic drugs, Dr. Messenheimer explained. While there were no cases of serious rash in the 2 trials discussed, there were several serious adverse events. The first adverse event, a suicide attempt, occurred in a 15-year-old patient. “All antiepilepsy drugs have been associated with increased risk of suicide,” explained Dr. Messenheimer. The second adverse event was a case of gastroenteritis. In the third patient, an increased number of absence seizures prompted the patient to change drugs. Funding for this study was sponsored by GlaxoSmithKline. 1. Frank LM et al. Epilepsia. 1999;40:973-979. [Presentation title: Estimated Rate for Achieved and Maintained Seizure Freedom With Lamotrigine Monotherapy for Newly-Diagnosed Absence Epilepsy Using Results From Two Similar Trials. Abstract 3.182]
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