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The Expert Consensus Guideline Series: Treatment of Epilepsy (2001)

Karceski S, Morrell M, and Carpenter D. The expert consensus guideline series: treatment of epilepsy. Epilepsy & Behavior 2001;2:A1-A50.

For second monotherapy:
Experts recommended LAMICTAL for conversion from carbamazepine or phenytoin in adults with partial seizures

The experts

51 leading physicians in epilepsy treatment, selected on the basis of recent publications and representing a geographic cross-section of the United States (45 responded)

The objective

• To identify an overall approach to treatment, experts were asked to rank the order in which they would recommend certain therapies

• Using a modified 9-point scale (developed by the Rand Corporation), experts were asked to rate specific treatment choices

The survey

• Designed to address key decision points in the management of epilepsy and seizures

• Contained 21 questions about 808 treatment options covering four main clinical scenarios:
- idiopathic generalized epilepsy
- partial seizures (symptomatic localization-related epilepsy) - symptomatic generalized epilepsy
- status epilepticus

Data analysis

Consensus was established for three ranges of appropriateness (1-3, 4-6, 8-9) according to a chi-square test of the distribution of scores:

•   First line: confidence interval (CI) >6.5

•   Second line: CI 3.5 to 6.49

•   Third line: CI <3.5

The question

Partial seizures (symptomatic localization-related epilepsy): second monotherapy: Suppose that the first therapy is tried to clinical tolerance and produces either no reduction of seizures or only a limited response. Assume you would next choose a second monotherapy trial and that the antiepileptic medication shown at the top of each section is your first choice. Please rate the appropriateness of each of the following therapies as a second monotherapy in this situation.

The results

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% of physicians who recommended conversion to LAMICTAL as second monotherapy

• Safety and effectiveness of LAMICTAL have not been established 1) as initial monotherapy, 2) for conversion to monotherapy from AEDs other than carbamazepine, phenytoin, phenobarbital, primidone, or valproate, or 3) for simultaneous conversion to monotherapy from 2 or more concomitant AEDs

The Expert Consensus Guideline Series: Treatment of Epilepsy was sponsored by unrestricted educational grants from Abbott Laboratories, GlaxoSmithKline, and Novartis Pharmaceuticals. The opinions expressed in this survey are those of the expert panel. Dosages, indications, and methods of use referred to in the guideline may reflect the clinical experience of the editors, professional literature, or other clinical sources.

Important Safety Information

•

Serious rashes requiring hospitalization and discontinuation of treatment have been reported in association with the use of LAMICTAL, some of which have included Stevens-Johnson syndrome

Epilepsy clinical trials: The incidence of these rashes is approximately 0.8% (8/1000) in pediatric patients (age <16 years) receiving LAMICTAL as adjunctive therapy and 0.3% (3/1000) in adults on adjunctive therapy. In a prospectively followed cohort of 1983 pediatric patients taking adjunctive LAMICTAL, there was 1 rash-related death

•

In worldwide postmarketing experience, rare cases of toxic epidermal necrolysis and/or rash-related death have been reported in adult and pediatric patients, but their numbers are too few to permit a precise estimate of the rate

•

Hypersensitivity reactions, some fatal or life-threatening, have occurred in association with the use of LAMICTAL. It is important to note that early manifestations of hypersensitivity (eg, fever, lymphadenopathy) may be present even though a rash is not evident. If such signs or symptoms are present, the patients should be evaluated immediately. LAMICTAL should be discontinued if an alternative etiology cannot be established

•

Prior to initiation of treatment with LAMICTAL, the patient should be instructed that a rash or other signs or symptoms of hypersensitivity (eg, fever, lymphadenopathy) may herald a serious medical event and that the patient should report any such occurrence to a physician immediately

•

To avoid an increased risk of rash, the recommended initial dose and subsequent dose escalations of LAMICTAL should not be exceeded

•

LAMICTAL should ordinarily be discontinued at the first sign of rash, unless the rash is clearly not drug-related

Complete Prescribing Information for LAMICTAL^® (lamotrigine) Tablets

For the latest medical updates on epilepsy treatment, visit the American Epilepsy Society, the American Academy of Neurology, and the Child Neurology Society.

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