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Titre du document / Document title

Sudden unexplained death in epilepsy : Observations from a large clinical development program

Auteur(s) / Author(s)

LEESTMA J. E. (1) ; ANNEGERS J. F. (2) ; BRODIE M. J. (3) ; BROWN S. (4) ; SCHRAEDER P. (5) ; SISCOVICK D. (6) ; WANNAMAKER B. B. (7) ; TENNIS P. S. (8) ; CIERPIAL M. A. (8) ; EARL N. L. (8) ;

Affiliation(s) du ou des auteurs / Author(s) Affiliation(s)

(1) Chicago Institute of Neurosurgery and Neuroresearch, Chicago, Illinois, ETATS-UNIS
(2) University of Texas, Houston, Houston, Texas, ETATS-UNIS
(3) University of Glasgow, Glasgow, Scotland, ROYAUME-UNI
(4) David Lewis Centre for Epilepsy, Cheshire, ROYAUME-UNI
(5) Robert Wood Johnson Medical School, Camden, New Jersey, ETATS-UNIS
(6) Cardiovascular Health Research Unit, University of Washington, Seattle, Washington, ETATS-UNIS
(7) Carolina Neurological Clinic, Charleston, South Carolina, ETATS-UNIS
(8) Burroughs Wellcome, Research Triangle Park, North Carolina, ETATS-UNIS

Résumé / Abstract

Purpose: The present study was conducted to determine the rate of sudden unexplained death in epilepsy (SUDEP) in a well-defined cohort of patients included in the lamotrigine (LTG) clinical development database. Methods: A panel of scientists experienced in the area of SUDEP was assembled and provided with case summaries on all deaths (n = 45) reported during the initial clinical development of LTG. The panel developed a set of criteria for classifying cases as SUDEP (definite or highly probable), possible SUDEP, or non-SUDEP. This classification algorithm was then applied to the LTG cases, and SUDEP rates were calculated using patient-years of exposure as the denominator. Results: At the time of the study, 4,700 patients (5,747 patient-years of exposure) were included in the worldwide LTG clinical trials database. In this cohort, 45 deaths were reported. Eighteen were judged by the panel to be SUDEP, 6 were defined as possible SUDEP, 20 were judged to be due to other causes (non-SUDEP), and I lacked sufficient data from which to make a classification. The overall SUDEP rate (definite/ highly probable SUDEP and possible SUDEP combined) was calculated to be 3.5 in 1,000 patient-years of exposure to LTG. Conclusions: The rate of SUDEP in this cohort of patients was comparable to the rate that would be expected in young adults with severe epilepsy (the subgroup of patients believed to be at highest risk of SUDEP). The data suggest that the rate of SUDEP in the LTG clinical development program is a function of the clinical trial population and is unrelated to drug treatment.

Revue / Journal Title

Epilepsia    ISSN  0013-9580   CODEN EPILAK 

Source / Source

1997, vol. 38, no1, pp. 47-55 (23 ref.)

Langue / Language

Anglais

Editeur / Publisher

Wiley-Blackwell, Malden, MA, ETATS-UNIS  (1909) (Revue)

Mots-clés anglais / English Keywords

Sudden death

;

Epilepsy

;

Partial

;

Refractory

;

Lamotrigine

;

Anticonvulsant

;

Exposure time

;

Dose

;

Treatment

;

Chemotherapy

;

Epidemiology

;

Complication

;

Cohort study

;

Human

;

Nervous system diseases

;

Central nervous system disease

;

Cerebral disorder

;

Mots-clés français / French Keywords

Mort subite

;

Epilepsie

;

Partiel

;

Réfractaire

;

Lamotrigine

;

Anticonvulsivant

;

Temps exposition

;

Dose

;

Traitement

;

Chimiothérapie

;

Epidémiologie

;

Complication

;

Etude cohorte

;

Homme

;

Système nerveux pathologie

;

Système nerveux central pathologie

;

Encéphale pathologie

;

Mots-clés espagnols / Spanish Keywords

Muerte súbita

;

Epilepsia

;

Parcial

;

Refractario

;

Lamotrigina

;

Anticonvulsivante

;

Tiempo exposición

;

Dosis

;

Tratamiento

;

Quimioterapia

;

Epidemiología

;

Complicación

;

Estudio cohorte

;

Hombre

;

Sistema nervioso patología

;

Sistema nervosio central patología

;

Encéfalo patología

;

Localisation / Location

INIST-CNRS, Cote INIST : 1145, 35400006321344.0050

Nº notice refdoc (ud4) : 2579465



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