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Titolo:
Interim report on the incidence of visual field defects in patients on long term vigabatrin therapy
Autore:
Wilton, LV; Stephens, MDB; Mann, RD;
Indirizzi:
Drug Safety Res Unit, Southampton SO31 1AA, Hants, England Drug Safety ResUnit Southampton Hants England SO31 1AA A, Hants, England Univanduthampton, Fac Med Hlth & Biol Sci, Southampton SO9 5NH, Hants, Engl Univ Southampton Southampton Hants England SO9 5NH n SO9 5NH, Hants, Engl
Titolo Testata:
PHARMACOEPIDEMIOLOGY AND DRUG SAFETY
, volume: 8, anno: 1999, supplemento:, 1
pagine: S9 - S14
SICI:
1053-8569(199904)8:<S9:IROTIO>2.0.ZU;2-G
Fonte:
ISI
Lingua:
ENG
Keywords:
visual field defect; vigabatrin; long latency; incidence; prescription-event monitoring; long term follow up; validation;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Clinical Medicine
Citazioni:
13
Recensione:
Indirizzi per estratti:
Indirizzo: Wilton, LV Drugants,ty Res Unit, Bursledon Hall,Blundell Lane, SouthamptonSO31 1AA, H Drug Safety Res Unit Bursledon Hall,Blundell Lane Southampton Hants England SO31 1AA
Citazione:
L.V. Wilton et al., "Interim report on the incidence of visual field defects in patients on long term vigabatrin therapy", PHARMA D S, 8, 1999, pp. S9-S14

Abstract

The incidence was determined of visual field defects in patients in the Prescription-Event Monitoring (PEM) study, treated for greater than or equal to 6 months with the antiepileptic drug vigabatrin. Questionnaires were sent to the general practitioners of the 7228 patients in the PEM study, treated with vigabatrin for greater than or equal to 6 months, to ascertain whether any serious adverse events, including changes in vision, had occurred. Ophthalmologists were asked to give the results of the perimetry tests and their opinion of the cause of the visual field defect for those patients referred to them. 6793 (94%) of the 7228 questionnaires were returned. 5090 (75%) contained clinical data. 328 patients were deceased. Seventy seven cases identified from the 4762 surviving patients, are being followed up with ophthalmologists, To date, 2 weeks after posting, 12 cases of visual field defect have been confirmed by formal perimetry tests. Ten of these 12 were considered to be probably or possibly related to vigabatrin use, giving an incidence of 2.0 per 1000 patients compared with 0.4 per 1000 patients in the original PEM cohort. These interim results show a substantial increase in the incidence of visual field defects associated with long term use of vigabatrin and demonstrate that PEM can be used to assess long latency adverse events. Copyright (C) 1999 John Wiley & Sons, Ltd.

ASDD Area Sistemi Dipartimentali e Documentali, Università di Bologna, Catalogo delle riviste ed altri periodici
Documento generato il 04/04/20 alle ore 11:10:24