Authors' objectives: This report was initiated following a question formulated by the Pharmaceutical Service at the “ Punto de Europa” Hospital (Algeciras, Cadiz) regarding the use of antidigoxin antibodies, especially in cases of digitalis intoxication of the first type previously described. The objective was to review the indications for usage published on this therapeutic technology and evaluate their degree of scientific evidence.

Authors' recommendations: There is a very high level of concordance among the studies reviewed with regards to the indications for the use of the antidigoxin antibody Fab fragments compared to traditional treatment in severe acute accidental digoxin intoxications and in suicide attempts.Regarding those intoxications which result from different factors, in patients undergoing digitalis therapy and which tend to be of a less severe nature, the usual therapeutic approach is traditional treatment, and the assessment of the patient just in case it might prove to be necessary to use Fab fragments.According with the literature consulted, it would seem that the digoxin intoxication death rates have not decrease as much as might have been desired following the appearance of a drug so highly specific as Fab fragments.Several authors suggest that in high risk patients a more active approach in the use of Fab fragments is required in order to reduce the treatment failure rates and the digoxin intoxications high death rates which are still observed.Nonetheless, it is important to emphasise that none of the treatment regimes with antidigoxin antibody Fab fragments so far proposed have proven to be valid in a controlled, randomised clinical trial.What are needed are clinical trials to evaluate the effect of dose and the pattern of administration on the pharmacokinetics of the Fab fragments, and which also look into its use at different degrees of severity of digitalis intoxication.In the same vein, cost-effectiveness studies on the two therapeutic options would also be useful in cases of less severe intoxications in patients on digitalis therapy; and should not be confined to the analysis of the high cost of Fab fragments when deciding on the clinical indications for this drug.In any event, a protocol is necessary for the use of this drug and it must be consensuated by the practitioners at each hospital.

Project Status: Completed

URL for project: https://www.aetsa.org/publicacion/evaluacion-de-uso-de-anticuerpos-antidigoxina-en-la-intoxicacion-digitalica/

Year Published: 1998

URL for published report: https://www.aetsa.org/download/publicaciones/antiguas/AETSA_P_1998_Antidigoxina.pdf

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: Spain

Organisation Name: Andalusian Health Technology Assessment Area

Contact Address: Area de Evaluacion de Tecnologias Sanitarias Sanitarias de Andalucia (AETSA) Avda. Innovación, s/n Edificio Arena 1. Sevilla (Spain) Tel. +34 955 006 309

Contact Name: aetsa.csalud@juntadeandalucia.es

Contact Email: aetsa.csalud@juntadeandalucia.es

Copyright: Andalusian Agency for Health Technology Assessment (AETSA)