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Epilepsy Outcome at Four Years in a Randomized Clinical Trial Comparing Oral Prednisolone and Intramuscular ACTH in West Syndrome - 10/05/21

Doi : 10.1016/j.pediatrneurol.2021.01.008 
Jithangi Wanigasinghe, MD a, , Carukshi Arambepola, MD b, Shalini Sri Ranganathan, PhD c, Kasun Jayasundara, MBBS d, Ashangi Weerasinghe, MBBS a, Piyumi Wickramarachchi, MBBS a
a Faculty of Medicine, Department of Paediatrics, University of Colombo, Colombo, Sri Lanka 
b Faculty of Medicine, Department of Community Medicine, University of Colombo, Colombo, Sri Lanka 
c Faculty of Medicine, Department of Pharmacology, University of Colombo, Colombo, Sri Lanka 
d University Paediatric Unit, Lady Ridgeway Hospital, Colombo, Sri Lanka 

Communications should be addressed to: Dr. Wanigasinghe; Faculty of Medicine; Department of Paediatrics; University of Colombo; Colombo, Sri Lanka.Faculty of MedicineDepartment of PaediatricsUniversity of ColomboColomboSri Lanka

Abstract

Background

This article explores the role of initial treatment on control of spasms and other epilepsies at four years in children previously treated for West syndrome.

Methods

The Sri Lanka Infantile Spasm Study is a prospective clinical trial evaluating response to intra-muscular adrenocorticotropic hormone (ACTH) versus oral prednisolone. A previous report documented response through age 12 months. This article provides four-year follow-up data.

Results

At age four years, 65 of the original 97 were available for follow-up; another 13 had died, and 19 moved and could not be contacted. Of the 65 children, 37 (57%) continued to have seizures and 28 were seizure free. In the 37 children with ongoing epilepsy, 32.4% continued to have spasms, either alone or in combination with other seizure types. The epilepsy types seen in these children were focal epilepsy (59.4%), mixed focal and generalized epilepsy (24%), generalized epilepsy only (10.8%), and uncertain (5%). The majority of those still having epilepsy (66.7%) were controlled on medication. There was no significant difference in the rate of epilepsy or spasms or their control by medication between those treated with ACTH or oral prednisolone. Spasm control at day 14 did not influence the four-year spasm or epilepsy outcome.

Conclusions

A majority of children diagnosed with West syndrome continued to have seizures at age four years, although most were controlled on antiseizure medication. The long-term risk of developing epilepsy or its control was the same, regardless of whether ACTH or prednisolone was initially used as treatment.

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Keywords : Epileptic spasms, West syndrome, ACTH, Prednisolone, Epilepsy, Outcome, Infantile spasms


Plan


 Jithangi Wanigasinghe: Principal investigator of the project. Responsible for planning out the trial, obtaining funds, and overall conduct of the trial. She is also responsible for major proportion of the writing of the article. She takes full responsibility for the data and its accuracy and the conduct of the research. Carukshi Arambepola: Bio-statistician of the study. Responsible for the generation of data analysis and writing up of results in this article. Shalini Sri Ranganathan: Responsible for the therapeutic observations, follow-up on adverse effects, and contribution to development of the paper. Kasun Jayasundara: Responsible for organizing patient contact and evaluations. Ashangi Weerasinghe: Responsible for organizing patient contact and evaluations and data tabulations. Piyumi Wickramarachchi: Responsible for organizing patient contact and evaluations and data tabulations.
 Disclosures: No part of the trial was industry sponsored. The Sri Lanka Medical Association did part funding. The principal investigator currently holds an NIH grant (IR21HD093563-01) for research unrelated to epileptic spasms. None of the other authors have any conflicts of interest to declare. We confirm that we have read the journal’s position on issues involved in ethical publication and affirm that this report is consistent with those guidelines.


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Vol 119

P. 22-26 - juin 2021 Retour au numéro
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