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Vigabatrin for infantile spasms.

Kimberly A Pesaturo1, Linda M Spooner, Paul Belliveau

  • 1Department of Pharmacy Practice, Massachusetts College of Pharmacy and Health Sciences-Worcester/Manchester, Worcester, Massachusetts 01608, USA. kimberly.pesaturo@mcphs.edu

Pharmacotherapy
|March 3, 2011
PubMed
Summary
This summary is machine-generated.

Vigabatrin is an effective treatment for infantile spasms, a serious pediatric epilepsy. However, its use is limited by potential visual side effects and the need for further research comparing it to hormone therapy.

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Area of Science:

  • Pediatric Neurology
  • Epileptology
  • Pharmacology

Background:

  • Infantile spasms (IS) are a severe pediatric epilepsy syndrome often linked to developmental delays.
  • West syndrome is diagnosed when IS is accompanied by hypsarrhythmia on electroencephalogram (EEG).
  • Adrenocorticotropic hormone (ACTH) is the traditional mainstay treatment for IS.

Purpose of the Study:

  • To review the existing clinical trial data on vigabatrin for infantile spasms.
  • To assess the efficacy and limitations of vigabatrin as a treatment for IS.
  • To compare vigabatrin with ACTH as a first-line therapy for IS.

Main Methods:

  • Review of published clinical trials on vigabatrin for infantile spasms.
  • Analysis of trial limitations, including small sample sizes and lack of control groups.
  • Consideration of vigabatrin's black-box warning regarding visual field defects.

Main Results:

  • Vigabatrin has demonstrated utility in treating infantile spasms, particularly in Europe since 1989 and FDA-approved in the US since 2009.
  • Many existing trials are limited by small size, open-label design, or lack of control groups.
  • Vigabatrin carries a black-box warning for potential permanent visual field defects.

Conclusions:

  • Despite its effectiveness, the optimal role of vigabatrin versus hormone therapy for IS remains unclear.
  • Further comparative research is necessary to determine if vigabatrin should supersede hormone therapy as first-line treatment.
  • Vigabatrin is available via a Risk Evaluation and Mitigation Strategy (REMS) program due to safety concerns.