Registry initiated to characterize vision loss associated with vigabatrin therapy

John M. Pellock, Edward Faught, Robert C. Sergott, W. Donald Shields, Gregory A. Burkhart, Gregory L. Krauss, Rod Foroozan, David L. Wesche, Mark A. Weinberg

Research output: Contribution to journalArticle

Abstract

The vigabatrin patient registry was implemented in August 2009 in conjunction with Food and Drug Administration approval of vigabatrin. All US vigabatrin-treated patients must enroll in the registry. Data on prescriber specialty/location, patient demographics, and clinical characteristics are collected. Benefit-risk assessments are required early in the course of therapy. Vision assessments are required at baseline (≤ 4. weeks after therapy initiation), every 3. months during therapy, and 3 to 6. months after discontinuation. As of February 1, 2011, 2473 patients (1500 with infantile spasms, 846 with refractory complex partial seizures, 120 with other diagnoses) had enrolled; 30.4% were previously exposed to vigabatrin. Kaplan-Meier analysis of time in registry indicated that 83 and 97% of all enrolled patients with refractory complex partial seizures and infantile spasms remained beyond 3 and 1. month, respectively. The ongoing registry will provide visual status and other information on vigabatrin-treated patients for both the infantile spasm and refractory complex partial seizure indications.

Original languageEnglish (US)
Pages (from-to)710-717
Number of pages8
JournalEpilepsy and Behavior
Volume22
Issue number4
DOIs
StatePublished - Dec 1 2011

Keywords

  • Epilepsy
  • Peripheral visual field defect
  • Risk evaluation and mitigation strategy
  • Sabril
  • Safety

ASJC Scopus subject areas

  • Neurology
  • Clinical Neurology
  • Behavioral Neuroscience

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