Vigabatrin-related adverse events for the treatment of epileptic spasms: systematic review and meta-analysis

Abstract

Objective: Although vigabatrin (VGB) is effective and well tolerated for the treatment of epileptic spasms, there are safety concerns. The aim of this systematic review and metaanalysis was to assess adverse events of VGB for the treatment of epileptic spasms. Methods: MEDLINE, EMBASE, and Cochrane databases were searched. The population was infants treated with VGB for epileptic spasms. The outcomes were VGB-related adverse events. Meta-analyses of VGB-related MRI abnormalities, retinal toxicity as measured by electroretinogram (ERG), visual field defect as measured by perimetry, and other adverse events were conducted. Results: Fifty-seven articles were included in the systematic review. The rate of VGB-related MRI abnormalities was 21% (95% CI: 15-29%). Risk factors for MRI abnormalities were age younger than 12 months and higher VGB dose. VGB-related retinal toxicity and visual field defect occurred in 29% (95% CI: 7-69%) and 28% (95% CI: 4-78%) respectively. Other adverse events occurred in 23% (95% CI: 16-34%), consisting predominantly of central nervous system symptoms, and the majority of these did not require therapeutic modification. Conclusion: This study will inform physicians and families on the risk profile of VGB for the treatment of epileptic spasms and will help decisions on treatment options.

Keywords: Epileptic spasm; MRI; adverse effects; electroretinogram; retinal toxicity; vigabatrin; visual field defect.