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
• vigabatrin
• adverse effects
• MRI
• electroretinogram
• visual field defect
• retinal toxicity

Article highlights

• Rate of VGB-related MRI abnormalities is 21%, with the basal ganglia being the most common structure involved

• Risk factors for MRI abnormalities include age 12 months and VGB dose > 170 mg/kg/day

• VGB-related MRI abnormalities are reversible in 88% of patients

• Longer duration of treatment is a risk factor for VGB-related retinal toxicity

• Other adverse events occur in 23% of patients, comprising predominantly of CNS symptoms, with majority not requiring therapeutic modification

Acknowledgments

The authors would like to thank Quenby Mahood, librarian at the Hospital for Sick Children, for assisting with the literature search.

Declaration of interest

A Vincent is supported by Foundation Fighting Blindness, USA (CD-CL-0617-0727-HSC). The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or conflict with the subject matter or materials discussed in this manuscript apart from those disclosed.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Supplementary material

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Additional information

Funding

This paper was not funded.