Vigabatrin-related adverse events for the treatment of infantile spasms: systematic review and meta-analysis
Abstract number :
351
Submission category :
7. Antiepileptic Drugs / 7D. Drug Side Effects
Year :
2020
Submission ID :
2422696
Source :
www.aesnet.org
Presentation date :
12/6/2020 12:00:00 PM
Published date :
Nov 21, 2020, 02:24 AM
Authors :
Asthik Biswas, The Hospital for Sick Children; Omar Yossofzai - The Hospital for Sick Children; Ajoy Vincent - The Hospital for Sick Children; Cristina Go - The Hospital for Sick Children; Elysa Widjaja - Hospital for Sick Children;;
Rationale:
Although vigabatrin (VGB) is effective and well-tolerated for the treatment of infantile spasms, there are safety concerns. The aim of this systematic review and meta-analysis was to assess adverse events of VGB for the treatment of infantile spasms, including VGB-related MRI abnormalities, visual abnormalities, and other adverse events.
Method:
MEDLINE, EMBASE, and Cochrane databases were searched. The population was infants treated with VGB for infantile spasms. The outcomes were VGB-related adverse events. Meta-analyses of VGB-related MRI abnormalities, retinal toxicity as measured by electroretinogram (ERG), visual field defects 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%), and for basal ganglia, brainstem, thalamic and dentate nuclei abnormalities were 21% (95% CI: 12–35%), 20% (95% CI: 15–27%), 16% (95% CI: 8–28%) and 14% (95% CI: 7–26%) respectively. Risk factors for MRI abnormalities included age less than 12 months, higher dose, and concomitant hormonal therapy. The MRI abnormalities were reversible in most patients. VGB-related retinal toxicity measured with ERG and visual field defect measured with perimetry occurred in 29% (95% CI: 7%–69%) and 28% (95%CI: 4–78%) respectively. Risk factor for retinal toxicity and visual field defect was longer duration of treatment. Higher cumulative dose increased the risk and severity of visual field defect. 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. There was no association between dose and VGB-related other adverse events.
Conclusion:
This study will inform physicians and families on the risk profile of VGB for the treatment of infantile spasms and will help decisions on treatment options.
Funding:
:None
Antiepileptic Drugs