Vigabatrin as initial therapy for infantile spasms: a European retrospective survey. Sabril IS Investigator and Peer Review Groups

Epilepsia. 1996 Jul;37(7):638-42. doi: 10.1111/j.1528-1157.1996.tb00627.x.


Purpose: The efficacy and tolerability of vigabatrin (VGB) as an add-on therapy in the treatment of infantile spasm (IS) prompted physicians to explore its use as the first drug in this seizure type.

Methods: Our retrospective study included 250 infants diagnosed with IS; the data obtained were subjected to peer-group review. Of this infant population, 192 infants were considered to have classic IS and had received VGB as their first treatment for the spasms. There was a slight preponderance of boys (57%) in this population. Mean age of IS onset was 5.8 months; 60% had typical hypsarrhythmia.

Results: Initial suppression of spasms was obtained in 68% of infants with a median time to response of 4 days at an average VGB dose of 99 mg/kg/day. The best response was seen in those infants with tuberous sclerosis (96% response) and in those younger than 3 months at onset of spasms (90% response). Of these infants, 43 (22%) of 192 subsequently had other types of seizures, and a recurrence of infantile spasms occurred in 28 (21%) of 131 responders. At the end of this study, 96 of 192 infants who could be evaluated were seizure free with VGB monotherapy. Treatment appeared to be well tolerated, with only 33 (13%) infants with adverse events, of which the most common were somnolence (15 patients) and hyperkinesia (eight patients). In only two cases did adverse events require VGB withdrawal.

Conclusion: This study supports the opinion that VGB may be considered an initial treatment for IS regardless of cause.

Publication types

  • Clinical Trial
  • Multicenter Study

MeSH terms

  • Age of Onset
  • Anticonvulsants / adverse effects
  • Anticonvulsants / therapeutic use*
  • Child, Preschool
  • Dose-Response Relationship, Drug
  • Drug Administration Schedule
  • Electroencephalography
  • Female
  • Humans
  • Infant
  • Male
  • Peer Review, Health Care
  • Retrospective Studies
  • Spasms, Infantile / drug therapy*
  • Treatment Outcome
  • Tuberous Sclerosis / drug therapy
  • Vigabatrin
  • gamma-Aminobutyric Acid / adverse effects
  • gamma-Aminobutyric Acid / analogs & derivatives*
  • gamma-Aminobutyric Acid / therapeutic use


  • Anticonvulsants
  • gamma-Aminobutyric Acid
  • Vigabatrin