Infantile Spasms and Epilepsy Currents

Abstract

Listen

Translate article

The United Kingdom Infantile Spasms Study Comparing Vigabatrin with Prednisolone or Tetracosactide at 14 Days: A Multicentre, Randomised Controlled Trial Lux AL, Edwards SW, Hancock E, Johnson AL, Kennedy CR, Newton RW, O'Callaghan FJ, Verity CM, Osborne JP Lancet 2004;364:1773–1778 Purpose Infantile spasms, a severe infantile seizure disorder, have a high morbidity and are difficult to treat. Hormonal treatments (adrenocorticotropic hormone and prednisolone) have been the main therapy for decades, although little evidence supports their use. Vigabatrin has been recorded to have a beneficial effect in this disorder. We aimed to compare the effects of vigabatrin with those of prednisolone and tetracosactide in the treatment of infantile spasms. Methods The United Kingdom Infantile Spasms Study assessed these treatments in a multicenter, randomized controlled trial in 150 hospitals in the United Kingdom. The primary outcome was cessation of spasms on days 13 and 14. Minimum doses were vigabatrin, 100 mg/kg/day; oral prednisolone, 40 mg/day; or intramuscular tetracosactide depot, 0.5 mg (40 IU) on alternate days. Analysis was by intention to treat. Results Of 208 infants screened and assessed, 107 were randomly assigned to vigabatrin ( n = 52) or hormonal treatments (prednisolone, n = 30; tetracosactide, n = 25). None was lost to follow-up. Proportions with no spasms on days 13 and 14 were 40 (73%) of 55 infants assigned hormonal treatments (prednisolone, 21 of 30 [70%]; tetracosactide, 19 of 25 [76%]) and 28 (54%) of 52 infants assigned vigabatrin (difference, 19%; 95% CI, 1%–36%, p = 0.043). Two infants allocated tetracosactide and one allocated vigabatrin received prednisolone. Adverse events were reported in 30 (55%) of 55 infants receiving hormonal treatments and 28 (54%) of 52 infants receiving vigabatrin. No deaths were recorded. Conclusions Cessation of spasms was more likely in infants given hormonal treatments than in those given vigabatrin. Adverse events were common with both treatments.