title: The United Kingdom Infantile Spasms Study (UKISS) comparing hormone treatment with vigabatrin on developmental and epilepsy outcomes to age 14 months: a multicentre randomised trial.
abstract: BACKGROUND
  Infantile spasms is a severe infantile seizure disorder that is difficult to treat and has a high morbidity. Absence of spasms on days 13 and 14 after randomisation is more common in infants allocated hormone treatments than in those allocated vigabatrin. We sought to assess whether early control of spasms is associated with improved developmental or epilepsy outcomes.
  
  
  METHODS
  Infants enrolled in the United Kingdom Infantile Spasms Study (UKISS) were randomly assigned hormone treatment (n=55) or vigabatrin (n=52) and were followed up until clinical assessment at 12-14 months of age. We assessed neurodevelopment with the Vineland adaptive behaviour scales (VABS) at 14 months of age on an intention to treat basis.
  
  
  RESULTS
  Of 107 infants enrolled, five died and 101 survivors reached both follow-up assessments. Absence of spasms at final clinical assessment (hormone 41/55 [75%] vs vigabatrin 39/51 [76%]) was similar in each treatment group (difference 1.9%, 95% CI -18.3% to 14.4%; chi(2)=0.05; p=0.82). Mean VABS score did not differ significantly (hormone 78.6 [SD 16.8] vs vigabatrin 77.5 [SD 12.7]; difference 1.0, 95% CI -4.9 to 7.0; t(99)=0.35, p=0.73). In infants with no identified underlying aetiology, the mean VABS score was higher in those allocated hormone treatment than in those allocated vigabatrin (88.2 [17.3] vs 78.9 [14.3]; difference 9.3, 95% CI 1.2 to 17.3; t(95)=2.28, p=0.025).
  
  
  CONCLUSIONS
  Hormone treatment controls spasms better than does vigabatrin initially, but not at 12-14 months of age. Better initial control of spasms by hormone treatment in those with no identified underlying aetiology may lead to improved developmental outcome.
authors.affiliation: Royal United Hospital Bath NHS Trust and the School for Health, University of Bath, Bath, UK.
authors.forename: Andrew L
authors.initials: AL
authors.lastname: Lux
authors.forename: Stuart W
authors.initials: SW
authors.lastname: Edwards
authors.forename: Eleanor
authors.initials: E
authors.lastname: Hancock
authors.forename: Anthony L
authors.initials: AL
authors.lastname: Johnson
authors.forename: Colin R
authors.initials: CR
authors.lastname: Kennedy
authors.forename: Richard W
authors.initials: RW
authors.lastname: Newton
authors.forename: Finbar J K
authors.initials: FJ
authors.lastname: O'Callaghan
authors.forename: Christopher M
authors.initials: CM
authors.lastname: Verity
authors.forename: John P
authors.initials: JP
authors.lastname: Osborne
mesh_terms: D000223:Adaptation, Psychological / Q000502:physiology; D000893:Anti-Inflammatory Agents / Q000627:therapeutic use*; D000927:Anticonvulsants / Q000009:adverse effects / Q000627:therapeutic use*; D002657:Child Development; D003366:Cosyntropin / Q000627:therapeutic use*; D018450:Disease Progression; D004827:Epilepsy / Q000188:drug therapy* / Q000453:epidemiology; D005260:Female; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D008297:Male; D011239:Prednisolone / Q000627:therapeutic use*; D055502:Secondary Prevention; D013036:Spasms, Infantile / Q000188:drug therapy* / Q000453:epidemiology; D016896:Treatment Outcome; D006113:United Kingdom / Q000453:epidemiology; D020888:Vigabatrin / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D000893:Anti-Inflammatory Agents; D000927:Anticonvulsants; D003366:Cosyntropin; D011239:Prednisolone; D020888:Vigabatrin