Forty-two infants (22 males, 20 females) aged 2-9 months with newly diagnosed
infantile spasms, were included in the trial. Patients were randomized to receive VGB 100-150 mg/kg/day or Depot
ACTH 10 IU/day. The alternative
drug was given if
spasms were not controlled within 20 days or in cases of intolerance to initial
therapy. Twenty-three patients (7 cryptogenic, 16 symptomatic) received VGB as first-line
therapy; 19 patients (8 cryptogenic, 11 symptomatic) received
ACTH as the first
drug.
RESULTS: Cessation of
spasms was observed in 11 (48%) of the patients randomized to VGB and in 14 (74%) of those randomized to
ACTH. Response to VGB was observed within 1-14 days, but two-thirds of patients (7/11) responded within 3 days. In the group treated with VGB, side effects such as drowsiness,
hypotonia and irritability were observed in 13% of patients, compared with 37% in the group treated with
ACTH. VGB was more effective than
ACTH as treatment for cerebral malformations or
tuberous sclerosis, whereas
ACTH proved more effective in perinatal hypoxic/ischemic injury. The efficacy of the two drugs was similar in cryptogenic cases. Disappearance of interictal EEG abnormalities occurred sooner in patients randomized to
ACTH than in those who received VGB as initial
therapy. During the second phase, the alternative
drug was given to the resistant patients.
Spasms ceased in 2 of 5 patients treated with VGB and in 11 of 12 patients treated with
ACTH. After 3 months, relapses of
spasms were observed in 6 patients treated with
ACTH and in 1 treated with VGB. VGB produced a therapeutic response in nearly half the patients receiving this
drug.
CONCLUSIONS: