The United Kingdom Infantile Spasms Study comparing vigabatrin with prednisolone or tetracosactide at 14 days: a multicentre, randomised controlled trial

Recent Advances in the Pharmacotherapy of Infantile Spasms

“…There are no studies comparing the effects of natural ACTH and synthetic derivates in the treatment of infantile spasms. Doses of ACTH vary in different countries: Japan, 0.1 mg/day [20]; Finland, 0.25 mg/day (=0.5 mg every second day) [21]; UK, 0.5 mg every second day [22]; and US 60-80 IU/day (=0.6-0.8 mg/day) [23]. It is not clear why infants in the US would need considerably larger doses than in Japan.…”

“…In the largest open randomised prospective study (the United Kingdom Infantile Spasms Study; UKISS) including 107 children (excluding TS), the effects (cessation of the spasms) of ACTH and vigabatrin were 76 % and 52 % at day 14 of treatment, respectively (p \ 0.043) [22] (Class III). Relapse rates did not differ significantly between the treatment groups.…”

“…Results from two Class III studies (N = 107 and 28, respectively) indicate that hormonal therapy leads to resolution of spasms three times more rapidly and in more infants than vigabatrin [22,39].…”

“…After pooling the data of eight separate prospective and retrospective studies, vigabatrin had a good response on spasms in 44 % of 478 patients [11,22,31,39,40,[45][46][47]. In the pooled data of nine separate prospective and retrospective studies, ACTH had a good response on spasms in 59 % of 476 patients [22, 24, 26-29, 34, 48, 49].…”

“…Large doses of prednisolone (40-60 mg/day) have recently been given with high response rates of 21/30 (70 %) [22], 51/72 (70 %) [58], 28/57 (49 %) [59] and 10/15 (66 %) [60]. The studies were not been evidencebased studies except for one [22]. However, oral prednisolone is a promising and much less expensive alternative to intramuscular ACTH and that is why it is used in developing countries.…”