The first-line use of vigabatrin to achieve complete control of infantile spasms

Practice Parameter: Medical Treatment of Infantile Spasms

“…Only those prospective studies of children with tuberous sclerosis and infantile spasms who were evaluated under 3 years of age were included. 19,32,33,35,36,38,42 The response of the infantile spasms to vigabatrin in infants with tuberous sclerosis was uniformly good, with a high percentage of responders whose spasms remitted. Overall cessation of spasms was seen in 41 of 45 (91%) of children treated with vigabatrin, with a 100% response rate seen in five studies.…”

“…Fourteen studies met the inclusion criteria for analysis: one randomized placebo controlled study providing class I evidence, 31 two randomized controlled studies providing class III evidence, 19,32 six prospective uncontrolled open-label trials, [33][34][35][36][37][38] and five retrospective case series, 25,[39][40][41][42] providing class IV evidence (table 4). Age at onset ranged from 1 week to 18 months, and age at treatment ranged from 2 to 28 months.…”

“…19,31,32 In the six class IV open-label uncontrolled prospective studies (n ϭ 6 to 116 patients), the response rate ranged from 0 to 59% for children with symptomatic infantile spasms and from 50 to 100% for cryptogenic infantile spasms; children with cryptogenic infantile spasms had a higher response rate to vigabatrin than those with symptomatic spasms across all prospective studies. [33][34][35][36][37][38] In the nine prospective studies reviewed, vigabatrin dosages ranged from 18 to 200 mg/kg/day. The numbers were not large enough to determine if the efficacy of vigabatrin in infantile spasms was dose dependent.…”

“…Overall cessation of spasms was seen in 41 of 45 (91%) of children treated with vigabatrin, with a 100% response rate seen in five studies. 19,32,35,36,38 What are the side effects of vigabatrin? Evidence.…”

“…19,31,32 There were two deaths unrelated to vigabatrin and one death in which the cause was not known across the three studies. 19,32 In the six class IV open-label uncontrolled prospective studies, sedation was noted in 14 to 16% of patients, 33,35,37 irritability in 13 to 33%, [33][34][35][36] and hypotonia in 33%. 34 None of the patients discontinued treatment, and there were no reported deaths in 244 patients across six studies.…”