title: Vigabatrin for the treatment of infantile spasms: final report of a randomized trial.
abstract: A large randomized study was conducted in patients with newly diagnosed infantile spasms to compare 2 doses of vigabatrin in achieving spasm cessation. High (100-148 mg/kg/d) and low (18-36 mg/kg/d) oral doses of vigabatrin were evaluated in a randomized, single-blind study of 14 to 21 days with subsequent open-label treatment up to 3 years. Spasm cessation was defined as 7 consecutive days of spasm freedom beginning within the first 14 days, confirmed by video-electroencephalogram. A total of 221 subjects comprised the modified intent-to-treat cohort. More subjects in the high-dose group achieved spasm cessation compared with the low-dose vigabatrin group (15.9% [17/107] vs 7.0% [8/114]; P = .0375). During follow-up, 39 of 171 (23%) subjects relapsed; 28 of 39 (72%) regained spasm freedom. Adverse events were primarily mild to moderate in severity. Vigabatrin had a dose-dependent effect in spasm reduction. Spasm cessation occurred rapidly and was maintained in the majority of infants.
authors.affiliation: Dallas Pediatric Neurology Associates, Medical City Dallas Hospital, Dallas, TX 75230-2507, USA. roydelterman@aol.com
authors.forename: Roy D
authors.initials: RD
authors.lastname: Elterman
authors.forename: W Donald
authors.initials: WD
authors.lastname: Shields
authors.forename: Richard M
authors.initials: RM
authors.lastname: Bittman
authors.forename: Sarah A
authors.initials: SA
authors.lastname: Torri
authors.forename: Stephen M
authors.initials: SM
authors.lastname: Sagar
authors.forename: Stephen D
authors.initials: SD
authors.lastname: Collins
mesh_terms: D000927:Anticonvulsants / Q000627:therapeutic use; D016009:Chi-Square Distribution; D002675:Child, Preschool; D004569:Electroencephalography; D005260:Female; D006801:Humans; D007223:Infant; D057194:Intention to Treat Analysis; D053208:Kaplan-Meier Estimate; D008297:Male; D016037:Single-Blind Method; D013036:Spasms, Infantile / Q000175:diagnosis / Q000188:drug therapy*; D016896:Treatment Outcome; D020888:Vigabatrin / Q000627:therapeutic use*
chemical_list: D000927:Anticonvulsants; D020888:Vigabatrin