Author:
Baram Tallie Z.,Mitchell Wendy C.,Tournay Anne,Snead O. Carter,Hanson Rebecca A.,Horton E. J.
Abstract
Objective. To compare the efficacy of corticotropin (ACTH) (150 U/m2/day) and prednisone (2 mg/kg/day), given for 2 weeks, in suppressing clinical spasms and hypsarrhythmic electroencephalogram (EEG) in infantile spasms (IS). ACTH and prednisone are standard treatments for IS. ACTH at high doses causes severe dose- and duration-dependent side effects, but may be superior to prednisone, based on retrospective or uncontrolled studies. Blinded prospective studies have shown equal efficacy of prednisone and low-dose ACTH, and low versus high-dose ACTH.
Design. A prospective, randomized, single-blinded study.
Subjects and Methods. Patient population consisted of consecutive infants fulfilling entry criteria, including the presence of clinical spasms, hypsarrhythmia (or variants) during a full sleep cycle video-EEG, and no prior steroid/ACTH treatment. Response required both cessation of spasms and elimination of hypsarrhythmia by the end of the 2-week treatment period, as determined by an investigator "blinded" to treatment. Treatment of responders was tapered off over 12 days; those failing one hormone were crossed-over to the other.
Results. Of 34 eligible infants, 29 were enrolled. Median age of patients was 6 months. Twenty-two infants were "symptomatic" with known or suspected cause, and seven were cryptogenic (two normal). Of 15 infants randomized to ACTH, 13 responded by both EEG and clinical criteria (86.6%); seizures stopped in an additional infant, but EEG remained hypsarrhythmic (considered a failure). Four of 14 patients given prednisone responded (28.6%, with complete clinical-EEG correlation), significantly less than with ACTH, (x2 test).
Conclusions. Using a prospective, randomized approach, a 2-week course of high-dose ACTH is superior to 2 weeks of prednisone for treatment of IS, as assessed by both clinical and EEG criteria.
Publisher
American Academy of Pediatrics (AAP)
Subject
Pediatrics, Perinatology and Child Health
Cited by
39 articles.
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