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Infantile spasms are usually treated with either steroid (oral corticosteroid or intramuscular adrenocorticotropic hormone) or vigabatrin. These treatments have been compared in a UK multicentre trial (
A total of 107 infants aged 2–12 months with infantile spasms (not due to tuberous sclerosis) were randomised (2:1:1) at 150 centres to vigabatrin, prednisolone, or tetracosactide. Vigabatrin dosage was 25 mg/kg twice on day 1 and 50 mg/kg twice daily from day 2, increasing to 75 mg/kg twice daily from day 5 if spasms persisted. Prednisolone dosage was 10 mg four times daily, increasing if spasms persisted to 20 mg three times daily in the second week. Tetracosactide was given intramuscularly in a dose of 0.5 mg (40 IU) on alternate days, increasing if spasms persisted to 0.75 mg on alternate days in the second week. Each of the steroid groups received treatment for 2 weeks after which a tailing dose of prednisolone was given over a period of 15 days. Infants with tuberous sclerosis were excluded because of evidence that they are best treated with vigabatrin.
Treatment success (no spasms on days 13 and 14) was achieved for 28/52 (54%) in the vigabatrin group, 21/30 (70%) in the prednisolone group, and 19/25 (76%) in the tetracosactide group—a significant difference between the vigabatrin and the steroid groups. There was no significant difference between the two steroid groups. Of the 107 EEGs 83 (78%) showed hypsarrhythmia and 21 “almost hypsarrhythmia”. Spasms stopped in 53/83 (64%) with hypsarrhythmia and 15/24 (63%) without hypsarrhythmia. Hypsarrhythmia resolved significantly more often with steroid treatment (26/32, 81%) than with vigabatrin (20/36, 56%). The rates of treatment success were similar in symptomatic and cryptogenic infantile spasms. The incidence of adverse events was similar in the steroid and vigabatrin groups. Irritability was more common with steroid treatment and drowsiness with vigabatrin. Five of the 55 infants in the steroid groups developed fluid and electrolyte problems including high blood pressure.
Steroid treatment (prednisolone or tetracosactide) was more likely than vigabatrin to result in cessation of spasms and more likely to induce resolution of hypsarrhythmia. The long term results of the trial are to be reported.