PURPOSE: A prospective study was conducted for the purpose of identifying the efficacy and safety of a protocol, first-line topiramate (TPM) followed by low-dose adrenocorticotropic hormone (ACTH) as the second drug, in the treatment of infantile spasms. METHODS: 40 children newly diagnosed with infantile spasms between 2007 and 2008 were enrolled in this study. They received an initial dose of 0.5-1mg/kg/day TPM, with 0.5-1mg/kg/day ascending every 3-7 days up to the target dose within the first 1 month. Partial/nonresponders for TPM were subsequently added low-dose and short-duration ACTH as the second treatment. Both efficiency and side effects were evaluated during the follow-up period. RESULTS: Infants became spasms-free in 27 (67.5%) of all patients comprising 10 patients treated with TPM monotherapy and 17 with the combination of TPM and ACTH. Greater than 75% reduction in the frequency of spasms was found in 4 of all patients and at least 50% reduction in 4 patents as well. Side effects occurred in 29 (72.5%) patients; apart from 6 patients who needed moderately medical intervention, side effects throughout the trial were mild and well tolerated. CONCLUSIONS: This prospective study demonstrated that, on the basis of primary TPM therapy, the combination treatment both TPM and low-dose ACTH was effective and available for the patients with infantile spasms.
PURPOSE: A prospective study was conducted for the purpose of identifying the efficacy and safety of a protocol, first-line topiramate (TPM) followed by low-dose adrenocorticotropic hormone (ACTH) as the second drug, in the treatment of infantile spasms. METHODS: 40 children newly diagnosed with infantile spasms between 2007 and 2008 were enrolled in this study. They received an initial dose of 0.5-1mg/kg/day TPM, with 0.5-1mg/kg/day ascending every 3-7 days up to the target dose within the first 1 month. Partial/nonresponders for TPM were subsequently added low-dose and short-duration ACTH as the second treatment. Both efficiency and side effects were evaluated during the follow-up period. RESULTS:Infants became spasms-free in 27 (67.5%) of all patients comprising 10 patients treated with TPM monotherapy and 17 with the combination of TPM and ACTH. Greater than 75% reduction in the frequency of spasms was found in 4 of all patients and at least 50% reduction in 4 patents as well. Side effects occurred in 29 (72.5%) patients; apart from 6 patients who needed moderately medical intervention, side effects throughout the trial were mild and well tolerated. CONCLUSIONS: This prospective study demonstrated that, on the basis of primary TPM therapy, the combination treatment both TPM and low-dose ACTH was effective and available for the patients with infantile spasms.