High-dose prednisone therapy for infantile spasms and late-onset epileptic spasms in China: The addition of topiramate provides no benefit.

PURPOSE

To compare the clinical efficacy of high-dose prednisone monotherapy and the combination of hormone and moderate-dose topiramate (TPM) therapy in children with infantile spasms (IS) and late-onset epileptic spasms (ES), and to evaluate whether the addition of TPM would provide more benefits for patients.

METHODS

All patients were assigned to receive either high-dose prednisone alone (the maximum doses was 60 mg a day) or high-dose prednisone with TPM (the moderate doses was 5 mg/kg/day). The primary outcome was the proportion of children who achieved cessation of spasms at day-49 or day-56 after initial treatment (the minimum duration of treatment were 49 days).

RESULTS

77 patients were randomly divided into two groups. The control rate of spasms on day-14 in hormone monotherapy was similar to combination therapy (71.8% vs 76.3%, p = 0.796). The cessation of spasms rate of patients on day-49 or day-56 was also similar between the two groups (71.8% vs 65.8%, p = 0.569). After 4 months, the cessation of spasms rate of patients in the group of hormone monotherapy was higher than the group of combination therapy, but there was no significant difference (61.5% vs 50.0%, p = 0.308).

CONCLUSION

The efficacy of the combination therapy was not better than that of the monotherapy in achieving spasm freedom at 14-days, 49-days or 56-days and day-120 in the patients. Adding-on moderate-dose TPM did not help more children achieve spasm freedom and provided no benefit for prevention of IS and late-onset ES in short term. Higher-dose regimens of TPM might be more effective.