Intravenous Methylprednisolone Versus Oral Prednisolone for West Syndrome: A Randomized Open-Label Trial

Dipti Kapoor, Suvasini Sharma, Divyani Garg, Sukla Samaddar, Isha Panda, Bijoy Patra, Sharmila B Mukherjee, Harish K Pemde, Dipti Kapoor, Suvasini Sharma, Divyani Garg, Sukla Samaddar, Isha Panda, Bijoy Patra, Sharmila B Mukherjee, Harish K Pemde

Abstract

Objective: To compare intravenous methylprednisolone (IVMP) with oral prednisolone (OP) for the treatment of West syndrome.

Methods: In this randomized, open-label trial, children aged 2 to 30 mo presenting with epileptic spasms with hypsarrhythmia or its variants on EEG were randomized to receive either IVMP (30 mg/kg/d for 3 d followed by oral prednisolone taper) or OP (4 mg/kg/d for two weeks followed by taper). The primary outcome measure was spasms cessation on day 14. Secondary outcomes included time to response, electroclinical remission at 2 and 6 wk, and frequency of adverse effects. ( ClinicalTrials.gov Identifier: NCT03876444).

Results: Sixty children were enrolled; 31 in the IVMP and 29 in the OP arm. Proportion of children achieving spasms cessation at day 14 was similar in both groups (54.8% versus 68.9%, p = 0.26). Time to achieve remission was lower in the IVMP group (mean 5.4 ± 0.9 versus 9.5 ± 2.6 d, p < 0.0001). Electroclinical remission at 2 wk was similar in both groups (51.6% versus 44.8%, p = 0.59) but lower at 6 wk in the IVMP group (45.2% versus 75.9%, p < 0.015). Adverse effects like sleep disturbance, irritability and hypertension were more common in IVMP group whereas weight gain was more common in the OP group.

Conclusions: There was no significant difference in spasms cessation between the groups on day 14 although remission was higher at 6 wk in OP group. Our study suggests that OP was better than IVMP in efficacy and sustained remission with fewer adverse effects.

Keywords: ACTH; Epileptic spasms; Hormonal therapy; Hypsarrhythmia; Infantile spasms.

Conflict of interest statement

None.

© 2020. Dr. K C Chaudhuri Foundation.

Figures

Fig. 1
Fig. 1
Flow of patients in the study

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Source: PubMed

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