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Intravenous Methylprednisolone Versus Oral Prednisolone for West Syndrome: A Randomized Open-Label Trial
Dipti Kapoor1, Suvasini Sharma2, Divyani Garg3
1Division of Neurology, Department of Pediatrics, Kalawati Saran Children's Hospital and Lady Hardinge Medical College, New Delhi, 110001, India.
Insights
Oral prednisolone (OP) demonstrated better efficacy and sustained remission for West syndrome compared to intravenous methylprednisolone (IVMP), with fewer adverse effects observed in the OP group.
Area of Science:
- Pediatric Neurology
- Clinical Pharmacology
Background:
- West syndrome is a severe form of epilepsy in infants.
- Early diagnosis and effective treatment are crucial for long-term outcomes.
- Corticosteroids are a primary treatment modality for West syndrome.
Purpose of the Study:
- To compare the efficacy and safety of intravenous methylprednisolone (IVMP) versus oral prednisolone (OP) in treating West syndrome.
- To evaluate short-term and long-term remission rates and adverse effects of both treatment regimens.
Main Methods:
- A randomized, open-label trial involving children aged 2-30 months with West syndrome.
- Participants received either IVMP (30 mg/kg/d for 3 days) or OP (4 mg/kg/d for two weeks), both followed by a tapering schedule.
- Primary outcome was spasms cessation at day 14; secondary outcomes included time to response, electroclinical remission at 2 and 6 weeks, and adverse events.
Main Results:
- Spasms cessation at day 14 was similar between IVMP and OP groups (54.8% vs. 68.9%).
- Time to remission was significantly shorter with IVMP (5.4 days) compared to OP (9.5 days).
- Electroclinical remission at 6 weeks was higher in the OP group (75.9%) than the IVMP group (45.2%). Adverse effects differed, with IVMP associated with sleep disturbance and irritability, and OP with weight gain.
Conclusions:
- Oral prednisolone (OP) showed superior efficacy in achieving sustained electroclinical remission at 6 weeks for West syndrome compared to IVMP.
- OP was associated with fewer adverse effects than IVMP, suggesting it may be a preferred treatment option.
- While IVMP offered faster initial remission, OP provided better long-term outcomes and a more favorable safety profile.
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.
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