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Combination Therapy With Vigabatrin and Prednisolone Versus Vigabatrin Alone for Infantile Spasms
Rachata Boonkrongsak1,2, Kantapon Trongkamolchai1, Sirorat Suwannachote1,2
1Division of Neurology, Department of Pediatrics, Queen Sirikit National Institute of Child Health, Ministry of Public Health, Bangkok, Thailand.
Insights
Combination therapy with vigabatrin and prednisolone significantly improved spasm remission in infants with infantile epileptic spasms syndrome (IESS). This treatment demonstrated higher effectiveness compared to vigabatrin alone, offering a promising therapeutic option.
Area of Science:
- Pediatric Neurology
- Clinical Pharmacology
- Epileptology
Background:
- Infantile epileptic spasms syndrome (IESS) is a severe form of epilepsy in infants.
- Early diagnosis and effective treatment are crucial for improving outcomes.
- Vigabatrin is a standard treatment, but combination therapies are being explored.
Purpose of the Study:
- To evaluate the efficacy of combination therapy (vigabatrin and prednisolone) versus vigabatrin monotherapy for IESS.
- To determine the rate of sustained spasm remission and electroclinical response.
Main Methods:
- A single-center, single-blind, randomized trial (NCT04302116) involving infants aged 2-14 months with new-onset IESS.
- Participants were randomized (1:1) to receive either combination therapy or vigabatrin alone.
- The primary outcome was sustained spasm remission between days 14 and 42; the trial was terminated early due to interim analysis findings.
Main Results:
- Combination therapy led to sustained spasm remission in 77% of infants versus 33% in the vigabatrin-only group (OR 6.5, p=0.009).
- An electroclinical response by day 14 was significantly higher with combination therapy (OR 9.3, p=0.006).
- Hospitalization rates were higher in the combination therapy group (35% vs 8%).
Conclusions:
- Combination therapy with vigabatrin and prednisolone is significantly more effective for achieving clinical remission of spasms in IESS.
- Early electroclinical response is enhanced with combination therapy.
- Further research may be warranted to balance efficacy and potential side effects.
Objective:
The study evaluated the effectiveness of combination therapy with vigabatrin and prednisolone versus vigabatrin alone for treating infantile epileptic spasms syndrome (IESS).
Methods:
This single-center, single-blind, randomized trial enrolled infants aged 2-14 months with new-onset IESS, randomly assigned them (1:1) to receive either combination therapy with vigabatrin (100-150 mg/kg/day) and prednisolone (40-60 mg/day) or vigabatrin alone. The primary outcome was sustained spasm remission between days 14 and 42. The trial (ClinicalTrials.gov identifier) was terminated early due to an interim analysis revealing a significant difference between treatment groups.
Results:
In all, 17 infants were assigned to combination therapy and 24 to vigabatrin alone. The median lead time to treatment for combination therapy was 30 days, compared to 60 days for the vigabatrin group (p = 0.442). Sustained spasm remission between days 14 and 42 occurred in 13 (77%) of 17 infants on combination therapy and in 8 (33%) of 24 infants on vigabatrin alone (OR 6.5, 95% CI 1.7, 29.6, p = 0.009). Combination therapy was more effective in achieving an electroclinical response by day 14 (OR 9.3, 95% CI 2.0, 54.3, p = 0.006) but not by day 42 (OR 1.9, 95% CI 0.5, 7.1, p = 0.351). Hospitalization occurred in six (35%) infants in the combination therapy group and two (8%) in the vigabatrin alone group (p = 0.05). One death was reported in the vigabatrin group.
Interpretation:
Despite early termination, this study showed that combination therapy is significantly more effective in achieving clinical remission of spasms and an electroclinical response by day 14.
Trial Registration:
NCT04302116.
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