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Objectives <p>To compare the efficacy of sodium valproate (VPA) and levetiracetam (LEV) as initial maintenance monotherapy in children with new-onset epilepsy.</p> Methods <p>This randomised controlled trial was conducted in tertiary pediatric epilepsy and neurology clinics. Children 2–18 y with new-onset epilepsy were enrolled as participants. Patients were prescribed VPA (<i>n</i> = 58) or LEV (<i>n</i> = 58) at 20&#xa0;mg/kg/d in two doses with increments of 20&#xa0;mg/kg/d to a maximum of 60&#xa0;mg/kg/d (Maximum daily dose: VPA 2&#xa0;g/d and LEV 3&#xa0;g/d). Primary outcome was the proportion of patients who achieved seizure control for three consecutive months. Secondary outcomes included the proportion of patients who achieved a 50% reduction in seizures from baseline and those who developed side-effects.</p> Results <p>A total of 116 patients were analysed using intention-to-treat analysis. There was no difference in the primary outcome between LEV vs. VPA groups [58.6% vs. 65.5%; relative risk (RR) 0.89 (95% CI, 0.67–1.19), <i>p</i> = 0.444]. There was no difference in patients who achieved a 50% seizure reduction from baseline between the two groups (70.7% vs. 70.7%) and side-effect profile (32.8% vs. 46.6%, <i>p</i> = 0.128) other than median (IQR) weight gain (kg), which was significantly lower in the LEV group (1.35, 0.70–1.60) as compared to the VPA group (2.15, 1.40–2.60) (<i>p</i> &lt; 0.001). One patient in the VPA group had Stevens-Johnson syndrome. No mortality occurred.</p> Conclusions <p>No difference was noted between sodium valproate and levetiracetam in seizure control. With a favorable side-effect profile, levetiracetam can be safely considered as initial maintenance monotherapy in children with new-onset epilepsy.</p>

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Randomised Controlled Trial on Sodium Valproate and Levetiracetam in Children with New-Onset Epilepsy

  • 期刊论文

  • 发表日期：

    2026年1月23日

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  • Kalyana Prabhakaran,
  • Ramachandran Rameshkumar,
  • Niranjan Biswal,
  • Pradeep P. Nair,
  • K T Harichandrakumar

摘要

Objectives

To compare the efficacy of sodium valproate (VPA) and levetiracetam (LEV) as initial maintenance monotherapy in children with new-onset epilepsy.

Methods

This randomised controlled trial was conducted in tertiary pediatric epilepsy and neurology clinics. Children 2–18 y with new-onset epilepsy were enrolled as participants. Patients were prescribed VPA (n = 58) or LEV (n = 58) at 20 mg/kg/d in two doses with increments of 20 mg/kg/d to a maximum of 60 mg/kg/d (Maximum daily dose: VPA 2 g/d and LEV 3 g/d). Primary outcome was the proportion of patients who achieved seizure control for three consecutive months. Secondary outcomes included the proportion of patients who achieved a 50% reduction in seizures from baseline and those who developed side-effects.

Results

A total of 116 patients were analysed using intention-to-treat analysis. There was no difference in the primary outcome between LEV vs. VPA groups [58.6% vs. 65.5%; relative risk (RR) 0.89 (95% CI, 0.67–1.19), p = 0.444]. There was no difference in patients who achieved a 50% seizure reduction from baseline between the two groups (70.7% vs. 70.7%) and side-effect profile (32.8% vs. 46.6%, p = 0.128) other than median (IQR) weight gain (kg), which was significantly lower in the LEV group (1.35, 0.70–1.60) as compared to the VPA group (2.15, 1.40–2.60) (p < 0.001). One patient in the VPA group had Stevens-Johnson syndrome. No mortality occurred.

Conclusions

No difference was noted between sodium valproate and levetiracetam in seizure control. With a favorable side-effect profile, levetiracetam can be safely considered as initial maintenance monotherapy in children with new-onset epilepsy.