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Amelioration of Levetiracetam-Induced Behavioral Side Effects by Pyridoxine. A Randomized Double Blind Controlled
Adel Mahmoud1, Sadia Tabassum1, Shoaa Al Enazi1
1Department of Pediatric Neurology, National Neuroscience Institute, King Fahad Medical City, Riyadh, Kingdom of Saudi Arabia.
Insights
Pyridoxine supplementation may help reduce neuropsychiatric side effects in children treated with levetiracetam, an antiseizure medication. This study found therapeutic doses of pyridoxine more effective than placebo in improving behavioral symptoms.
Area of Science:
- Neurology
- Pediatric Epilepsy
- Pharmacology
Background:
- Levetiracetam is a widely used antiseizure drug for focal and generalized seizures.
- Neuropsychiatric side effects occur in up to 13% of pediatric patients on levetiracetam.
- Controlled trials investigating pyridoxine's efficacy in mitigating these side effects are lacking.
Purpose of the Study:
- To evaluate the effectiveness of pyridoxine in attenuating neuropsychiatric side effects associated with levetiracetam in children.
- To provide evidence-based information for clinicians managing levetiracetam-induced behavioral changes.
Main Methods:
- A randomized, double-blind, placebo-controlled trial was conducted.
- 105 children experiencing behavioral symptoms with levetiracetam were randomized to receive either therapeutic pyridoxine or a placebo.
- Behavioral side effects were assessed using a 30-item checklist at baseline and follow-up points.
Main Results:
- Both pyridoxine and placebo groups showed a statistically significant reduction in behavioral scores from baseline.
- The improvement in neuropsychiatric symptoms was more pronounced in the group receiving therapeutic doses of pyridoxine.
- A placebo effect was observed, but pyridoxine demonstrated a more prominent beneficial impact.
Conclusions:
- Pyridoxine supplementation may be a viable option for managing levetiracetam-induced neuropsychiatric side effects in children.
- Clinicians can consider a trial of pyridoxine to potentially avoid switching antiseizure medications.
- This study provides evidence supporting pyridoxine's role in pediatric epilepsy management.
Background:
Levetiracetam is a relatively new-generation antiseizure drug approved for the treatment of focal and generalized seizures. Despite its favorable side effect profile and minimal drug-drug interactions, neuropsychiatric side effects are reported in up to 13% of children. A few case series have suggested that supplementation of pyridoxine may mitigate these side effects, but controlled trials are lacking. To address this issue, a randomized interventional study was carried out in a pediatric tertiary hospital to qualify and quantify the potential beneficial effect of pyridoxine in attenuating the neuropsychiatric side effects of levetiracetam in children.
Methods:
A total of 105 children with epilepsy who were taking levetiracetam (as a monotherapy or an adjunct) who showed behavioral symptoms coinciding with the start of levetiracetam, were included. Patients randomly and blindly received either a therapeutic (pyridoxine group, 46 of 105, 44%) or a homeopathic dose of pyridoxine (placebo, 59 of 105, 56%). A 30-item behavioral checklist was used to qualify and quantify the behavioral side effects at baseline and at different time points following initiation of treatment.
Results:
Both placebo and pyridoxine groups experienced a statistical reduction in behavioral scores when compared with baseline. Our study indicated that although there was a placebo effect, the improvement in neuropsychiatric symptoms was more prominent in children who received therapeutic doses of pyridoxine.
Conclusions:
These data provide clinicians with pertinent evidence-based information that suggests that a trial of pyridoxine in patients who experience behavioral side effects due to the use of levetiracetam may avoid unnecessary change of antiseizure medications.
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