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Safety of Levetiracetam in Paediatrics: A Systematic Review
Oluwaseun Egunsola1, Imti Choonara1, Helen Mary Sammons1
1Division of Medical Sciences and Graduate Entry Medicine, School of Medicine, University of Nottingham, Royal Derby Hospital, Derby, DE22 3DT, United Kingdom.
Insights
Levetiracetam (LEV) in children commonly causes behavioral issues and somnolence. Pediatric patients on polytherapy face higher risks of adverse events and discontinuation compared to monotherapy.
Area of Science:
- Pediatric Neurology
- Pharmacovigilance
- Epilepsy Treatment
Background:
- Levetiracetam (LEV) is a widely used antiepileptic drug.
- Understanding its adverse events (AEs) in children is crucial for safe and effective treatment.
Purpose of the Study:
- To systematically identify and analyze adverse events (AEs) associated with Levetiracetam (LEV) in pediatric epilepsy patients.
- To compare the incidence of AEs and treatment discontinuation between LEV monotherapy and polytherapy regimens.
Main Methods:
- A comprehensive literature search of EMBASE and Medline databases was conducted for studies on pediatric LEV use (≤18 years) for epilepsy.
- Included studies reported safety data; excluded studies with insufficient pediatric data or adult-only populations.
- Meta-analysis of randomized controlled trials (RCTs) was performed, with Chi-squared analysis to assess associations between AEs/discontinuation and therapy type (monotherapy vs. polytherapy).
Main Results:
- Sixty-seven articles involving 3,174 pediatric patients were reviewed, reporting 1,913 AEs.
- The most frequent AEs were behavioral problems (10.9%) and somnolence (8.4%).
- Children on polytherapy experienced significantly more AEs (64%) versus monotherapy (22%) and had higher discontinuation rates (4.5% vs. 0.9%), primarily due to behavioral issues.
Conclusions:
- Behavioral problems and somnolence are the most common adverse events associated with Levetiracetam in children.
- Pediatric patients receiving Levetiracetam as part of polytherapy exhibit an increased risk of adverse events and treatment discontinuation compared to those on monotherapy.
Objective:
To identify adverse events (AEs) associated with Levetiracetam (LEV) in children.
Methods:
Databases EMBASE (1974-February 2015) and Medline (1946-February 2015) were searched for articles in which paediatric patients (≤18 years) received LEV treatment for epilepsy. All studies with reports on safety were included. Studies involving adults, mixed age population (i.e. children and adults) in which the paediatric subpopulation was not sufficiently described, were excluded. A meta-analysis of the RCTs was carried out and association between the commonly reported AEs or treatment discontinuation and the type of regimen (polytherapy or monotherapy) was determined using Chi2 analysis.
Results:
Sixty seven articles involving 3,174 paediatric patients were identified. A total of 1,913 AEs were reported across studies. The most common AEs were behavioural problems and somnolence, which accounted for 10.9% and 8.4% of all AEs in prospective studies. 21 prospective studies involving 1120 children stated the number of children experiencing AEs. 47% of these children experienced AEs. Significantly more children experienced AEs with polytherapy (64%) than monotherapy (22%) (p<0.001). Levetiracetam was discontinued in 4.5% of all children on polytherapy and 0.9% on monotherapy (p<0.001), the majority were due to behavioural problems.
Conclusion:
Behavioural problems and somnolence were the most prevalent adverse events to LEV and the most common causes of treatment discontinuation. Children on polytherapy have a greater risk of adverse events than those receiving monotherapy.
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