Faculty mentor/PI email address
pittonrissardo-jamir@cooperhealth.edu
Keywords
Levetiracetam, antiseizure medication, irritability, aggression, agitation, side effect
Date of Presentation
5-6-2026 12:00 AM
Poster Abstract
Background: Levetiracetam is commonly used in epilepsy management but has been associated with irritability‑predominant aggressive behavioral adverse events, including irritability and aggression. Reported risks vary across trials, and the influence of comparator type and outcome definition remains unclear. We aimed to estimate the risk of irritability‑related aggressive behavioral adverse events associated with levetiracetam and to assess whether outcome definition or comparator subgroup modifies this risk. Methods: We searched ClinicalTrials.gov for interventional trials with posted results involving levetiracetam. Studies reporting irritability, aggression, agitation, or related irritability‑driven behaviors in comparisons with placebo or another antiseizure medication were included. Random‑effects Mantel–Haenszel meta‑analyses were conducted using risk ratios (RRs) with a continuity correction of 0.5 for zero‑event trials. Meta‑regression was performed to evaluate effect modification by outcome definition and comparator subgroup. Results: Thirty‑five trials were included (experimental = 2406, control = 2373). Overall, levetiracetam was associated with a non‑significant increase in irritability‑related aggressive behavioral adverse events compared with all comparators (RR = 1.37, 95% CI 0.97–1.95; Z = 1.78, p = 0.076), with no heterogeneity (χ² = 19.27, df = 34, p = 0.98; I² = 0%). In placebo‑controlled trials, effect estimates were directionally similar but not statistically significant (RR = 1.31, 95% CI 0.85–2.02). Meta‑regression demonstrated no significant moderation by outcome definition (irritability, agitation, aggression, or related terms) or by comparator subgroup relative to placebo (all p > 0.10), with negligible residual heterogeneity (τ² = 0). Conclusion: Across randomized trials with posted results, levetiracetam was not associated with a statistically significant increase in irritability‑centered aggressive behavioral adverse events compared with placebo or active comparators.
Disciplines
Medical Pharmacology | Medicine and Health Sciences
Included in
Irritability and Related Behavioral Adverse Events Associated With Levetiracetam: A Meta‑Analysis and Meta‑Regression of Randomized Trials
Background: Levetiracetam is commonly used in epilepsy management but has been associated with irritability‑predominant aggressive behavioral adverse events, including irritability and aggression. Reported risks vary across trials, and the influence of comparator type and outcome definition remains unclear. We aimed to estimate the risk of irritability‑related aggressive behavioral adverse events associated with levetiracetam and to assess whether outcome definition or comparator subgroup modifies this risk. Methods: We searched ClinicalTrials.gov for interventional trials with posted results involving levetiracetam. Studies reporting irritability, aggression, agitation, or related irritability‑driven behaviors in comparisons with placebo or another antiseizure medication were included. Random‑effects Mantel–Haenszel meta‑analyses were conducted using risk ratios (RRs) with a continuity correction of 0.5 for zero‑event trials. Meta‑regression was performed to evaluate effect modification by outcome definition and comparator subgroup. Results: Thirty‑five trials were included (experimental = 2406, control = 2373). Overall, levetiracetam was associated with a non‑significant increase in irritability‑related aggressive behavioral adverse events compared with all comparators (RR = 1.37, 95% CI 0.97–1.95; Z = 1.78, p = 0.076), with no heterogeneity (χ² = 19.27, df = 34, p = 0.98; I² = 0%). In placebo‑controlled trials, effect estimates were directionally similar but not statistically significant (RR = 1.31, 95% CI 0.85–2.02). Meta‑regression demonstrated no significant moderation by outcome definition (irritability, agitation, aggression, or related terms) or by comparator subgroup relative to placebo (all p > 0.10), with negligible residual heterogeneity (τ² = 0). Conclusion: Across randomized trials with posted results, levetiracetam was not associated with a statistically significant increase in irritability‑centered aggressive behavioral adverse events compared with placebo or active comparators.