[ARTICLE] The adverse event profile of levetiracetam: A meta-analysis on children and adults – Full Text HTML/PDF

Article Outline

1. 1. Introduction
2. 2. Methods
   1. 2.1. Criteria for considering studies in this review
      1. 2.1.1. Types of studies
      2. 2.1.2. Types of participants
      3. 2.1.3. Search methods for identification of studies
   2. 2.2. Analysis of adverse events
      1. 2.2.1. Selection of adverse events
      2. 2.2.2. Statistical analysis
3. 3. Results
   1. 3.1. Included studies
   2. 3.2. General tolerability
   3. 3.3. Treatment withdrawals
   4. 3.4. Adverse effects
   5. 3.5. Dose–effect correlations of statistically significant levetiracetam adverse effects
4. 4. Discussion
5. 5. Conclusions
6. Conflict of interest statement
7. Appendix A. Supplementary data
8. References

Highlights

• We analyzed the adverse events (AEs) profile of levetiracetam with a meta-analysis.
• A combined analysis of children and adults with any disease was performed.
• The risk of withdrawals was higher for patients taking levetiracetam than placebo.
• A general good tolerability profile of levetiracetam has been evidenced.
• We did not find a clear dose–response relationship for the significant AEs.

Abstract

Purpose: To analyze the adverse events (AEs) significantly associated with levetiracetam (LEV) therapy through a meta-analysis of all available double-blind, randomized placebo-controlled trials (RCTs), performed in any age, gender, ethnic background and disease. General tolerability and study withdrawals due to AEs associated with LEV treatment were also investigated. In addition, a dose–effect responses relationship for all variables was assessed.

Methods: RCTs were identified searching Medline (PubMed), Embase and Cochrane CENTRAL for the words “Levetiracetam” and “randomized controlled trial”, with different search strategies, setting the limits “humans” and “English”. Very common and common AEs according to the summary of product characteristics were investigated. RevMan version 5.2 was used for the statistical analyses. Risk difference with 95% confidence intervals was used to investigate the association of any AEs and withdrawal with LEV.

Results: Twenty-six studies with 2832 patients were included in the RCTs analysis. Nasopharyngitis, somnolence, dizziness, nervousness/irritability and asthenia/fatigue were statistically significant associated with LEV. In addition, LEV was significantly associated with an increased risk of AEs-related withdrawals. No dose–response relationship was found for any of the assessed variables.

Conclusions: This first large meta-analysis suggests that participants were more likely to discontinue LEV than placebo.The AE profile confirmed that LEV is associated with few unfavorable sedative, vestibulocerebellar and behavioral effects, such as nervousness and irritability. However, there does not seem to be a clear dose–response relationship.

Continue —> The adverse event profile of levetiracetam: A meta-analysis on children and adults – Seizure – European Journal of Epilepsy