The adverse event profile of levetiracetam: A meta-analysis on children and adults
| Autor: | Giovanni Prezioso, Francesco Chiarelli, Fabiana Di Sabatino, Alberto Verrotti, Valentina Franco, Gaetano Zaccara |
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| Jazyk: | angličtina |
| Předmět: |
Adult
medicine.medical_specialty Levetiracetam Adolescent Clinical Neurology Discontinuation Irritability Placebo law.invention Young Adult Randomized controlled trial law Internal medicine medicine Humans Child Psychiatry Adverse effect Aged Randomized Controlled Trials as Topic Aged 80 and over Dose-Response Relationship Drug business.industry Absolute risk reduction General Medicine Middle Aged Tolerability Piracetam Meta-analysis Neurology Child Preschool Adverse events Anticonvulsants Neurology (clinical) medicine.symptom business Antiepileptic drug medicine.drug |
| Zdroj: | Seizure. :49-55 |
| ISSN: | 1059-1311 |
| DOI: | 10.1016/j.seizure.2015.07.004 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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