Dataset Information

Safety of Levetiracetam in Paediatrics: A Systematic Review.

ABSTRACT:

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.

SUBMITTER: Egunsola O

PROVIDER: S-EPMC4773020 | biostudies-literature | 2016

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Safety of Levetiracetam in Paediatrics: A Systematic Review.

Egunsola Oluwaseun O Choonara Imti I Sammons Helen Mary HM

PloS one 20160301 3

<h4>Objective</h4>To identify adverse events (AEs) associated with Levetiracetam (LEV) in children.<h4>Methods</h4>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. ...[more]

PMID: 26930201

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Project description:Background: Neonatal seizures are a common neurological emergency in newborns. Phenobarbital (PB) is the first-line antiepileptic drug (AED). However, PB has some side effects, such as hypotension and respiratory depression, and it can accelerate neuronal apoptosis in the immature brain. Levetiracetam (LEV), a new antiepileptic drug, has been used as a second-line drug for the treatment of neonatal seizures. Compared with PB, LEV has many advantages, including a low incidence of side effects and better neurodevelopmental outcomes. However, there are only a few systematic reviews of LEV for the treatment of neonatal seizures. Objective: To evaluate the efficacy and safety of LEV for neonatal seizures and to compare the efficacy, side effects, and neurological outcomes between LEV and PB in the treatment of neonatal seizures. Methods: The keywords LEV, PB, and neonatal seizure were searched in the MEDLINE, Cochrane Library, Web of Science, EMBASE, clinicaltrials.gov, and China National Knowledge Internet (CNKI) databases with a last update in July 2021 to collect high-quality studies. We collected studies studying the efficacy or safety of LEV and PB in the treatment of neonatal seizures applying strict inclusion and exclusion criteria. The data were extracted and outcome measures, including efficacy, side effect rate, neurological score, and mortality rate, were analyzed with RevMan 5.3 software. Results: Ten articles were finally included in the meta-analysis. The meta-analysis showed that there was no difference in efficacy between LEV and PB in the treatment of neonatal seizures. Compared with PB, the incidence of side effects of LEV was lower. The incidence of hypotension and respiratory depression in the LEV group was significantly lower than that in the PB group. In terms of long-term neurodevelopmental outcomes, there was no significant difference in the Bayley Scales of Infant Development (BSID) scores between LEV and PB. Conclusion: PB is still the first-line AED recommended by the WHO for the treatment of neonatal seizures. The new AEDs LEV may not have better efficacy than PB. At the same time, LEV is associated with better neurodevelopment outcomes and a lower risk of adverse effects. In addition, continuous EEG monitoring should be used to diagnose neonatal seizures to evaluate the severity of the seizures, remission, and drug efficacy. Systematic Review Registration: PROSPERO, identifier: CRD42021279029.

Project description:Objective Status epilepticus (SE) is a common neurological emergency that is defined as a prolonged seizure or a series of seizures which often leads to irreversible damage. Levetiracetam (LEV) and valproate (VPA) are second-line anti-seizure drugs that are frequently used in patients with established SE (ESE). This meta-analysis compared the efficacy and safety of LEV and VPA for the treatment of ESE. Method MEDLINE, EMBASE, Central Register of Controlled Trials (CENTRAL), and clinicaltrials.gov were searched by two authors, which identified six randomized controlled trials (RCTs) that compared LEV and VPA for ESE. Results The six RCTs included 1213 patients (LEV group, n = 593; VPA group, n = 620). Integrated patient data information display LEV was not superior to VPA in terms of clinical seizure termination (63.55% vs. 64.08%, respectively; relative risk [RR] = 1.03, 95% confidence interval [CI] = 0.94–1.11, p = 0.55), with no significant differences between LEV and VPA in terms of good functional outcome at discharge (Glasgow Outcome Scale [GOS] = 4 or 5), intensive care unit (ICU) admission, adverse events, and mortality. There was no statistically significant difference between the two drugs in different age groups. Previous multicenter studies have demonstrated that VPA was slightly more effective than LEV, whereas single-center studies showed the opposite results. In addition, LEV and VPA had similar rates of clinical seizure termination, ICU admission, and adverse events between the age subgroups (ages <18 and >18 years). Conclusions Levetiracetam (LEV) was not superior to valproate (VPA) in terms of efficacy or safety outcomes. In addition, children (<18 years) and adults (>18 years) might have similar responses to LEV and VPA. Additional RCTs are required to verify our results. Highlights • Levetiracetam (LEV) was not superior to valproate (VPA) in terms of efficacy outcomes.• There were no significant differences in the safety outcomes between LEV and VPA.• The efficacy of VPA was better in children than in adults, but the safety profile was opposite.• There is no difference in efficacy and safety between children and adults with LEV.

Project description:IntroductionClown intervention may playing an important complementary role in paediatric care and recovery. However, data on its utility for symptom cluster management of hospitalised children and adolescents in acute and chronic disorders are yet to be critically evaluated. As clinicians strive to minimise the psychological burden during hospitalisation, it is important that they are aware of the scientific evidences available regarding clown intervention for symptom management. We aim to provide quality evidence for the effectiveness of clown intervention on symptom cluster management in paediatric inpatients, both in acute and chronic conditions.Methods and analysisA systematic review of randomised controlled trials (RCTs) and non-randomised controlled trials (NRCTs) will be conducted. MEDLINE, Web of Science, Cochrane Library, Science Direct, PsycINFO, CINAHL, LILACS and SciELO databases will be searched from January 2000 to December 2018. Primary outcomes will include measures related with the effect of clown intervention on symptom cluster of paediatric inpatients (anxiety, depression, pain, fatigue, stress and psychological, emotional responses and perceived well-being). Study selection will follow the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines, and the methodological appraisal of the studies will be assessed by the Jadad Scale as well as Cochrane Risk-of-Bias Tool for RCTs, and Risk-of-Bias In Non-Randomized Studies Tool for NRCTs. A narrative synthesis will be conducted for all included studies. Also, if sufficient data are available, a meta-analysis will be conducted. The effect sizes will be generated using Hedges' g score for both fixed and random effect models. I 2 statistics will be used to assess heterogeneity and identify their potential sources.Ethics and disseminationAs it will be a systematic review, without human beings involvement, there will be no requirement for ethical approval. Findings will be disseminated widely through peer-reviewed publication and in various media, for example, conferences, congresses or symposia.Trial registration numberCRD42018107099.

Project description:IntroductionEpilepsy causes serious suffering in children and is associated with high morbidity and increased mortality. It impairs children's quality of life and places a heavy burden on healthcare resources. Levetiracetam has been used to prevent and treat paediatric epilepsy for years. To date, a number of systematic reviews have been performed to assess the efficacy and safety of levetiracetam in a variety of clinical settings. Conflicting outcomes have been reported for the same clinical issues. Our objective is to provide a comprehensive overview of the literature for clinicians and policymakers via an umbrella review that assesses the efficacy and safety of levetiracetam in children with epilepsy.Methods and analysisWe will follow the Joanna Briggs Institute's guidelines for umbrella reviews and the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement. The following seven databases will be searched from 1990 to February 2019: PubMed, Embase, Cochrane Database of Systematic Reviews, JBISRIR, EPPI, Epistemonikos and PROSPERO. We will provide evidence from existing systematic reviews and meta-analyses of randomised controlled trials regarding the use of levetiracetam in children with epilepsy. The intervention of interest is levetiracetam monotherapy and add-on therapies for prevention or treatment purposes. Studies will be individually selected and assessed by two reviewers. The primary outcomes of interest are epilepsy control, the efficacy of prophylaxis for provoked seizures and the mortality rate of children with epilepsy who received levetiracetam treatment. The secondary outcomes are adverse events and withdrawal rates due to adverse effects. The methodological quality of all reviews will be individually assessed by two reviewers using the 'A Measurement Tool to Assess Systematic Reviews' instrument. The Grading of Recommendations Assessment, Development and Evaluation assessment will be applied to evaluate the quality of evidence for each outcome of interest. A narrative description of an analysis of the systematic reviews will be tabulated to address objective and specific questions. Information from each review will be detailed in a table including the population, number of studies, total number of participants, year range of the trials, study designs of the primary trials, countries and settings of the trials, heterogeneity of results and assessment tools. Recommendations regarding each outcome of levetiracetam will be categorised based on a protocol.Ethics and disseminationThis umbrella review will inform clinical and policy decisions regarding the efficacy and safety of levetiracetam for preventing and treating paediatric epilepsy. The results will be disseminated through a peer-reviewed publication and conference presentations. Ethical approval is not required for this study.

Project description:ObjectivesTo summarise multivariable predictive models for 30-day unplanned hospital readmissions (UHRs) in paediatrics, describe their performance and completeness in reporting, and determine their potential for application in practice.DesignSystematic review.Data sourceCINAHL, Embase and PubMed up to 7 October 2021.Eligibility criteriaEnglish or German language studies aiming to develop or validate a multivariable predictive model for 30-day paediatric UHRs related to all-cause, surgical conditions or general medical conditions were included.Data extraction and synthesisStudy characteristics, risk factors significant for predicting readmissions and information about performance measures (eg, c-statistic) were extracted. Reporting quality was addressed by the 'Transparent Reporting of a multivariable prediction model for Individual Prognosis Or Diagnosis' (TRIPOD) adherence form. The study quality was assessed by applying six domains of potential biases. Due to expected heterogeneity among the studies, the data were qualitatively synthesised.ResultsBased on 28 studies, 37 predictive models were identified, which could potentially be used for determining individual 30-day UHR risk in paediatrics. The number of study participants ranged from 190 children to 1.4 million encounters. The two most common significant risk factors were comorbidity and (postoperative) length of stay. 23 models showed a c-statistic above 0.7 and are primarily applicable at discharge. The median TRIPOD adherence of the models was 59% (P25-P75, 55%-69%), ranging from a minimum of 33% to a maximum of 81%. Overall, the quality of many studies was moderate to low in all six domains.ConclusionPredictive models may be useful in identifying paediatric patients at increased risk of readmission. To support the application of predictive models, more attention should be placed on completeness in reporting, particularly for those items that may be relevant for implementation in practice.

Dataset Information

Safety of Levetiracetam in Paediatrics: A Systematic Review.

Objective

Methods

Results

Conclusion

Publications

Safety of Levetiracetam in Paediatrics: A Systematic Review.

Similar Datasets

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