Evidence map›Paper›PMID 35457375›Full record

ArticleInternational journal of environmental research and public health2022

Pharmacovigilance in Pediatric Patients with Epilepsy Using Antiepileptic Drugs.

Dorota Kopciuch, Krzysztof Kus, Jędrzej Fliciński, Barbara Steinborn, Anna Winczewska-Wiktor, Anna Paczkowska, Tomasz Zaprutko, Piotr Ratajczak, Elżbieta Nowakowska

Open access · goldAbstract read
In one paragraph

Article in International journal of environmental research and public health, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 1 pooled it
3.8field-weighted citation impact, top 7% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 1 synthesis or guideline pooled it, 11 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Review
  4. Observational
  5. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 1 institution in 1 country.

Dorota KopciuchDepartment of Pharmacoeconomics and Social Pharmacy, Karol Marcinkowski University of Medical Sciences, Rokietnicka 7, 60-806 Poznan, Poland.ORCID 0000-0001-6547-6112
Krzysztof KusDepartment of Pharmacoeconomics and Social Pharmacy, Karol Marcinkowski University of Medical Sciences, Rokietnicka 7, 60-806 Poznan, Poland.
Jędrzej FlicińskiDepartment of Developmental Neurology, Karol Marcinkowski University of Medical Sciences, Przybyszewskiego 49, 60-355 Poznan, Poland.
Barbara SteinbornDepartment of Developmental Neurology, Karol Marcinkowski University of Medical Sciences, Przybyszewskiego 49, 60-355 Poznan, Poland.ORCID 0000-0002-9839-8162
Anna Winczewska-WiktorDepartment of Developmental Neurology, Karol Marcinkowski University of Medical Sciences, Przybyszewskiego 49, 60-355 Poznan, Poland.ORCID 0000-0001-8551-3419
Anna PaczkowskaDepartment of Pharmacoeconomics and Social Pharmacy, Karol Marcinkowski University of Medical Sciences, Rokietnicka 7, 60-806 Poznan, Poland.ORCID 0000-0002-0058-2632
Tomasz ZaprutkoDepartment of Pharmacoeconomics and Social Pharmacy, Karol Marcinkowski University of Medical Sciences, Rokietnicka 7, 60-806 Poznan, Poland.ORCID 0000-0001-9737-9624
Piotr RatajczakDepartment of Pharmacoeconomics and Social Pharmacy, Karol Marcinkowski University of Medical Sciences, Rokietnicka 7, 60-806 Poznan, Poland.ORCID 0000-0001-9118-2222
Elżbieta NowakowskaDepartment of Pharmacology and Toxicology, Institute of Health Sciences, Collegium Medicum, University of Zielona Gora, Licealna 9 Street, 65-417 Zielona Góra, Poland.
University of Zielona Góra · PL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo investigate the occurrence of adverse effects of antiepileptic drugs (AEDs) in pediatric epileptic patients on mono- or polytherapy.

methodWe evaluated eighty consecutive patients that met the following inclusion criteria: aged ≤18 years; diagnosed with epilepsy for at least one year; a stable dose of AED for at least three months; verbal consent to participation in the study. Patients were asked if they had experienced any adverse drug reaction (ADR) related to the AED. Afterward, regardless of the answer, they were interviewed based on a detailed semi-structured questionnaire about the presence of ADRs associated with the AED. The data were analyzed regarding the use of monotherapy or polytherapy.

resultsNinety-seven percent of the patients reported having experienced ADRs related to AEDs. The greatest number of seizures affected the group of patients treated with monotherapy (both at baseline and at followup), but the greatest number of ADRs were observed among patients treated with polytherapy. In patients on monotherapy, the most frequent ADRs reported at baseline included fatigue and somnolence, and among patients with polytherapy, it was fatigue and hair loss.

conclusionChildren on polytherapy were significantly more likely to develop ADRs compared to those on monotherapy, but a statistically significant improvement in seizure frequency was also observed in the group of patients on polytherapy. Pharmacovigilance is very important in children with AEDs, so that ADRs can be identified early and managed appropriately.

Indexed as

Drug-Related Side Effects and Adverse ReactionsEpilepsyAnticonvulsantsChildFatigueHumansPharmacovigilanceSeizuresAnticonvulsantsadverse drug reactionsadverse eventsantiepileptic drugschildrenepilepsypediatric populationpharmacovigilance

Identifiers

PMID35457375
PMCPMC9028571
OpenAlexW4224246558

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.