Evidence map›Paper›PMID 30642405›Full record

Observational studyBMC pharmacology & toxicology2019

Adverse drug reactions associated with six commonly used antiepileptic drugs in southern China from 2003 to 2015.

Yanru Du, Jiahe Lin, Jingzan Shen, Siqi Ding, Mengqian Ye, Li Wang, Yi Wang, Xinshi Wang, Niange Xia, Rongyuan Zheng and 2 more

Open access · goldAbstract readObservational Study
In one paragraph

Observational study in BMC pharmacology & toxicology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed, 2 pooled it
6.9field-weighted citation impact, top 3% 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

15 citing papers in PubMed, 2 syntheses or guidelines pooled it, 35 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Article
  4. Observational
  5. Article
  6. Article
  7. Review
  8. Observational
  9. Article
  10. Article
  11. Article
  12. Valproic acid for children below 2 years of age with epilepsy.Neurosciences (Riyadh, Saudi Arabia) · 2021
    Article
  13. Article
  14. Review
  15. 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

12 authors at 2 institutions in 1 country.

Yanru DuDepartment of Neurology, The First Affiliated Hospital of Wenzhou Medical University, Shangcai Village, Ouhai District, Wenzhou, Zhejiang Province, People's Republic of China.
Jiahe LinDepartment of Neurology, The First Affiliated Hospital of Wenzhou Medical University, Shangcai Village, Ouhai District, Wenzhou, Zhejiang Province, People's Republic of China.
Jingzan ShenDepartment of Neurology, The First Affiliated Hospital of Wenzhou Medical University, Shangcai Village, Ouhai District, Wenzhou, Zhejiang Province, People's Republic of China.
Siqi DingDepartment of Neurology, The First Affiliated Hospital of Wenzhou Medical University, Shangcai Village, Ouhai District, Wenzhou, Zhejiang Province, People's Republic of China.
Mengqian YeDepartment of Neurology, The First Affiliated Hospital of Wenzhou Medical University, Shangcai Village, Ouhai District, Wenzhou, Zhejiang Province, People's Republic of China.
Li WangDepartment of Neurology, The First Affiliated Hospital of Wenzhou Medical University, Shangcai Village, Ouhai District, Wenzhou, Zhejiang Province, People's Republic of China.
Yi WangDepartment of Preventive Medicine, School of Public Health and Management, Wenzhou Medical University, Wenzhou, Zhejiang Province, People's Republic of China.
Xinshi WangDepartment of Neurology, The First Affiliated Hospital of Wenzhou Medical University, Shangcai Village, Ouhai District, Wenzhou, Zhejiang Province, People's Republic of China.
Niange XiaDepartment of Neurology, The First Affiliated Hospital of Wenzhou Medical University, Shangcai Village, Ouhai District, Wenzhou, Zhejiang Province, People's Republic of China.
Rongyuan ZhengDepartment of Neurology, The First Affiliated Hospital of Wenzhou Medical University, Shangcai Village, Ouhai District, Wenzhou, Zhejiang Province, People's Republic of China.
Hong ChenDepartment of Psychiatry, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, Zhejiang Province, People's Republic of China.
Huiqin XuDepartment of Neurology, The First Affiliated Hospital of Wenzhou Medical University, Shangcai Village, Ouhai District, Wenzhou, Zhejiang Province, People's Republic of China. xuhuiqin@wmu.edu.cn.
Wenzhou Medical University · CNFirst Affiliated Hospital of Wenzhou Medical University · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThis active, open observational study aimed to investigate adverse drug reactions (ADRs) associated with six commonly used antiepileptic drugs (AEDs) in southern Chinese outpatients with epilepsy from 2003 to 2015.

methodsThe Wenzhou Epilepsy Follow-Up Registry Database (WEFURD) was established by a single epilepsy center in China in January 2003 to record AED efficacy and the associated ADRs by registered outpatients diagnosed with epilepsy. We reviewed the data of outpatients who had only taken one or more of six commonly used AEDs, namely, carbamazepine (CBZ), valproate (VPA), lamotrigine (LTG), oxcarbazepine (OXC), topiramate (TPM) and levetiracetam (LEV), and were registered in the WEFURD between 2003 and 2015. We evaluated the ADRs caused by the single or combined use of the above six specific AEDs based on the WHO-UMC scale. The data of the ADRs were categorized by age, sex, number of AEDs related to ADRs, medications, seriousness of ADRs, causality levels of the WHO-UMC scale and system organ class (SOC). The unit of analysis was one ADR.

resultsA total of 3069 epilepsy outpatients (1807 outpatients with 5049 eligible ADRs and 1262 outpatients without ADRs) were included. The overall ADR rate was 58.88% (1807/3069). An average of 2.79 ADRs (5049/1807) occurred per patient with an ADR; 53.8% of the 5049 ADRs were recorded in females, and 50.4% were caused by monotherapy. Of the ADRs, 10.6% (537/5049) were severe adverse reactions (SARs), including 34 serious adverse effects (SAEs). The SAR rates caused by one, two and three or more AEDs were 9.9, 10.0 and 19.6%, respectively (p <  0.001). Eighteen SOC categories were identified, and the top three were psychiatric disorders (1633/5049, 32.3%), neurological disorders (1222/5049, 24.2%) and gastrointestinal disorders (564/5049, 11.2%). Of the 537 SARs, skin and appendage disorders accounted for 24.4% (131/537). Among the 34 SAEs, serious allergies, fetal malformations, renal calculus and pancreatitis accounted for the majority.

conclusionsOur findings suggest that clinicians should pay attention to psychiatric ADRs and be alert for SARs, especially when three or more AEDs are used together. Moreover, active surveillance might provide another method of pharmacovigilance in China.

Indexed as

AdolescentAdultAgedAged, 80 and overAnticonvulsantsChildChild, PreschoolChinaEpilepsyFemaleHumansInfantLamotrigineLevetiracetamMaleMiddle AgedAnticonvulsantsLamotrigineLevetiracetamOxcarbazepineTopiramateValproic AcidAdverse drug reactionsAntiepileptic drugChinaSevere adverse reactions

Identifiers

PMID30642405
PMCPMC6332546
OpenAlexW2910770615

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LicenceCC BY
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Registered trials

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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.