Evidence map›Paper›PMID 30864528›Full record

Trial reportCurrent clinical pharmacology2020

Investigation of the Roles of New Antiepileptic Drugs and Serum BDNF Levels in Efficacy and Safety Monitoring and Quality of Life: A Clinical Research.

Meral Demir, Emel O Akarsu, Hava O Dede, Nerses Bebek, Sevda O Yıldız, Betül Baykan, Ahmet G Akkan

Open access · hybridAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Current clinical pharmacology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 1 pooled it
0.8field-weighted citation impact, top 28% 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

9 citing papers in PubMed, 1 synthesis or guideline pooled it, 12 citations in OpenAlex.

  1. Pooled it
  2. Trial
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  4. Article
  5. Article
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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

7 authors at 2 institutions in 1 country.

Meral DemirDepartment of Medical and Clinical Pharmacology, Istanbul Faculty of Medicine, Istanbul University, Fatih / Capa 34093, Istanbul, Turkey.
Emel O AkarsuDepartment of Neurology, Istanbul Faculty of Medicine, Istanbul University, Fatih / Capa 34093, Istanbul, Turkey.
Hava O DedeDepartment of Neurology, Istanbul Faculty of Medicine, Istanbul University, Fatih / Capa 34093, Istanbul, Turkey.
Nerses BebekDepartment of Neurology, Istanbul Faculty of Medicine, Istanbul University, Fatih / Capa 34093, Istanbul, Turkey.
Sevda O YıldızDepartment of Biostatistics, Istanbul Faculty of Medicine, Istanbul University, Fatih / Capa 34093, Istanbul, Turkey.
Betül BaykanDepartment of Neurology, Istanbul Faculty of Medicine, Istanbul University, Fatih / Capa 34093, Istanbul, Turkey.
Ahmet G AkkanDepartment of Medical and Clinical Pharmacology, Cerrahpasa Faculty of Medicine, Istanbul University, Cerrahpasa Street / Fatih 34093, Istanbul, Turkey.
Istanbul University · TRIstanbul University-Cerrahpaşa · TR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveWe aimed to determine the therapeutic drug monitoring (TDM) features and the relation to Brain-Derived Neurotrophic Factor (BDNF) of frequently used new antiepileptic drugs (NADs) including lamotrigine (LTG), oxcarbazepine (OXC), zonisamide (ZNS) and lacosamide (LCM). Moreover, we investigated their effect on the quality of life (QoL).

methodsEighty epileptic patients who had been using the NADs, and thirteen healthy participants were included in this cross-sectional study. The participants were randomized into groups. The QOLIE-31 test was used for the assessment of QoL. We also prepared and applied "Safety Test". HPLC method for TDM, and ELISA method for BDNF measurements were used consecutively.

resultsIn comparison to healthy participants, epileptic participants had lower marriage rate (p=0.049), education level (p˂0.001), alcohol use (p=0.002). BDNF levels were higher in patients with focal epilepsy (p=0.013) and in those with higher education level (p=0.016). There were negative correlations between serum BDNF levels and serum ZNS levels (p=0.042) with LTGpolytherapy, serum MHD levels (a 10-monohydroxy derivative of OXC, p=0.041) with OXCmonotherapy. There was no difference in BDNF according to monotherapy-polytherapy, drugresistant groups, regarding seizure frequency. There was a positive correlation between total health status and QoL (p˂0.001). QOLIE-31 overall score (OS) was higher in those with OXCmonotherapy (76.5±14.5). OS (p˂0.001), seizure worry (SW, p=0.004), cognition (C, p˂0.001), social function (SF, p˂0.001) were different in the main groups. Forgetfulness was the most common unwanted effect.

conclusionWhile TDM helps the clinician to use more effective and safe NADs, BDNF may assist in TDM for reaching the therapeutic target in epilepsy.

Indexed as

Quality of LifeAdolescentAdultAnticonvulsantsBrain-Derived Neurotrophic FactorChromatography, High Pressure LiquidCross-Sectional StudiesDrug MonitoringDrug Therapy, CombinationEnzyme-Linked Immunosorbent AssayEpilepsyFemaleHealth StatusHumansMaleMiddle AgedAnticonvulsantsBDNF protein, humanBrain-Derived Neurotrophic FactorBDNFefficacyEpilepsynew antiepileptic drugsQOLIE-31safety.TDM

Identifiers

PMID30864528
PMCPMC7497568
OpenAlexW2921688376

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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.