Evidence map›Paper›PMID 31260089›Full record

Trial reportEpilepsia2019

Serum sodium levels and related treatment-emergent adverse events during eslicarbazepine acetate use in adults with epilepsy.

Robert T Wechsler, Rodney A Radtke, Michael Smith, David G Vossler, Laura Strom, Eugen Trinka, Hailong Cheng, Todd Grinnell, David Blum, Mariana Vieira and 2 more

Open access · bronzeAbstract readClinical Trial, Phase III
In one paragraph

Trial report in Epilepsia, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
1.4field-weighted citation impact, top 17% 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

6 citing papers in PubMed, 8 citations in OpenAlex.

  1. Trial
  2. Oxcarbazepine and Hyponatremia.Medicina (Kaunas, Lithuania) · 2022
    Article
  3. Article
  4. Review
  5. Article
  6. Review
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 8 institutions in 3 countries.

Robert T WechslerIdaho Comprehensive Epilepsy Center, Boise, Idaho.ORCID 0000-0002-3146-986X
Rodney A RadtkeDuke University School of Medicine, Durham, North Carolina.
Michael SmithRush University Medical Center, Chicago, Illinois.
David G VosslerUniversity of Washington, Valley Medical Center, Renton, Washington.
Laura StromUniversity of Colorado Anschutz Medical Campus, Aurora, Colorado.
Eugen TrinkaUniklinikum Salzburg, Christian-Doppler-Klinik, Salzburg, Austria.
Hailong ChengSunovion Pharmaceuticals, Inc., Marlborough, Massachusetts.
Todd GrinnellSunovion Pharmaceuticals, Inc., Marlborough, Massachusetts.
David BlumSunovion Pharmaceuticals, Inc., Marlborough, Massachusetts.
Mariana VieiraBIAL - Portela & Cª., S.A., Coronado (S. Romão e S. Mamede), Portugal.
Joana MoreiraBIAL - Portela & Cª., S.A., Coronado (S. Romão e S. Mamede), Portugal.
Francisco RochaBIAL - Portela & Cª., S.A., Coronado (S. Romão e S. Mamede), Portugal.
Bial (Portugal) · PTSunovion (United States) · USChristian Doppler Klinik · ATDuke University · USFamily Medicine Residency of Idaho · USRush University Medical Center · USUniversity of Colorado Anschutz Medical Campus · USUniversity of Washington · US

Funding

BIAL - Portela & Cª, S.A., Coronado (S. Romão e S. Mamede), PortugalSunovion Pharmaceuticals Inc., Marlborough, Massachusetts
6 · The paper itself

Abstract

objectiveTo examine the frequency of hyponatremia and potentially related symptoms in clinical trials of eslicarbazepine acetate (ESL) in adults with focal- (partial-) onset seizures.

methodsThis post hoc, exploratory analysis included data from three controlled phase 3 trials of adjunctive ESL (400-1200 mg once daily), two phase 3 trials of ESL monotherapy (1200-1600 mg once daily), and their open-label extension studies. Exploratory endpoints included clinical laboratory measurements of serum sodium concentrations ([Na

resultsThe controlled trials of adjunctive ESL and ESL monotherapy included 1447 (placebo, n = 426; ESL, n = 1021) and 365 (ESL, n = 365) patients, respectively; 639 and 274 patients continued onto uncontrolled, open-label extensions. In the controlled and uncontrolled trials ≤3.3% of patients taking ESL had a minimum postdose [Na SIGNIFICANCE: Reductions in serum sodium concentrations and hyponatremia-related TEAEs occurred in a small number of patients taking ESL. Suspected hyponatremia should be confirmed and monitored via [Na

Indexed as

AdolescentAdultAgedAnticonvulsantsDibenzazepinesEpilepsies, PartialEpilepsyHumansHyponatremiaMiddle AgedSodiumYoung AdultAnticonvulsantsDibenzazepineseslicarbazepineSodiumdibenzazepine carboxamidesfocal seizureshyponatremiasafety

Identifiers

PMID31260089
PMCPMC6852335
OpenAlexW2953562351

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.