Evidence map›Paper›PMID 26915469›Full record

Trial reportActa neurologica Scandinavica2016

Real-world data on eslicarbazepine acetate as add-on to antiepileptic monotherapy.

M Holtkamp, R McMurray, M Bagul, R Sousa, E Kockelmann

Open access · hybridAbstract readClinical TrialMulticenter Study
In one paragraph

Trial report in Acta neurologica Scandinavica, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 1 pooled it
5.4field-weighted citation impact, top 4% 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

12 citing papers in PubMed, 1 synthesis or guideline pooled it, 29 citations in OpenAlex.

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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

5 authors at 4 institutions in 4 countries.

M HoltkampEpilepsy-Center Berlin-Brandenburg, Department of Neurology, Charité - Universitätsmedizin Berlin, Berlin, Germany.
R McMurrayEisai Europe Ltd, Hatfield, Hertfordshire, UK.
M BagulEisai Europe Ltd, Hatfield, Hertfordshire, UK.
R SousaBIAL - Portela & Ca. SA, S. Mamede do Coronado, Portugal.
E KockelmannEisai GmbH Frankfurt, Frankfurt, Germany.
Eisai (United Kingdom) · GBBial (Portugal) · PTEisai (Germany) · DEIn-Q-Tel · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo assess retention, tolerability, and safety, efficacy and effects on quality of life (QoL) of eslicarbazepine acetate (ESL) add-on treatment over 6 months in a real-world adult population with partial-onset seizures.

methodsThis non-interventional, multicenter, prospective study was performed in eight European countries. Adult patients (n = 247) for whom the physician had decided to initiate ESL as add-on to an existing antiepileptic drug (AED) monotherapy were invited to participate. The study comprised three visits: baseline, and after 3 and 6 months. Data on ESL retention, efficacy, tolerability, safety, and QoL were collected.

resultsAfter 6 months, the retention rate of ESL was 82.2%, and 81.8% of patients reported a reduction of seizure frequency of at least 50%; 39.2% of patients reported seizure freedom at this time. The mean QOLIE-10 score improved from 2.9 (SD ± 0.8) at baseline to 2.1 (SD ± 0.8) after 6 months. 109 adverse events (AEs) were reported in 57 patients (26.0%); the majority were rated as related to ESL by the investigator and led to a discontinuation of ESL in 25 patients (11.4%). Eight patients (3.7%) suffered at least one serious AE. The most frequently reported AEs were dizziness, headache, convulsion, and fatigue.

conclusionsThis study shows that ESL was well tolerated and efficacious as add-on therapy to one baseline AED. The use of ESL in patients less refractory than those included in previous clinical trials led to higher responder and seizure freedom rates. No new safety issues were observed.

Indexed as

AdultAnticonvulsantsDibenzazepinesDrug Therapy, CombinationEpilepsies, PartialEuropeFemaleHumansMaleMiddle AgedProspective StudiesQuality of LifeTreatment OutcomeYoung AdultAnticonvulsantsDibenzazepineseslicarbazepine acetateadd-onepilepsyeslicarbazepine acetateonce-dailypartial-onset seizuresretention

Identifiers

PMID26915469
PMCPMC5067651
OpenAlexW2274967460

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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.