Evidence map›Paper›PMID 25488477›Full record

ArticleClinical drug investigation2015

Early add-on lacosamide in a real-life setting: results of the REALLY study.

Vicente Villanueva, Mercedes Garcés, Elena López-Gomáriz, José María Serratosa, Beatriz González-Giráldez, Jaime Parra, Juan Rodríguez-Uranga, Manuel Toledo, Francisco Javier López González, Pedro Bermejo and 11 more

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Article in Clinical drug investigation, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed, 2 pooled it
–field-weighted citation impact
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

14 citing papers in PubMed, 2 syntheses or guidelines pooled it.

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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

21 authors.

Vicente VillanuevaHospital Universitario y Politécnico La Fe, Bulevard Sur, s/n, Carretera de Malilla, 46026, Valencia, Spain, vevillanuevah@yahoo.es.
Mercedes Garcés
Elena López-Gomáriz
José María Serratosa
Beatriz González-Giráldez
Jaime Parra
Juan Rodríguez-Uranga
Manuel Toledo
Francisco Javier López González
Pedro Bermejo
Pau Giner
Ascensión Castillo
Albert Molins
Dulce Campos
José Ángel Mauri
Rosario Muñoz
Macarena Bonet
Pedro Serrano-Castro
Ana del Villar
Rosa Ana Saiz-Díaz
REALLY Study Group

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

objectivesMany patients with epilepsy are treated with antiepileptic drug (AED) polytherapy. Several factors influence the choice of early add-on therapy, and deciding on the most appropriate drug can be difficult. This study aimed to assess the efficacy and tolerability of lacosamide as early add-on therapy in patients with partial-onset seizures.

methodsREALLY (REtrospective study of lAcosamide as earLy add-on aLong one Year) was a multicenter, retrospective, 1-year, real-life study. Patients included were aged older than 16 years, had partial-onset seizures, and were treated with lacosamide as add-on therapy after one or two prior AEDs. Data were collected retrospectively from clinical records. The primary study objective was to assess the efficacy of lacosamide over 12 months (seizure-free and responder rates), and the secondary objective was to assess the tolerability of lacosamide at 3, 6, and 12 months [adverse events (AEs) and discontinuation].

resultsOne hundred and ninety-nine patients were enrolled in the study; 89 patients (44.7 %) had tried one AED and 110 patients (55.3 %) had tried two AEDs before lacosamide. At 12 months, the proportion of patients who were seizure free was 44.9 %, and 76 % of patients were responders. The seizure-free rate at 12 months for patients who had previously received one or two AEDs was 58 and 34.3 %, and the responder rate at 12 months was 83.0 and 70.4 %, respectively. The AE rate was 21.5 % at 3 months, 27.1 % at 6 months, and 31.2 % at 12 months, with 7.0 % of patients discontinuing treatment because of an AE. The most common AE reported was dizziness (11.6 %). Cryptogenic epilepsy, a higher number of prior AEDs, and the use of a sodium channel blocker at onset were associated with a worse outcome. The number of concomitant AEDs decreased over 1 year (Z = 5.89; p < 0.001). Twenty-two patients were converted to lacosamide monotherapy with at least one evaluation ≥6 months from the beginning of monotherapy conversion.

conclusionsLacosamide was effective and well tolerated as early add-on treatment in patients who had received one or two previous AEDs.

Indexed as

AcetamidesAdolescentAdultAgedAged, 80 and overAnticonvulsantsDrug Therapy, CombinationFemaleHumansLacosamideMaleMiddle AgedRetrospective StudiesSeizuresYoung AdultAcetamidesAnticonvulsantsLacosamide

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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.