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Eslicarbazepine acetate add‐on for drug‐resistant partial epilepsy

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Abstract

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Background

The majority of people with epilepsy will have a good prognosis, but up to 30% of patients will continue to have seizures despite several regimens of antiepileptic drugs. In this review we summarized the current evidence regarding eslicarbazepine acetate (ESL) when used as an add‐on treatment for drug‐resistant partial epilepsy.

Objectives

To evaluate the efficacy and tolerability of ESL when used as an add‐on treatment for people with drug‐resistant partial epilepsy.

Search methods

We searched the Cochrane Epilepsy Group Specialized Register (3 November 2011), The Cochrane Central Register of Controlled Trials (CENTRAL issue 4 of 4, The Cochrane Library 2011), and MEDLINE (1948 to October week 4, 2011). There were no language restrictions. We reviewed the reference lists of retrieved studies to search for additional reports of relevant studies. We also contacted the manufacturers of ESL and experts in the field for information about any unpublished or ongoing studies.

Selection criteria

Randomized placebo controlled double‐blind add‐on trials of ESL in people with drug‐resistant partial epilepsy.

Data collection and analysis

Two review authors independently selected trials for inclusion and extracted data. Outcomes investigated included 50% or greater reduction in seizure frequency; seizure freedom; treatment withdrawal; adverse effects; and drug interactions. Primary analyses were by intention to treat. The dose response relationship was evaluated in regression models.

Main results

Four trials (1146 participants) were included; all studies were funded by BIAL. The overall relative risk (RR) with 95% confidence interval (CIs) for 50% or greater reduction in seizure frequency outcome was 1.86 (95% CI 1.46 to 2.36). Dose regression analysis showed evidence that ESL reduced seizure frequency with an increase in efficacy with increasing doses of ESL. ESL was significantly associated with seizure freedom (RR 3.04, 95% CI 1.44 to 6.42). Participants seemed more likely (albeit not significantly) to have ESL withdrawn for adverse effects (RR 2.26, 95% CI 0.98 to 5.21) but not for any reason (RR 1.07, 95% CI 0.73 to 1.57). The following adverse effects were significantly associated with ESL: dizziness (RR 3.09, 99% CI 1.76 to 5.43); nausea (RR 3.06, 99% CI 1.07 to 8.74); and diplopia (RR 3.73, 99% CI 1.19 to 11.64).

Authors' conclusions

Eslicarbazepine acetate reduces seizure frequency when used as an add‐on treatment for people with drug‐resistant partial epilepsy. The trials included in this review were of short‐term duration and focused on adults.

PICO

Population
Intervention
Comparison
Outcome

El uso y la enseñanza del modelo PICO están muy extendidos en el ámbito de la atención sanitaria basada en la evidencia para formular preguntas y estrategias de búsqueda y para caracterizar estudios o metanálisis clínicos. PICO son las siglas en inglés de cuatro posibles componentes de una pregunta de investigación: paciente, población o problema; intervención; comparación; desenlace (outcome).

Para saber más sobre el uso del modelo PICO, puede consultar el Manual Cochrane.

Plain language summary

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Eslicarbazepine acetate add‐on for drug‐resistant partial epilepsy

Eslicarbazepine acetate is effective as a short‐term add‐on treatment for drug‐resistant focal epilepsy. Epilepsy is a recurrent seizure disorder caused by abnormal electrical discharges from the brain. The majority of patients with epilepsy can control seizures with a single antiepileptic drug, but there are still a considerable number of people who continue to have recurrent seizures with more than one antiepileptic drug. This review of trials found that the new drug eslicarbazepine acetate is effective when used in combination with other drugs to reduce the number of seizures in drug‐resistant partial epilepsy. Side effects associated with eslicarbazepine acetate were dizziness, nausea and double vision (diplopia). The included trials focused on adults and did not investigate the long‐term effects of eslicarbazepine acetate.