Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Meta-Analysis
. 2017 Oct 25;10(10):CD008907.
doi: 10.1002/14651858.CD008907.pub3.

Eslicarbazepine acetate add-on for drug-resistant partial epilepsy

Xian-Chao Chang  1 , Hai Yuan, Yi Wang, Hui-Qin Xu, Wen-Ke Hong, Rong-Yuan Zheng
Affiliations
Meta-Analysis

Eslicarbazepine acetate add-on for drug-resistant partial epilepsy

Xian-Chao Chang et al. Cochrane Database Syst Rev. .

Update in

Abstract

Background: This is an updated version of the Cochrane Review published in the Cochrane Library 2011, Issue 12.The majority of people with epilepsy have a good prognosis, but up to 30% of people 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: The searches for the original review were run in November 2011. Subsequently, we searched the Cochrane Epilepsy Group Specialized Register (6 December 2016), the Cochrane Central Register of Controlled Trials (CENTRAL 2016, Issue 11) and MEDLINE (1946 to 6 December 2016). 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 We also contacted the manufacturers of ESL and experts in the field for information about any unpublished or ongoing studies.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 (ITT). The dose-response relationship was evaluated in regression models.

Main results: We included five trials (1799 participants) rated at low risk of bias; all studies were funded by BIAL. The overall risk ratio (RR) with 95% confidence interval (CI) for 50% or greater reduction in seizure frequency was 1.71 (95% CI 1.42 to 2.05). 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 2.90, 95% CI 1.49 to 5.68). Participants were more likely to have ESL withdrawn for adverse effects (RR 2.66, 95% CI 1.42 to 4.96) but not for any reason (RR 1.19, 95% CI 0.86 to 1.64). The following adverse effects were significantly associated with ESL: dizziness (RR 2.81, 99% CI 1.86 to 4.27); nausea (RR 2.61, 99% CI 1.36 to 5.01); diplopia (RR 4.14, 99% CI 1.74 to 9.84); somnolence (RR 1.71, 99% CI 1.11 to 2.63) and vomiting (RR 3.30, 99% CI 1.34 to 8.13). Overall the quality of the evidence was rated as moderate to high.

Authors' conclusions: ESL 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. One new trial has been included in this update, but the conclusions are unchanged.

PubMed Disclaimer

Conflict of interest statement

None known.

Figures

1
1
Study flow diagram for update.
2
2
Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
3
3
Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
See this image and copyright information in PMC

Update of

References

References to studies included in this review

Ben‐Menachem 2010 {published data only}
    1. Ben‐Menachem E, Gabbai AA, Hufnagel A, Maia J, Almeida L, Soares‐da‐Silva P. Eslicarbazepine acetate as adjunctive therapy in adult patients with partial epilepsy. Epilepsy Research 2010;89:278‐85. - PubMed
Elger 2007 {published data only}
    1. Elger C, Bialer M, Cramer JA, Maia J, Almeida L, Soares‐da‐Silva P. Eslicarbazepine acetate: a double‐blind, add‐on, placebo‐controlled exploratory trial in adult patients with partial‐onset seizures. Epilepsia 2007;48:497‐504. - PubMed
Elger 2009 {published data only}
    1. Elger C, Halasz P, Maia J, Almeida L, Soares‐da‐Silva P. Efficacy and safety of eslicarbazepine acetate as adjunctive treatment in adults with refractory partial‐onset seizures: a randomized, double‐blind, placebo‐controlled, parallel‐group phase III study. Epilepsia 2009;50:454‐63. - PubMed
Gil‐Nagel 2009 {published data only}
    1. Gil‐Nagel A, Lopes‐Lima J, Almeida L, Maia J, Soares‐da‐Silva P. Efficacy and safety of 800 and 1200 mg eslicarbazepine acetate as adjunctive treatment in adults with refractory partial‐onset seizures. Acta Neurologica Scandinavica 2009;120:281‐7. - PubMed
Sperling 2015 {published data only}
    1. Sperling MR, Abou‐Khalil B, Harvey J, Rogin JB, Biraben A, Galimberti CA, et al. Eslicarbazepine acetate as adjunctive therapy in patients with uncontrolled partial‐onset seizures: results of a phase III, double‐blind, randomized, placebo‐controlled trial. Epilepsia 2015; Vol. 53, issue 2:244‐53. - PMC - PubMed

References to studies excluded from this review

Aneja 2013 {published data only}
    1. Aneja Satinder, Sharma Suvasini. Newer anti‐epileptic drugs. Indian Pediatrics 2013;50:1033‐40. - PubMed
Cramer 2015 {published data only}
    1. Cramer Joyce A, Velez Fulton F, Anastassopoulos Kathryn P, Bond T Christopher, Gilliam Frank G, Ryvlin Philippe, et al. Severity and burden of partial‐onset seizures in a phase III trial of eslicarbazepine acetate. Epilepsy & Behavior 2015;53:149‐53. - PubMed
Ermolenko 2014 {published data only}
    1. Ermolenko N A, Buchneva I A. [Exalief as a newer antiepileptic drug for adjunctive therapy of refractory partial‐onset seizures]. Zhurnal Nevrologii i Psikhiatrii Imeni S.S. Korsakova 2014;114:129‐34. - PubMed
Grunze 2015 {published data only}
    1. Grunze Heinz, Kotlik Eduardo, Costa Raquel, Nunes Teresa, Falcao Amilcar, Almeida Luis, et al. Assessment of the efficacy and safety of eslicarbazepine acetate in acute mania and prevention of recurrence: experience from multicentre, double‐blind, randomised phase II clinical studies in patients with bipolar disorder I. Journal of Affective Disorders 2015;174:70‐82. - PubMed
Jacobson 2015 {published data only}
    1. Jacobson M P, Pazdera L, Bhatia P, Grinnell T, Cheng H, Blum D. Efficacy and safety of conversion to monotherapy with eslicarbazepine acetate in adults with uncontrolled partial‐onset seizures: a historical‐control phase III study. BMC neurology 2015;15:46. - PMC - PubMed
Keating 2014 {published data only}
    1. Keating Gillian M. Eslicarbazepine acetate: a review of its use as adjunctive therapy in refractory partial‐onset seizures. CNS Drugs 2014;28:583‐600. - PubMed
Moreira 2012 {published data only}
    1. Moreira J, TrinkaE, Mota F, Nunes T, Soares da Silva P. Design of a phase III, double‐dummy, active‐controlled, multi‐national non‐inferiority monotherapy trial of eslicarbazepine acetate versus controlled‐release carbamazepine In adults with partial‐onset seizures [abstract]. Epilepsia 2012;53:122, Abstract no: p415.
Sperling 2015a {published data only}
    1. Sperling Michael R, Harvey Jay, Grinnell Todd, Cheng Hailong, Blum David, Study Team. Efficacy and safety of conversion to monotherapy with eslicarbazepine acetate in adults with uncontrolled partial‐onset seizures: a randomized historical‐control phase III study based in North America. Epilepsia 2015;56:546‐55. - PMC - PubMed
Sperling 2016 {published data only}
    1. Sperling Michael R, French Jacqueline, Jacobson Mercedes P, Pazdera Ladislav, Gough Mallory, Cheng Hailong, et al. Conversion to eslicarbazepine acetate monotherapy: A pooled analysis of 2 phase III studies. Neurology 2016;86:1095‐102. - PMC - PubMed
Zaccara 2015 {published data only}
    1. Zaccara Gaetano, Giovannelli Fabio, Cincotta Massimo, Carelli Alessia, Verrotti Alberto. Clinical utility of eslicarbazepine: current evidence. Drug design, development & therapy 2015;9:781‐9. - PMC - PubMed

References to ongoing studies

NCT00988429 {unpublished data only}
    1. NCT00988429. Efficacy and safety study of eslicarbazepine acetate (BIA 2 093) as adjunctive therapy for refractory partial seizures in children. https://clinicaltrials.gov/ct2/show/NCT00988429 (first received 01 October 1999).

Additional references

Almeida 2007
    1. Almeida L, Soares‐da‐Silva P. Eslicarbazepine acetate (BIA 2‐093). Neurotherapeutics 2007;4(1):88‐96. - PMC - PubMed
GRADEpro 2004 [Computer program]
    1. Brozek J, Oxman A, Schünemann H. GRADEpro Version 3.6 for Windows. Hamilton (ON): GRADE Working Group, McMaster University, 2004.
Higgins 2011
    1. Higgins JPT, Green S, editor(s). Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0 (updated March 2011), The Cochrane Collaboration, 2011. Available from handbook.cochrane.org.
Lefebvre 2011
    1. Lefebvre C, Manheimer E, Glanville J. Chapter 6: Searching for studies. In: Higgins JPT, Green S, editor(s). Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0 (updated March 2011). The Cochrane Collaboration, 2011. Available from handbook.cochrane.org.
McCormack 2009
    1. McCormack PL, Robinson DM. Eslicarbazepine acetate. CNS Drugs 2009;23(1):71‐9. - PubMed
McCullagh 1989
    1. McCullagh P, Nelder JA. Generalized Linear Models. 2nd Edition. London (UK): Chapman and Hall, 1989.
Mestre 2009
    1. Mestre T, Ferreira J. Eslicarbazepine acetate: a new option for the treatment of focal epilepsy. Expert Opinion on Investigational Drugs 2009;18(2):221‐9. - PubMed
RevMan 2014 [Computer program]
    1. Nordic Cochrane Centre, The Cochrane Collaboration. Review Manager (RevMan). Version 5.3. Copenhagen: Nordic Cochrane Centre, The Cochrane Collaboration, 2014.
Sander 2003
    1. Sander JW. The epidemiology of epilepsy revisited. Current Opinion in Neurology 2003;16(2):165‐70. - PubMed
Schuele 2008
    1. Schuele SU, Luders HO. Intractable epilepsy: management and therapeutic alternatives. Lancet Neurology 2008;7(6):514‐24. - PubMed
Schünemann 2011
    1. Schünemann HJ, Oxman AD, Vist GE, Higgins JPT, Deeks JJ, Glasziou P. Chapter 12: Interpreting results and drawing conclusions. In: Higgins JPT, Green S, editors(s). Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0 (updated March 2011). The Cochrane Collaboration, 2011. Available from handbook.cochrane.org.
Walker 1997
    1. Walker MC, Sander JW. Difficulties in extrapolating from clinical trial data to clinical practice: the case of antiepileptic drugs. Neurology 1997;49(2):333‐7. - PubMed

References to other published versions of this review

Chang 2010
    1. Chang XC, Yuan H, Wang Y, Xu HQ, Zheng RY. Eslicarbazepine acetate add‐on for drug‐resistant partial epilepsy. Cochrane Database of Systematic Reviews 2010, Issue 12. [DOI: 10.1002/14651858.CD008907] - DOI - PubMed
Chang 2011
    1. Chang XC, Yuan H, Wang Y, Xu HQ, Zheng RY. Eslicarbazepine acetate add‐on for drug‐resistant partial epilepsy. Cochrane Database of Systematic Reviews 2011, Issue 12. [DOI: 10.1002/14651858.CD008907.pub2] - DOI - PubMed

Publication types

LinkOut - more resources