Long-term safety and efficacy of eslicarbazepine acetate in patients with focal seizures: Results of the 1-year ESLIBASE retrospective study

Epilepsy Research

Volumn 108, Issue 7, 2014, Pages 1243-1252

  Villanueva, V ^a   Serratosa, J M ^b   Guillamon E ^a   Garces M ^a   Giraldez B G ^b   Toledo, M ^c   Salas Puig, J ^c   Lopez Gonzalez F J ^d   Flores, J ^e   Rodriguez Uranga J ^f   Castillo, A ^g   Mauri, J A ^h   Camacho, J L ^h   Lopez Gomariz E ⁱ   Giner, P ^j   Torres, N ^j   Palau, J ^k   Molins, A ^l  

^a HOSPITAL UNIVERSITARIO LA FE   (Spain)

^b HOSPITAL UNIVERSITARIO FUNDACIÓN JIMÉNEZ DÍAZ   (Spain)

^c HOSPITAL UNIVERSITARI DE BELLVITGE   (Spain)

^d HOSPITAL CLÍNICO UNIVERSITARIO   (Spain)

^e HOSPITAL UNIVERSITARIO NUESTRA SEÑORA DE CANDELARIA   (Spain)

^f Instituto de Especialidades Neurológicas IENSA Clinica Sagrado Corazón   (Spain)

^g HOSPITAL GENERAL UNIVERSITARIO DE VALENCIA   (Spain)

^h HOSPITAL CLÍNICO UNIVERSITARIO LOZANO BLESA   (Spain)

ⁱ HOSPITAL LLUÍS ALCANYÍS   (Spain)

^j HOSPITAL UNIVERSITARIO DR PESET   (Spain)

^k HOSPITAL DE MANISES   (Spain)

^l HOSPITAL JOSEP TRUETA   (Spain)

more..

Author keywords

Antiepileptic drug; ESLIBASE; Eslicarbazepine acetate; Focal seizures; Real life setting

Indexed keywords

ALANINE AMINOTRANSFERASE; ANTICONVULSIVE AGENT; ASPARTATE AMINOTRANSFERASE; CARBAMAZEPINE; ESLICARBAZEPINE ACETATE; ETIRACETAM; HARKOSERIDE; LAMOTRIGINE; OXCARBAZEPINE; PREGABALIN; SODIUM CHANNEL BLOCKING AGENT; TOPIRAMATE; VALPROIC ACID; DIBENZAZEPINE DERIVATIVE; VOLTAGE GATED SODIUM CHANNEL BLOCKING AGENT;

ABNORMAL LABORATORY RESULT; ADULT; AGGRESSIVENESS; ANXIETY DISORDER; ARTICLE; ASTHENIA; BEHAVIOR DISORDER; BLURRED VISION; BODY WEIGHT DISORDER; BRADYPSYCHIA; CHILD; CLINICAL PRACTICE; CLINICAL STUDY; COGNITIVE DEFECT; CONTROLLED STUDY; CORTICAL DYSPLASIA; DEPRESSION; DIPLOPIA; DISEASE SEVERITY; DIZZINESS; DRUG DOSE INCREASE; DRUG DOSE TITRATION; DRUG EFFICACY; DRUG MECHANISM; DRUG SAFETY; DRUG SUBSTITUTION; DRUG TOLERABILITY; DRUG WITHDRAWAL; EDEMA; EPILEPSY; EPILEPTIC STATE; FEMALE; FOCAL EPILEPSY; HEADACHE; HIPPOCAMPAL SCLEROSIS; HUMAN; HYPONATREMIA; INSOMNIA; MAJOR CLINICAL STUDY; MALE; MEMORY DISORDER; MENTAL INSTABILITY; NAUSEA; NON INTERVENTIONAL STUDY; OUTCOME ASSESSMENT; PARESTHESIA; PERI ICTAL PSYCHOSIS; POLYURIA; PRIORITY JOURNAL; PRURITUS; PSYCHOSIS; RASH; RESTLESSNESS; RETROSPECTIVE STUDY; SCHOOL CHILD; SEXUAL DYSFUNCTION; SIDE EFFECT; SOMNOLENCE; STOMACH DISEASE; TREATMENT DURATION; TREATMENT RESPONSE; TREMOR; UNSPECIFIED SIDE EFFECT; VASCULAR EPILEPSY; VISUAL HALLUCINATION; ADOLESCENT; AGED; LONGITUDINAL STUDY; MIDDLE AGED; NONPARAMETRIC TEST; SEIZURES; TIME; VERY ELDERLY; YOUNG ADULT;

ADOLESCENT; ADULT; AGED; AGED, 80 AND OVER; DIBENZAZEPINES; FEMALE; HUMANS; LONGITUDINAL STUDIES; MALE; MIDDLE AGED; RETROSPECTIVE STUDIES; SEIZURES; STATISTICS, NONPARAMETRIC; TIME FACTORS; VOLTAGE-GATED SODIUM CHANNEL BLOCKERS; YOUNG ADULT;

EID: 84904728186     PISSN: 09201211     EISSN: 18726844     Source Type: Journal    
DOI: 10.1016/j.eplepsyres.2014.04.014     Document Type: Article

References (33)

1. Abou-Khalil B., Rogin J.B., Biraben A., Galimberti C., Kowacs P., Hong S.B., Blum D., Nunes T., Soares da Silva P., Grinnell T., Cheng H. Eslicarbazepine acetate as adjunctive therapy in patients with refractory partial-onset seizures: safety results of a 12-week randomized placebo-controlled study [poster]. 67th Annual Meeting of the American Epilepsy Society 2013, 128. on behalf of the 304 Study Team.
2. Almeida L., Bialer M., Soares-da-Silva P. Eslicarbazepine acetate. The Treatment of Epilepsy 2009, 485-498. Wiley-Blackwell, Oxford, UK. third ed. S. Shorvon, E. Perucca, J. Engel (Eds.).
3. Arzimanoglou A., Ben-Menachem E., Cramer J., Glauser T., Seeruthun R., Harrison M. The evolution of antiepileptic drug development and regulation. Epileptic Disord. 2010, 12:3-15.
4. Bancaud J., Henriksen O., Rubio-Donnadieu F., Seino M., Dreifuss F.E., Penry J.K. Commission on classification and terminology of the international league against epilepsy. Proposal for revised clinical and electroencephalographic classification of epileptic seizures. Epilepsia 1981, 22:489-501.
5. Berg A.T., Berkovic S.F., Brodie M.J., Buchhalter J., Cross J.H., van Emde Boas W., Engel J., French J., Glauser T.A., Mathern G.W., Moshé S.L., Nordli D., Plouin P., Scheffer I.E. Revised terminology and concepts for organization of seizures and epilepsies: report of the ILAE Commission on Classification and Terminology, 2005-2009. Epilepsia 2010, 51:676-685.
6. Beghi E., Messina P., Pupillo E., Crichiutti G., Baglietto M.G., Veggiotti P., Zamponi N., Casellato S., Margari L., Cianchetti C. Satisfaction with antiepileptic drugs in children and adolescents with newly diagnosed and chronic epilepsy. Epilepsy Res. 2012, 100:142-151.
7. Benes J., Parada A., Figueiredo A.A., Alves P.C., Freitas A.P., Learmonth D.A., Cunha R.A., Garrett J., Soares-da-Silva P. Anticonvulsant and sodium channel-blocking properties of novel 10,11-dihydro-5H-dibenz[b,f]azepine-5-carboxamide derivatives. J. Med. Chem. 1999, 42:2582-2587.
8. Ben-Menachem E., Gabbai A.A., Hufnagel A., Maia J., Almeida L., Soares-da-Silva P. Eslicarbazepine acetate as adjunctive therapy in adult patients with partial epilepsy. Epilepsy Res. 2010, 89:278-285.
9. 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, 50:454-463.
10. Faught E. Adherence to antiepilepsy drug therapy. Epilepsy Behav. 2012, 25:297-302.
11. Faught R.E., Weiner J.R., Guerin A., Cunnington M.C., Duh M.S. Impact of nonadherence to antiepileptic drugs on health care utilization and costs: findings from the RANSOM study. Epilepsia 2009, 50:501-509.
12. French J.A., Kanner A.M., Bautista J., Abou-Khalil B., Browne T., Harden C.L., Theodore W.H., Bazil C., Stern J., Schachter S.C., Bergen D., Hirtz D., Montouris G.D., Nespeca M., Gidal B., Marks W.J., Turk W.R., Fischer J.H., Bourgeois B., Wilner A., Faught R.E., Sachdeo R.C., Beydoun A., Glauser T.A. Efficacy and tolerability of the new antiepileptic drugs II: treatment of refractory epilepsy: report of the Therapeutics and Technology Assessment Subcommittee and Quality Standards Subcommittee of the American Academy of Neurology and the American Epilepsy Society. Neurology 2004, 62:1261-1273.
13. French J.A. Refractory epilepsy: clinical overview. Epilepsia 2007, 48(Suppl. 1):3-7.
14. Gil-Nagel A., Elger C., Ben-Menachem E., Halasz P., Lopes-Lima J., Gabbai A.A., Nunes T., Falcao A., Almeida L., da-Silva P.S. Efficacy and safety of eslicarbazepine acetate as add-on treatment in patients with focal-onset seizures: integrated analysis of pooled data from double-blind phase III clinical studies. Epilepsia 2013, 54:98-107.
15. Gil-Nagel A., Lopes-Lima J., Almeida L., Maia J., Soares-da-Silva P. Efficacy and safety of 800 and 1200mg eslicarbazepine acetate as adjunctive treatment in adults with refractory partial-onset seizures. Acta Neurol. Scand. 2009, 120:281-287.
16. Halasz P., Cramer J., Hodoba D., Członkowska A., Guekht A., Maia J., Elger C., Almeida L., Soares-da-Silva P. Long-term efficacy and safety of eslicarbazepine acetate: results of a 1-year open-label extension study in partial-onset seizures in adults with epilepsy. Epilepsia 2010, 51:1963-1969.
17. Hebeisen S., Brady K., Konrad D., Soares-da-Silva P. Inhibitory effects of eslicarbazepine acetate and its metabolites against neuronal voltage-gated sodium channels. Epilepsia 2011, 52:257-258. [abstract].
18. Hesdorffer D.C., Logroscino G., Benn E.K., Katri N., Cascino G., Hauser W.A. Estimating risk for developing epilepsy: a population-based study in Rochester, Minnesota. Neurology 2011, 76:23-27.
19. Hufnagel A., Ben-Menachem E., Gabbai A.A., Falcao A., Almeida L., Soares-da-Silva P. Long-term safety and efficacy of eslicarbazepine acetate as adjunctive therapy in the treatment of partial-onset seizures in adults with epilepsy: results of a 1-year open-label extension study. Epilepsy Res. 2013, 103:262-269.
20. Knoester P.D., Keyser A., Renier W.O., Egberts A.C., Hekster Y.A., Deckers C.L. Effectiveness of lamotrigine in clinical practice: results of a retrospective population-based study. Epilepsy Res. 2005, 65:93-100.
21. Kwan P., Schachter S.C., Brodie M.J. Drug-resistant epilepsy. N. Engl. J. Med. 2011, 365:919-926.
22. Massot A., Vivanco R., Principe A., Roquer J., Rocamora R. Post-authorisation study of eslicarbazepine as treatment for drug-resistant epilepsy: preliminary results. Neurologia 2013, (in Spanish) (epub ahead of print).
23. Mattson R.H., Cramer J.A., Collins J.F. A comparison of valproate with carbamazepine for the treatment of complex partial seizures and secondarily generalized tonic-clonic seizures in adults. The Department of Veterans Affairs Epilepsy Cooperative Study No. 264 Group. N. Engl. J. Med. 1992, 327:765-771.
24. Serrano-Castro P.J., Payan-Ortiz M., Cimadevilla J.M., Quiroga-Subirana P., Fernandez-Perez J. Eslicarbazepine acetate in clinical practice. Efficacy and safety results. Rev. Neurol. 2013, 56:309-314. [in Spanish].
25. Shorvon S. Oxcarbazepine: a review. Seizure 2000, 9:75-79.
26. Soares-da-Silva P., Hebeisen S. Slow and fast inactivation of voltage-gated sodium channels by eslicarbazepine and carbamazepine. Epilepsia 2012, 53:54. [abstract].
27. Sperling M., Harvey J., Biraben A., Galimberti C., Kowacs P., Hong S.B., Cheng H., Blum D., Nunes T., Soares da Silva P. Adjunctive eslicarbazepine acetate in patients with refractory partial-onset seizures: efficacy results of a 12 week randomized placebo-controlled study [poster]. 67th Annual Meeting of the American Epilepsy Society 2013, 210. on behalf of the 304 Study Team.
28. Steinhoff B.J., Trinka E., Wendling A.S. Abrupt switch from extended-release oxcarbazepine to eslicarbazepine acetate. Nervenarzt 2011, 82:764-767. [in German].
29. Stephen L.J., Kelly K., Wilson E.A., Parker P., Brodie M.J. A prospective audit of adjunctive zonisamide in an everyday clinical setting. Epilepsy Behav. 2010, 17:455-460.
30. Tomson T., Nashef L., Ryvlin P. Sudden unexpected death in epilepsy: current knowledge and future directions. Lancet Neurol. 2008, 7:1021-1031.
31. Villanueva V., Lopez-Gomariz E., Lopez-Trigo J., Palau J., Garcia M., Villarroya T., Bonet M., Santafe C. Rational polytherapy with lacosamide in clinical practice: results of a Spanish cohort analysis RELACOVA. Epilepsy Behav. 2012, 23:298-304.
32. Witt J.A., Elger C.E., Helmstaedter C. Which drug-induced side effects would be tolerated in the prospect of seizure control?. Epilepsy Behav. 2013, 29:141-143.
33. Zaccara G., Giovannelli F., Maratea D., Fadda V., Verrotti A. Neurological adverse events of new generation sodium blocker antiepileptic drugs Meta-analysis of randomized, double-blinded studies with eslicarbazepine acetate, lacosamide and oxcarbazepine. Seizure 2013, 22:528-536.