Eslicarbazepine acetate as adjunctive therapy in clinical practice: ESLADOBA study.
OBJECTIVE
To assess seizure control and tolerability of eslicarbazepine acetate (ESL) as adjunctive therapy to one baseline antiepileptic drug (AED), in adults with partial-onset seizures (POS) with or without secondary generalization.


METHODS
Multicenter, non-interventional, prospective cohort study conducted between March 2012 and September 2014 at 12 neurology departments in Portugal. Adults with POS not controlled with one AED who had initiated ESL as adjunctive treatment were enrolled. Retention rate was defined at the final visit (Vfinal) 6-9 months of follow-up. Proportion of responders, seizure-free, changes in seizure frequency were evaluated using patients' diaries. Clinical Global Impression of Change (CGI-C) and Clinical Global Impression of Severity (CGI-S) were assessed by the neurologist.


RESULTS
Fifty-two patients (48.1% male) were included with mean age 41.5±13.3 years. Mean epilepsy duration was 18.5±14.8 years; mean seizure frequency in the four previous weeks to baseline was 7.5±12.7. At Vfinal, retention rate was 73.0%; responder rate and seizure-free rates were 71.1% and 39.5%, respectively. The median relative reduction in seizure frequency between baseline and Vfinal was 82.2%. A reduction in epilepsy severity (CGI-S) was observed in 42.1%. According to CGI-C, 73.6% patients had their epilepsy "much improved" or "very much improved". Twelve patients (23.1%) had at least one adverse event (AE), two (3.9%) had one serious AE, and five (9.6%) discontinued due to AE.


CONCLUSIONS
Eslicarbazepine acetate showed good retention rates, elicited a significant reduction in seizure frequency, and was well tolerated when used in the clinical practice.
Department of Neurology, Hospital Santo António, Centro Hospitalar Porto, Porto, Portugal.
J
J
Chaves
Department of Neurology, Hospital Garcia de Orta, Almada, Portugal.
P
P
Breia
Department of Neurosciences, Hospital de Santa Maria, Centro Hospitalar Lisboa Norte, Lisbon, Portugal.|Faculty of Medicine of Lisbon University, Lisbon, Portugal.
J
J
Pimentel
Department of Neurology, Hospital de Egas Moniz, Centro Hospitalar de Lisboa Ocidental, Lisbon, Portugal.
R
R
Pelejão
Department of Neurology, Centro Hospitalar São João, Porto, Portugal.|Faculty of Medicine of Porto University, Porto, Portugal.
M
M
Carvalho
Department of Neurology, Hospital de Santo André, Centro Hospitalar de Leiria, Leiria, Portugal.
P
P
Mateus
Department of Neurology, Hospital de S. Sebastião, Centro Hospitalar de Entre o Douro e Vouga, Santa Maria da Feira, Portugal.
H
H
Grebe
Department of Neurology, Clinicoimbra, Coimbra, Portugal.
A
A
Mestre
Department of Research and Development, BIAL, Coronado, Portugal.
H
http://orcid.org/0000-0003-0898-932X
H
Fernandes
Department of Research and Development, BIAL, Coronado, Portugal.
R
R
Sousa
Department of Research and Development, BIAL, Coronado, Portugal.
A
A
Gala
D000328:Adult; D000927:Anticonvulsants / Q000009:adverse effects / Q000627:therapeutic use*; D003984:Dibenzazepines / Q000009:adverse effects / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D004828:Epilepsies, Partial / Q000188:drug therapy*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D016896:Treatment Outcome
D000927:Anticonvulsants; D003984:Dibenzazepines; C416835:eslicarbazepine acetate
adjunctive therapy; adults; eslicarbazepine acetate; partial seizures; refractory epilepsy; retention rate