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

P. Halász, Joyce A. Cramer, Danilo Hodoba, Anna Czåonkowska, Alla Guekht, Joana Maia, Christian Elger, Luis Almeida, Patricio Soares-Da-Silva

Research output: Contribution to journalArticle

72 Citations (Scopus)

Abstract

Purpose: To evaluate the long-term efficacy and safety of once daily eslicarbazepine acetate (ESL) as adjunctive therapy for partial-onset seizures in adults with epilepsy. Methods: One-year open-label treatment extension with ESL in patients who completed a placebo-controlled pivotal study (Epilepsia 2009; 50: 454-463). Starting dose was 800 mg once daily, for 4 weeks; thereafter, dose could be titrated up or down. Doses of concomitant antiepileptic drugs were to be kept stable. Results: Overall, 314 patients were enrolled. The intent-to-treat population consisted of 312 patients, and 239 (76.6%) completed 1 year of treatment. ESL median dose was 800 mg once daily. Compared to baseline, median seizure frequency decreased by 39% during the first 4 weeks and between 48% and 56% thereafter. The responder rate (≥50% seizure reduction) was 41% during weeks 1-4 and, thereafter ranged between 48% and 53%. The proportion of seizure-free patients per 12-week interval ranged between 8.7% and 12.5%. Quality of life, as measured by the Quality of Life in Epilepsy Inventory-31 (QOLIE-31), and depressive symptoms, as measured by the Montgomery Asberg Depression Rating Scale (MADRS), improved significantly compared to baseline. Treatment-emergent adverse events (TEAEs) were reported by 51% of patients. The most frequent TEAEs were headache (10%), dizziness (10%), diplopia (5%), and nasopharyngitis (5%). TEAEs were mostly (97%) of mild to moderate intensity. Eleven patients (3.5%) discontinued due to TEAEs. There were no results of laboratory tests raising safety concerns. Discussion: Sustained therapeutic effect, favorable tolerability and safety, and an improvement in quality of life and depressive symptoms were observed during long-term add-on treatment of partial-onset seizures in adults with once daily ESL.

Original languageEnglish
Pages (from-to)1963-1969
Number of pages7
JournalEpilepsia
Volume51
Issue number10
DOIs
Publication statusPublished - Oct 2010

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Epilepsy
Seizures
Safety
Quality of Life
Therapeutics
Depression
Nasopharyngitis
Diplopia
eslicarbazepine acetate
Dizziness
Therapeutic Uses
Anticonvulsants
Headache
Placebos
Equipment and Supplies
Population

Keywords

  • Antiepileptic drugs
  • Epilepsy
  • Eslicarbazepine acetate
  • Long-term treatment
  • Partial-onset seizures
  • Quality of life

ASJC Scopus subject areas

  • Clinical Neurology
  • Neurology

Cite this

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. / Halász, P.; Cramer, Joyce A.; Hodoba, Danilo; Czåonkowska, Anna; Guekht, Alla; Maia, Joana; Elger, Christian; Almeida, Luis; Soares-Da-Silva, Patricio.

In: Epilepsia, Vol. 51, No. 10, 10.2010, p. 1963-1969.

Research output: Contribution to journalArticle

Halász, P, Cramer, JA, Hodoba, D, Czåonkowska, A, Guekht, A, Maia, J, Elger, C, Almeida, L & Soares-Da-Silva, P 2010, '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, vol. 51, no. 10, pp. 1963-1969. https://doi.org/10.1111/j.1528-1167.2010.02660.x
Halász, P. ; Cramer, Joyce A. ; Hodoba, Danilo ; Czåonkowska, Anna ; Guekht, Alla ; Maia, Joana ; Elger, Christian ; Almeida, Luis ; Soares-Da-Silva, Patricio. / 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. In: Epilepsia. 2010 ; Vol. 51, No. 10. pp. 1963-1969.
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abstract = "Purpose: To evaluate the long-term efficacy and safety of once daily eslicarbazepine acetate (ESL) as adjunctive therapy for partial-onset seizures in adults with epilepsy. Methods: One-year open-label treatment extension with ESL in patients who completed a placebo-controlled pivotal study (Epilepsia 2009; 50: 454-463). Starting dose was 800 mg once daily, for 4 weeks; thereafter, dose could be titrated up or down. Doses of concomitant antiepileptic drugs were to be kept stable. Results: Overall, 314 patients were enrolled. The intent-to-treat population consisted of 312 patients, and 239 (76.6{\%}) completed 1 year of treatment. ESL median dose was 800 mg once daily. Compared to baseline, median seizure frequency decreased by 39{\%} during the first 4 weeks and between 48{\%} and 56{\%} thereafter. The responder rate (≥50{\%} seizure reduction) was 41{\%} during weeks 1-4 and, thereafter ranged between 48{\%} and 53{\%}. The proportion of seizure-free patients per 12-week interval ranged between 8.7{\%} and 12.5{\%}. Quality of life, as measured by the Quality of Life in Epilepsy Inventory-31 (QOLIE-31), and depressive symptoms, as measured by the Montgomery Asberg Depression Rating Scale (MADRS), improved significantly compared to baseline. Treatment-emergent adverse events (TEAEs) were reported by 51{\%} of patients. The most frequent TEAEs were headache (10{\%}), dizziness (10{\%}), diplopia (5{\%}), and nasopharyngitis (5{\%}). TEAEs were mostly (97{\%}) of mild to moderate intensity. Eleven patients (3.5{\%}) discontinued due to TEAEs. There were no results of laboratory tests raising safety concerns. Discussion: Sustained therapeutic effect, favorable tolerability and safety, and an improvement in quality of life and depressive symptoms were observed during long-term add-on treatment of partial-onset seizures in adults with once daily ESL.",
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AU - Guekht, Alla

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N2 - Purpose: To evaluate the long-term efficacy and safety of once daily eslicarbazepine acetate (ESL) as adjunctive therapy for partial-onset seizures in adults with epilepsy. Methods: One-year open-label treatment extension with ESL in patients who completed a placebo-controlled pivotal study (Epilepsia 2009; 50: 454-463). Starting dose was 800 mg once daily, for 4 weeks; thereafter, dose could be titrated up or down. Doses of concomitant antiepileptic drugs were to be kept stable. Results: Overall, 314 patients were enrolled. The intent-to-treat population consisted of 312 patients, and 239 (76.6%) completed 1 year of treatment. ESL median dose was 800 mg once daily. Compared to baseline, median seizure frequency decreased by 39% during the first 4 weeks and between 48% and 56% thereafter. The responder rate (≥50% seizure reduction) was 41% during weeks 1-4 and, thereafter ranged between 48% and 53%. The proportion of seizure-free patients per 12-week interval ranged between 8.7% and 12.5%. Quality of life, as measured by the Quality of Life in Epilepsy Inventory-31 (QOLIE-31), and depressive symptoms, as measured by the Montgomery Asberg Depression Rating Scale (MADRS), improved significantly compared to baseline. Treatment-emergent adverse events (TEAEs) were reported by 51% of patients. The most frequent TEAEs were headache (10%), dizziness (10%), diplopia (5%), and nasopharyngitis (5%). TEAEs were mostly (97%) of mild to moderate intensity. Eleven patients (3.5%) discontinued due to TEAEs. There were no results of laboratory tests raising safety concerns. Discussion: Sustained therapeutic effect, favorable tolerability and safety, and an improvement in quality of life and depressive symptoms were observed during long-term add-on treatment of partial-onset seizures in adults with once daily ESL.

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