Two-year follow-up with eslicarbazepine acetate: a consecutive, retrospective, observational study

Correia, Fernando Dias; Freitas, Joel; Magalhães, Rui; Lopes, João; Ramalheira, João; Lopes-Lima, J.; Chaves, João

doi:10.1016/j.eplepsyres.2014.06.017

Cited by 30 publications

(43 citation statements)

References 15 publications

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“…These results might be explained by the fact that EPOS population seemed to be less refractory in comparison to our study, as suggested by a shorter mean time since epilepsy diagnosis (12.3±12.1 years in EPOS19 vs 18.5±14.8 years in this study). On the other hand, the responder rate attained in this study is significantly higher than the ones reported in the 1‐year and 2‐year retrospective studies16, 18 at 6 months (57.9% and 25.7%, respectively). Two main reasons might be responsible for these differences.…”

Section: Discussioncontrasting

confidence: 80%

“…vs median of 16.0 years in this study; mean of 26.8±13.1 years in Correia et al 16. vs mean of 18.5±14.8 years in this study) and the number of baseline AEDs used (patients used up to five and six AEDs at baseline in Correia et al 16. and Villanueva et al.,18 respectively, vs only one baseline AED in this study).…”

Section: Discussionmentioning

confidence: 49%

“…Second, the patients included in the two retrospective studies were more refractory than the ESLADOBA population, as reflected by longer times since epilepsy diagnosis (median of 19.0 years in Villanueva et al 18. vs median of 16.0 years in this study; mean of 26.8±13.1 years in Correia et al 16. vs mean of 18.5±14.8 years in this study) and the number of baseline AEDs used (patients used up to five and six AEDs at baseline in Correia et al 16.…”

Section: Discussionmentioning

confidence: 72%

“…The primary endpoint of the study was RR, which is of utmost importance in the analysis of long‐term AED treatments as it reflects the complex interactions between efficacy and tolerability 16. This study showed RR of 73.0% at the Vfinal.…”

Section: Discussionmentioning

confidence: 85%

“…This study showed RR of 73.0% at the Vfinal. At 6 months, higher RR was found in a similar non‐interventional prospective study (EPOS)17 (82.2%), in a 1‐year retrospective study18 (80.1%), and in a 2‐year retrospective study16 (82.9%). The lower RR obtained in this study may be due to an underestimation, as a worst scenario was used by classifying those patients that did not perform the final assessment as failures.…”

Section: Discussionmentioning

confidence: 89%

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Eslicarbazepine acetate as adjunctive therapy in clinical practice: ESLADOBA study

Chaves¹,

Breia

Pimentel

et al. 2017

Acta Neurol Scand

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ObjectiveTo 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.MethodsMulticenter, 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.ResultsFifty‐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.ConclusionsEslicarbazepine acetate showed good retention rates, elicited a significant reduction in seizure frequency, and was well tolerated when used in the clinical practice.

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Section: Discussioncontrasting

confidence: 80%

Section: Discussionmentioning

confidence: 49%

Section: Discussionmentioning

confidence: 72%

Section: Discussionmentioning

confidence: 85%

Section: Discussionmentioning

confidence: 89%

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Eslicarbazepine acetate as adjunctive therapy in clinical practice: ESLADOBA study

Chaves¹,

Breia

Pimentel

et al. 2017

Acta Neurol Scand

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Eslicarbazepine acetate: its effectiveness as adjunctive therapy in clinical trials and open studies

et al. 2017

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Eslicarbazepine acetate (ESL) is a once-daily antiepileptic drug that is approved as adjunctive therapy in adults with focal-onset seizures. Following oral administration, ESL is rapidly metabolized to its active metabolite, eslicarbazepine, which acts primarily by enhancing slow inactivation of voltage-gated sodium channels. The efficacy and safety/tolerability of ESL in the adjunctive setting were established in a comprehensive Phase III program (n = 1702 randomized patients) and this evidence has been supported by several open studies (n = 864). ESL treatment has demonstrated improvements in health-related quality of life, in both randomized clinical trials and open studies. ESL has also been shown to be usually well tolerated and efficacious when used in the adjunctive setting in elderly patients. The effectiveness of ESL as the only add-on to antiepileptic drug monotherapy has been demonstrated in a multinational study (n = 219), subgroup analyses of which have also shown it to be efficacious and generally well tolerated in patients who had previously not responded to carbamazepine therapy. Open studies have also demonstrated improvements in tolerability in patients switched overnight from oxcarbazepine to ESL. Due to differences in pharmacokinetics, pharmacodynamics, and metabolism, there may be clinical situations in which it is appropriate to consider switching patients from oxcarbazepine or carbamazepine to ESL.

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Euro-Esli: a European audit of real-world use of eslicarbazepine acetate as a treatment for partial-onset seizures

et al. 2017

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The Euro-Esli study was an exploratory pooled analysis of data from 14 European clinical practice studies, which was conducted to audit the real-world effectiveness, safety, and tolerability of eslicarbazepine acetate (ESL) as an adjunctive treatment for partial-onset seizures. Retention and effectiveness were assessed after 3, 6, and 12 months of ESL treatment, and at the final visit. Safety and tolerability were assessed throughout ESL treatment by evaluating adverse events (AEs) and ESL discontinuation due to AEs. Data from 2058 patients (52.1% male; mean age 44.0 years) were included. All 2058 patients were assessed for safety and 1975 (96.0%) patients were assessed for effectiveness. After 12 months, retention, responder (≥50% seizure frequency reduction), and seizure freedom rates were 73.4, 75.6, and 41.3%, respectively. AEs were reported for 34.0% of patients and led to discontinuation in 13.6% of patients. The most frequently reported AEs were dizziness (6.7% of patients), fatigue (5.4%), and somnolence (5.1%). No unexpected safety signals emerged over a median duration of follow-up of >5 years. Subgroup analyses revealed that ESL was significantly more effective in patients aged ≥65 versus <65 years, in patients who were not receiving treatment with other sodium channel blockers versus those who were receiving treatment with other sodium channel blockers, and in patients who were receiving <2 versus ≥2 concomitant antiepileptic drugs at baseline. Euro-Esli is the largest ESL clinical practice study conducted to date. This study provides strong and reassuring evidence of ESL’s safety profile, and complements the data from clinical trials.

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Two-year follow-up with eslicarbazepine acetate: a consecutive, retrospective, observational study

Cited by 30 publications

References 15 publications

Eslicarbazepine acetate as adjunctive therapy in clinical practice: ESLADOBA study

Eslicarbazepine acetate as adjunctive therapy in clinical practice: ESLADOBA study

Eslicarbazepine acetate: its effectiveness as adjunctive therapy in clinical trials and open studies

Euro-Esli: a European audit of real-world use of eslicarbazepine acetate as a treatment for partial-onset seizures

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