Efficacy and safety of eslicarbazepine-acetate in elderly patients with focal epilepsy: Case series

Gómez‐Ibáñez, Asier; Serratosa, Joan; Guillamón, Edelmira; Garcés, Mercedes; Giráldez, Beatriz G.; Toledo, Manuel; Salas-Puig, Javier; López‐González, Francisco Javier; Rodríguez-Uranga, J.; Castillo, Agustín Diez; Camacho, J.L.; López-Gomáriz, Elena; Giner, P.; Torres, Nicolás; Palau, Juan; Molins, A; Villanueva, Vicente

doi:10.1016/j.seizure.2017.04.003

Cited by 13 publications

(10 citation statements)

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“…The efficacy results were consistent with known previous data on ESL obtained from the phase III pivotal population [ 14 ]. With regards to other adjunctive ESL studies, an analysis of patients aged > 65 years included within the ESLIBASE study showed that, at 6 months, 24.1% of elderly patients were seizure free, similarly to our findings [ 20 ]. It is also similar to a retrospective open-label study of zonisamide as monotherapy/add-on treatment in focal and primary generalized epilepsy stratified by age, where seizure freedom was achieved in 27% of elderly patients, although 36% of the elderly epileptic patients received monotherapy, and were less refractory patients [ 21 ].…”

Section: Discussionsupporting

confidence: 88%

Safety, Tolerability and Efficacy of Eslicarbazepine Acetate as Adjunctive Therapy in Patients Aged ≥ 65 Years with Focal Seizures

et al. 2018

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BackgroundThe incidence of epilepsy is high within the first few years of life, stabilizes over the second through fifth decades, and then rises again. Treatment of elderly patients with antiepileptic drugs (AEDs) is complicated by increased sensitivity to drug effects, altered pharmacokinetics and an increased risk for drug interactions due to polytherapy. On the other hand, the safety and efficacy data of AEDs attained during clinical development programmes are relatively limited for this age group.ObjectiveThe aim of this study was to evaluate the safety, tolerability and efficacy of eslicarbazepine acetate (ESL) as adjunctive therapy in patients aged ≥ 65 years with focal-onset seizures (FOS).MethodsThis was an international, multicentre, open-label, non-controlled, single-arm, post-European approval commitment study with flexible doses of ESL between 400 and 1200 mg/day. Seventy-two elderly patients with at least two FOS in the prior 4 weeks, and treated with one or two AEDs, were enrolled. The study consisted of an 8-week baseline, followed by a 26-week treatment period during which the investigator was allowed to up- or down-titrate the ESL dose, and a 4-week follow-up period. Safety and tolerability were assessed as well as mental sedation, cognitive mental state and suicidal ideation. Efficacy was assessed based on patient diaries regarding the absolute and relative changes in seizure frequency, change in intellectual impairment and quality of life.ResultsOverall, 47 (65.3%) patients experienced 152 treatment-emergent adverse events (TEAEs). The most frequent were dizziness (12.5%), somnolence (9.7%), fatigue, convulsion and hyponatraemia (8.3% each). All patients that experienced hyponatraemia (6/72) recovered without sequelae. Three patients died during the study (due to cardiac failure, glioblastoma multiforme and ischaemic stroke, all considered unrelated to ESL). Overall, 16 (22.2%) patients discontinued prematurely due to TEAEs. The incidences of clinically significant findings were low for vital signs, ECG, physical and neurological examinations. No TEAEs of hypothyroidism were reported; however, 24 (33.3%) patients presented post-baseline shifts from normal to decreased free T4 levels (not clinically significant). ESL decreased standardized seizure frequency from a mean of 4.8 seizures at baseline to 3.6 seizures at endpoint (p > 0.05); and mean number of days with seizures significantly decreased from 4.1 (baseline) to 2.8 at endpoint (p = 0.0408).ConclusionESL taken once daily (400–1200 mg) as adjunctive therapy in patients aged ≥ 65 years was found to be safe, well tolerated and efficacious (EudraCT number: 2009-012587-14).Electronic supplementary materialThe online version of this article (10.1007/s40266-018-0602-y) contains supplementary material, which is available to authorized users.

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Section: Discussionsupporting

confidence: 88%

Safety, Tolerability and Efficacy of Eslicarbazepine Acetate as Adjunctive Therapy in Patients Aged ≥ 65 Years with Focal Seizures

et al. 2018

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“…To our knowledge, clinical experience with ESL monotherapy in elderly patients has not been reported but ESL add‐on therapy has been reported to show better efficacy but more adverse effects in elderly than in younger patients (<65 years), despite the use of lower mean daily doses . Similarly, in the current study we found high seizure‐free rates at all the evaluation periods, with 67.3% of patients being seizure free for the entire follow‐up (vs 55.3% in the total population), the 1‐year retention rate was slightly lower (72.7%), and adverse events were more frequent (39.3%) in the elderly despite lower mean doses of ESL (720 mg/d at 12 months vs 879.3 mg/d in the total population).…”

Section: Discussionsupporting

confidence: 58%

Clinical outcomes of eslicarbazepine acetate monotherapy for focal‐onset seizures: A multicenter audit

et al. 2019

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Objective To assess the effectiveness and tolerability of eslicarbazepine acetate (ESL) monotherapy in routine clinical practice for the treatment of focal‐onset seizures. Methods Multicenter, retrospective, observational study conducted in patients older than 16 years treated with ESL as first‐line monotherapy or converted to ESL monotherapy from polytherapy or other monotherapy. Outcomes included 1‐year retention rate, seizure‐free rates after 6 and 12 months of monotherapy treatment, and safety/tolerability issues. Results A total of 256 patients were included (106 first‐line and 150 conversion to monotherapy; 56 patients aged >65 years). Overall, the 1‐year retention rate was 79% (72.7% in the ≥65 years subgroup) and seizure‐free rates at 6 and 12 months were 59.3% and 55.3% (72.2% and 67.3% in the ≥65 years subgroup), without significant differences when comparing first‐line vs conversion‐to‐ESL monotherapy groups (P = .979). However, the conversion group was heterogeneous and included 43 (29.1%) patients that were seizure free the year prior ESL introduction. A substantially higher proportion of patients remained seizure free for the entire follow‐up among those who initiated ESL due to tolerability problems compared with those treated due to inadequate seizure control (71.4% vs 37.3%). Overall, 62 of 256 (24.2%) patients reported AEs (39.3% in >65 years subgroup) and led to discontinuation in 20/256 (7.8%) patients (12.5% in >65 years subgroup). Commonly reported AEs were somnolence (6.6%), dizziness (6.3%), and headache (4.3%). Hyponatremia was recorded in five patients, the majority (4/5) of whom were older than 65 years. Conclusions Eslicarbazepine acetate was effective and well‐tolerated as first‐line or conversion to monotherapy in a clinical setting in adult and elderly patients with focal‐onset seizures.

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“…In addition, hyponatremia resolved (from 128 to 138 mmol/L) in one patient and remained the same (133 mmol/L) in another patient after transitioning from OXC to ESL [ 32 ]. In a multicenter, retrospective case series of 29 elderly patients (> 65 years) with focal seizures who were treated with ESL, the tolerability profile improved in four of five patients who transitioned from CBZ or OXC to ESL because of AEs [ 36 ]. Overall, 3/29 (10.3%) patients developed hyponatremia, but only one developed symptoms (confusion) that resolved after withdrawal of ESL [ 36 ].…”

Section: Tolerability Profiles: Do These Differ?mentioning

confidence: 99%

“…In clinical trials of ESL adjunctive therapy, treatment regimens that included CBZ were shown to be less well tolerated than those that did not, despite attaining clinical efficacy [ 30 ]. There is also considerable evidence to demonstrate that patients transitioning from OXC or CBZ to ESL because of AEs experience improvements in tolerability [ 31 – 36 ]. Interestingly, improvements in quality of life and/or alertness were also reported [ 35 ].…”

Section: Tolerability Profiles: Do These Differ?mentioning

confidence: 99%

Dibenzazepine Agents in Epilepsy: How Does Eslicarbazepine Acetate Differ?

et al. 2018

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Carbamazepine (CBZ), oxcarbazepine (OXC), and eslicarbazepine acetate (ESL) belong to the dibenzazepine family of antiepileptic drugs and are all thought to primarily act as sodium channel blockers (SCBs). However, ESL is structurally distinct from CBZ and OXC, resulting in differences in metabolism, pharmacokinetics, and pharmacodynamics. Despite a lack of direct comparative data, evidence for potential differences in effectiveness and tolerability within the dibenzazepine family has emerged from studies in which patients being treated with one dibenzazepine agent have received adjunctive treatment with another (having achieved insufficient seizure control with the first) or have transitioned from one dibenzazepine agent to another because of lack of effectiveness or poor tolerability. Most of these studies have been conducted in the real-world clinical practice setting. ESL has been shown to be effective as adjunctive therapy in patients who have previously achieved inadequate seizure control with CBZ, indicating that the use of different dibenzazepine agents in combination can provide additive effectiveness benefits, which may reflect underlying differences in their mechanisms of action. Similarly, ESL monotherapy can be effective in patients who have switched from another dibenzazepine, such as CBZ or OXC, because of inadequate efficacy. There is also considerable evidence to demonstrate that patients transitioning from OXC or CBZ to ESL as a result of adverse events experience improvements in tolerability, which may also be associated with improvements in quality of life, alertness, and/or lipid profiles. Current evidence therefore demonstrates that ESL differs from other dibenzazepine agents in terms of effectiveness and tolerability.Funding: Eisai Ltd.

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Efficacy and safety of eslicarbazepine-acetate in elderly patients with focal epilepsy: Case series

Abstract: ESL was well-tolerated and effective in elderly patients in a real-life setting over 1year, with a dose around 800mg/day. AE effects improved in most of who switched from CBZ or OXC to ESL.

Cited by 13 publications

References 10 publications

Safety, Tolerability and Efficacy of Eslicarbazepine Acetate as Adjunctive Therapy in Patients Aged ≥ 65 Years with Focal Seizures

Safety, Tolerability and Efficacy of Eslicarbazepine Acetate as Adjunctive Therapy in Patients Aged ≥ 65 Years with Focal Seizures

Clinical outcomes of eslicarbazepine acetate monotherapy for focal‐onset seizures: A multicenter audit

Dibenzazepine Agents in Epilepsy: How Does Eslicarbazepine Acetate Differ?

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