The ROME (Retrospective Observational Multicenter study on Eslicarbazepine) study: Efficacy and behavioural effects of Eslicarbazepine acetate as adjunctive therapy for adults with partial onset seizures in real life

Assenza, Giovanni; Mecarelli, Oriano; Lanzone, Jacopo; Assenza, Federica; Tombini, Mario; Lazzaro, Vincenzo Di; Pulitano, Patrizia

doi:10.1016/j.seizure.2018.03.028

Cited by 10 publications

(9 citation statements)

References 22 publications

(33 reference statements)

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“…The Euro-Esli study was an exploratory, retrospective, pooled analysis of data from European clinical practice studies, [9][10][11][12][13][14][15][16][17][18][19][20][21] conducted to audit the effectiveness, safety, and tolerability of ESL as an adjunctive treatment for focal-onset seizures in clinical practice, details of which have been published previously. 8 In brief, effectiveness was assessed after 3, 6, and 12 months of ESL treatment and at final follow-up, and safety and tolerability were assessed for the duration of ESL treatment.…”

Section: Methodsmentioning

confidence: 99%

Eslicarbazepine acetate as monotherapy in clinical practice: Outcomes from Euro-Esli

et al. 2018

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Section: Methodsmentioning

confidence: 99%

Eslicarbazepine acetate as monotherapy in clinical practice: Outcomes from Euro-Esli

et al. 2018

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“…18 However, some AEDs have been clearly related to an increased rate of aggression, which particularly impacts on patients with psychiatric comorbidities. 19,20 The ESL precursors, carbamazepine and oxcarbazepine, rarely have shown drug-related behavioral adverse events. However, in the absence of seizure frequency reduction, still ESL patients improved their anger levels, proving a favorable psychiatric profile of the drug in focal onset epilepsies with preserved cognitive function.…”

Section: Discussionmentioning

confidence: 99%

“…However, in the absence of seizure frequency reduction, still ESL patients improved their anger levels, proving a favorable psychiatric profile of the drug in focal onset epilepsies with preserved cognitive function. 19,20 The ESL precursors, carbamazepine and oxcarbazepine, rarely have shown drug-related behavioral adverse events. 21,22 They are even considered a good choice to control aggression in psychiatric patients.…”

Section: Discussionmentioning

confidence: 99%

Levels of anger in epilepsy patients treated with eslicarbazepine acetate

et al. 2019

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Introduction: Aggressive behavior is commonly associated with epilepsy and can be influenced by the antiepileptic drugs (AEDs) taken. Sodium channel blockers, specifically the carboxamides derivatives such as carbamazepine and oxcarbazepine, are some of the AEDs considered to have a favorable psychiatric effect profile. Objectives:We aimed to assess whether the carboxamide analogue eslicarbazepine acetate (ESL) has any effect on the levels of anger in patients with epilepsy. Material and methods:We prospectively recruited adult patients with epilepsy on treatment with ≦2 active AEDs, who required AED addition or substitution, excluding patients with active psychiatric disorders. All patients completed anger level (STAXI-2), depression-anxiety (HADS), and quality of life (QOLIE-10) assessments, and were evaluated at baseline and within 3-6 months after treatment initiation. Results:Of 78 patients receiving ESL, as add-on therapy or in substitution of a previous AED, were recruited into the ESL group, with an average age of 48 years and 54% men.We used a control group of 58 patients receiving AEDs other than carboxamides. Conclusions:Patients overall showed improvements in anger levels, mood, and quality of life during the follow-up. A history of psychiatric disorders was a limiting factor to improve anger levels. As compared to controls, anger levels improved in ESL patients independently from seizure control. Therefore, ESL seems to exert a favorable influence on the anger levels of otherwise healthy patients with epilepsy, including those unresponsive to seizure control. The potential ESL anti-aggressive effect should be studied in patients with epilepsy and active psychiatric disorders. K E Y W O R D Saggressive behavior, anger, antiepileptic drugs, behavioral disorders, carboxamides, epilepsy, eslicarbazepine acetate, psychiatric adverse events | INTRODUC TI ON | BackgroundBetween 15% and 20% of adult patients with epilepsy taking antiepileptic drugs (AEDs) experience behavioral adverse events, which include depressive mood, psychosis, increase in irritability, and aggressive behavior. 1 Aggression and related behaviors encompass terms such as agitation, anger, hostility, impulsivity, or irritability. 2,3 The lack of knowledge of the true prevalence and risk factors of behavioral disorders in patients with epilepsy is striking. 4

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“…Details of the specific inclusion/exclusion criteria used in the individual studies have been published or presented previously [22,[25][26][27][28][29][30][31][32][33][34][35][36][37]. As these were real-world studies, there were generally few inclusion/exclusion criteria, in order to be more representative of the variety of patients encountered in clinical practice.…”

Section: Study Populationmentioning

confidence: 99%

Safety, tolerability and effectiveness of transition to eslicarbazepine acetate from carbamazepine or oxcarbazepine in clinical practice

Rocamora

Peltola

Assenza

et al. 2020

Seizure

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To assess the efficacy, safety and tolerability of eslicarbazepine acetate (ESL) in patients transitioning from carbamazepine or oxcarbazepine to ESL in clinical practice, by analysing data from the Euro-Esli study. Methods: Euro-Esli was a pooled analysis of 14 European clinical practice studies. Effectiveness assessments included responder rate (≥50 % seizure frequency reduction) and seizure freedom rate (seizure freedom at least since prior visit), assessed after 3, 6 and 12 months of ESL treatment, and at the last visit. Safety and tolerability were assessed throughout follow-up by evaluating adverse events (AEs) and ESL discontinuation due to AEs, respectively. Data were analysed for cohorts of patients who transitioned from carbamazepine and oxcarbazepine to ESL either due to lack of efficacy or poor tolerability. Results: Euro-Esli included 2058 patients, of whom 233 (11.3 %) transitioned from carbamazepine to ESL and 134 (6.5 %) transitioned from oxcarbazepine to ESL. After 12 months of ESL treatment, responder and seizure freedom rates for patients transitioning from carbamazepine due to lack of efficacy (n = 163) were 70.0 % and 30.9 %, respectively. Corresponding values for patients transitioning from oxcarbazepine due to lack of efficacy (n = 90) were 57.1 % and 25.0 %, respectively. Among patients who transitioned from carbamazepine and oxcarbazepine to ESL due to poor tolerability (n = 64 and n = 61, respectively), 26.6 % and 39.5 % experienced AEs, and 8.3 % and 6.8 % discontinued ESL due to AEs, respectively. Conclusion: ESL was efficacious and generally well tolerated in patients transitioning from carbamazepine or oxcarbazepine in clinical practice due to inadequate seizure control or intolerable AEs with these agents.

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The ROME (Retrospective Observational Multicenter study on Eslicarbazepine) study: Efficacy and behavioural effects of Eslicarbazepine acetate as adjunctive therapy for adults with partial onset seizures in real life

Abstract: ESL is a safe and effective anti-epileptic drug in a real life scenario, with an excellent behavioural profile for the overall quality of life and, in particular, for sleepiness and depression.

Cited by 10 publications

References 22 publications

Eslicarbazepine acetate as monotherapy in clinical practice: Outcomes from Euro-Esli

Eslicarbazepine acetate as monotherapy in clinical practice: Outcomes from Euro-Esli

Levels of anger in epilepsy patients treated with eslicarbazepine acetate

Safety, tolerability and effectiveness of transition to eslicarbazepine acetate from carbamazepine or oxcarbazepine in clinical practice

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