Safety and Efficacy of Eslicarbazepine Acetate (Zebinix) in Everyday Clinical Practice Using a Retrospective Multicentre Audit

Keogh, Susan; McDonald, Paul; Lawthom, Charlotte; Brodie, MJ; McLean, Brendan; Damodaran, D; Morrow, James; Tittensor, Phil; Bagary, Manny

doi:10.1136/jnnp-2014-309236.67

Cited by 5 publications

(5 citation statements)

References 0 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…Details of the specific inclusion/exclusion criteria used in the individual studies have been published or presented previously [ 17 – 29 ]. The studies included broad inclusion/exclusion criteria, to be representative of the variety of patients encountered in clinical practice.…”

Section: Methodsmentioning

confidence: 99%

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

et al. 2017

View full text Add to dashboard Cite

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.

show abstract

Section: Methodsmentioning

confidence: 99%

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

et al. 2017

View full text Add to dashboard Cite

show abstract

“…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

View full text Add to dashboard Cite

show abstract

“…Study design and patient baseline characteristics for these studies are presented in Table . With the exception of the one multicenter study from Germany and Austria ( N = 281) , most studies have included only small patient populations ( N = 9–74) . Studies varied in length, but most had observation periods of 6 months or more (Table ).…”

Section: Effectiveness Of Perampanel In Real‐world Clinical Settingsmentioning

confidence: 99%

Perampanel for focal epilepsy: insights from early clinical experience

Trinka

Steinhoff

Nikanorova³

et al. 2015

Acta Neurol Scand

View full text Add to dashboard Cite

Perampanel is approved for adjunctive therapy of focal epilepsy with or without secondarily generalized seizures in patients aged >12 years. This narrative review uses real‐world and clinical trial data to elucidate perampanel's role in the clinic. Audit data show good tolerability with perampanel and higher freedom‐from‐seizure rates in elderly vs younger patients. When using perampanel in elderly patients, special attention should be given to comorbidities and co‐medication to avoid potential interactions or adverse events. Slower titration is generally recommended, and seizure control should be reassessed at a dose of 4 mg before further dose increases. Perampanel efficacy is similar in adolescents and adults; however, somnolence, nasopharyngitis, and aggression are more frequent in adolescents vs the overall population. Individualized and slow‐dose titration can minimize adverse events. Low serum concentrations of perampanel may occur in patients also receiving some enzyme‐inducing anti‐epileptic drugs; a perampanel dose increase may be required. Adverse events of importance with perampanel include dizziness; anger, aggression, and hostile behavior (particularly in adolescents); and falls (particularly in patients >65 years). An individualized approach to dosing, including slower up‐titration and bedtime dosing, reduces dizziness risk. Other drugs may cause or aggravate dizziness; reducing concomitant drugs may be necessary when up‐titrating perampanel. It would seem clinically appropriate to give due consideration to avoiding use in patients with a history of anger or hostile/aggressive behavior. The possibility of such behaviors should be discussed with patients before starting perampanel, with monitoring during up‐titration. Slower up‐titration of perampanel in older patients helps reduce fall risk.

show abstract

Safety and Efficacy of Eslicarbazepine Acetate (Zebinix) in Everyday Clinical Practice Using a Retrospective Multicentre Audit

Cited by 5 publications

References 0 publications

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

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

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

Perampanel for focal epilepsy: insights from early clinical experience

Contact Info

Product

Resources

About