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Eslicarbazepine

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21. Efficacy and safety of eslicarbazepine acetate versus controlled-release carbamazepine monotherapy in newly diagnosed epilepsy: A phase III double-blind, randomized, parallel-group, multicenter study. Full Text available with Trip Pro

Efficacy and safety of eslicarbazepine acetate versus controlled-release carbamazepine monotherapy in newly diagnosed epilepsy: A phase III double-blind, randomized, parallel-group, multicenter study. We assessed the efficacy and safety of once-daily eslicarbazepine acetate in comparison with twice-daily (BID) controlled-release carbamazepine (carbamazepine-CR) monotherapy in newly diagnosed focal epilepsy patients.This randomized, double-blind, noninferiority trial (NCT01162460) utilized (...) a stepwise design with 3 dose levels. Patients who remained seizure-free for the 26-week evaluation period (level A: eslicarbazepine acetate 800 mg/carbamazepine-CR 200 mg BID) entered a 6-month maintenance period. If a seizure occurred during the evaluation period, patients were titrated to the next target level (level B: eslicarbazepine acetate 1200 mg/carbamazepine-CR 400 mg BID, level C: eslicarbazepine acetate 1600 mg/carbamazepine-CR 600 mg BID) and the evaluation period began again. The primary

2018 Epilepsia Controlled trial quality: predicted high

22. Assessment of efficacy and safety of eslicarbazepine acetate for the treatment of trigeminal neuralgia. (Abstract)

Assessment of efficacy and safety of eslicarbazepine acetate for the treatment of trigeminal neuralgia. Antiepileptic drugs are the first-line treatment for trigeminal neuralgia (TN). Carbamazepine and oxcarbazepine are the most studied with well-known efficacy. Eslicarbazepine acetate is a third-generation antiepileptic drug that has not previously been evaluated for the treatment of TN. We aim to assess the efficacy, tolerability and safety of eslicarbazepine for TN.Retrospective, open-label (...) , multicentric, intention-to-treat study. We included patients older than 18 years who met the ICHD-3 beta diagnostic criteria for TN. We evaluated the variation of intensity and frequency of pain paroxysms before and after treatment with eslicarbazepine. Secondary objectives assessed were tolerability and safety of eslicarbazepine.Eighteen patients were included, 15 women, mean age 65.2 years old, mean follow-up 21.1 months. The mean number of drugs tested before eslicarbazepine was 2; 10 patients used

2018 European Journal of Pain

23. Safety, Tolerability and Efficacy of Eslicarbazepine Acetate as Adjunctive Therapy in Patients Aged ≥ 65 Years with Focal Seizures. Full Text available with Trip Pro

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

2018 Drugs & Aging

24. Comment on a paper by Sanchez-Larsen A et al. "Assessment of efficacy and safety of eslicarbazepine acetate for the treatment of trigeminal neuralgia". Full Text available with Trip Pro

Comment on a paper by Sanchez-Larsen A et al. "Assessment of efficacy and safety of eslicarbazepine acetate for the treatment of trigeminal neuralgia". 29575409 2018 12 11 2018 12 11 1532-2149 22 6 2018 07 European journal of pain (London, England) Eur J Pain Comment on a paper by Sanchez-Larsen A et al. 'Assessment of efficacy and safety of eslicarbazepine acetate for the treatment of trigeminal neuralgia'. 1188-1189 10.1002/ejp.1219 Alcántara Montero A A Pain Unit, Hospital Don Benito (...) -Villanueva de la Serena, Don Benito (Badajoz), Spain. Sánchez Carnerero C I CI Complejo Hospitalario Universitario de Cáceres, Hospital San Pedro de Alcántara, Cáceres, Spain. eng Letter Comment England Eur J Pain 9801774 1090-3801 0 Dibenzazepines BEA68ZVB2K eslicarbazepine acetate IM Eur J Pain. 2018 Jul;22(6):1080-1087 29369456 Dibenzazepines Humans Trigeminal Neuralgia 2018 03 14 2018 3 27 6 0 2018 12 12 6 0 2018 3 26 6 0 ppublish 29575409 10.1002/ejp.1219

2018 European Journal of Pain

25. Eslicarbazepine acetate in the treatment of adults with partial-onset epilepsy: an evidence-based review of efficacy, safety and place in therapy Full Text available with Trip Pro

Eslicarbazepine acetate in the treatment of adults with partial-onset epilepsy: an evidence-based review of efficacy, safety and place in therapy Up to 30% of the patients diagnosed with epilepsy will continue suffering from seizures despite treatment with antiepileptic drugs, either in monotherapy or polytherapy. Hence, there remains the need to develop new effective and well-tolerated therapies.The objective of this article was to review the evidence for the efficacy and safety (...) of eslicarbazepine acetate (ESL) as adjunctive treatment in adult patients with focal onset seizures.ESL is the newest, third-generation, single enantiomer member of the dibenzazepine family. Following oral administration, ESL is rapidly and extensively metabolized by hepatic first-pass hydrolysis to the active metabolite eslicarbazepine, which has linear, dose-proportional pharmacokinetics and low potential for drug-drug interactions. Eslicarbazepine works as a competitive blocker of the voltage gated sodium

2018 Core evidence

26. Effects of eslicarbazepine on slow inactivation processes of sodium channels in dentate gyrus granule cells. Full Text available with Trip Pro

Effects of eslicarbazepine on slow inactivation processes of sodium channels in dentate gyrus granule cells. Pharmacoresistance is a problem affecting ∼30% of chronic epilepsy patients. An understanding of the mechanisms of pharmacoresistance requires a precise understanding of how antiepileptic drugs interact with their targets in control and epileptic tissue. Although the effects of (S)-licarbazepine (S-Lic) on sodium channel fast inactivation are well understood and have revealed maintained

2018 Epilepsia

27. Eslicarbazepine acetate (Zebinix®) 800 mg tablets

Eslicarbazepine acetate (Zebinix®) 800 mg tablets Eslicarbazepine acetate (Zebinix®) 800 mg tablets Eslicarbazepine acetate (Zebinix®) 800 mg tablets All Wales Medicines Strategy Group (AWMSG) Record Status This is a bibliographic record of a published health technology assessment. No evaluation of the quality of this assessment has been made for the HTA database. Citation All Wales Medicines Strategy Group (AWMSG). Eslicarbazepine acetate (Zebinix®) 800 mg tablets. Penarth: All Wales (...) Therapeutics and Toxicology Centre (AWTTC), secretariat of the All Wales Medicines Strategy Group (AWMSG). AWMSG Secretariat Assessment Report Advice No. 3512. 2012 Authors' conclusions Eslicarbazepine acetate (Zebinix®) is recommended as an option for restricted use within NHS Wales. Eslicarbazepine acetate (Zebinix®) should be restricted to treatment of highly refractory patients who remain uncontrolled with, or are intolerant to, other anti-epileptic medicine combinations, within its licensed indication

2012 Health Technology Assessment (HTA) Database.

28. Carbamazepine, oxcarbazepine and eslicarbazepine: potential risk of serious skin reactions

Carbamazepine, oxcarbazepine and eslicarbazepine: potential risk of serious skin reactions Carbamazepine, oxcarbazepine and eslicarbazepine: potential risk of serious skin reactions - GOV.UK GOV.UK uses cookies to make the site simpler. or Search Carbamazepine, oxcarbazepine and eslicarbazepine: potential risk of serious skin reactions Risk of serious skin-related adverse drug reactions, including Stevens-Johnson syndrome, occurring with carbamazepine may be increased in the presence of the HLA (...) for the treatment of partial seizures with or without secondary generalisation and is closely structurally related to carbamazepine. Eslicarbazepine (Zebinix) is the active metabolite of oxcarbazepine and indicated as adjunctive therapy in adults with partial onset seizures with or without secondary generalisation. It is well-recognised that severe, potentially life-threatening, skin-related adverse drug reactions, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), can occur rarely

2012 MHRA Drug Safety Update

29. Impact of seizure frequency reduction on health-related quality of life among clinical trial subjects with refractory partial-onset seizures: A pooled analysis of phase III clinical trials of eslicarbazepine acetate. (Abstract)

Impact of seizure frequency reduction on health-related quality of life among clinical trial subjects with refractory partial-onset seizures: A pooled analysis of phase III clinical trials of eslicarbazepine acetate. Subjects who received eslicarbazepine acetate (ESL) as adjunctive therapy experienced significantly greater seizure frequency reduction (SFR) than placebo in three phase III, randomized, double-blind trials. This analysis compared changes in health-related quality of life (HRQOL

2017 Epilepsy & behavior : E&B Controlled trial quality: predicted high

30. Transition from oxcarbazepine to eslicarbazepine acetate: A single center study Full Text available with Trip Pro

Transition from oxcarbazepine to eslicarbazepine acetate: A single center study There is limited clinical evidence for comparison between oxcarbazepine (OXC) and eslicarbazepine acetate (ESL) in terms of tolerability, or how to execute the change from OXC to ESL. We report the process of transitioning patients with focal epilepsy from previous OXC treatment to ESL due to tolerability problems. The rationale for change from OXC is reported, and the outcome with respective to this rationale

2017 Brain and behavior

31. Eslicarbazepine acetate as adjunctive therapy in clinical practice: ESLADOBA study Full Text available with Trip Pro

Eslicarbazepine acetate as adjunctive therapy in clinical practice: ESLADOBA study To 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.Multicenter, 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

2017 Acta neurologica Scandinavica

32. Incidence of seizure exacerbation and seizures reported as adverse events during adjunctive treatment with eslicarbazepine acetate: A pooled analysis of three Phase III controlled trials Full Text available with Trip Pro

Incidence of seizure exacerbation and seizures reported as adverse events during adjunctive treatment with eslicarbazepine acetate: A pooled analysis of three Phase III controlled trials To investigate whether adjunctive eslicarbazepine acetate (ESL) could lead to exacerbation of seizures in some patients.Post-hoc analysis of data pooled from three Phase III trials of adjunctive ESL (studies 301, 302, and 304) for refractory partial-onset seizures (POS). Following an 8-week baseline period

2017 Epilepsia Open Controlled trial quality: uncertain

33. Pooled efficacy and safety of eslicarbazepine acetate as add‐on treatment in patients with focal‐onset seizures: Data from four double‐blind placebo‐controlled pivotal phase III clinical studies Full Text available with Trip Pro

Pooled efficacy and safety of eslicarbazepine acetate as add‐on treatment in patients with focal‐onset seizures: Data from four double‐blind placebo‐controlled pivotal phase III clinical studies Pooled evaluation of the key efficacy and safety profile of eslicarbazepine acetate (ESL) added-on to stable antiepileptic therapy in adults with focal-onset seizures.Data from 1703 patients enrolled in four phase III double-blind, randomized, placebo-controlled studies were pooled and analyzed

2017 CNS neuroscience & therapeutics Controlled trial quality: uncertain

34. Euro-Esli: a European audit of real-world use of eslicarbazepine acetate as a treatment for partial-onset seizures Full Text available with Trip Pro

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

2017 Journal of neurology

35. In Vitro Evaluation of Eslicarbazepine Delivery via Enteral Feeding Tubes Full Text available with Trip Pro

In Vitro Evaluation of Eslicarbazepine Delivery via Enteral Feeding Tubes Purpose: The feasibility of preparing an eslicarbazepine acetate suspension using Aptiom tablets for administration via enteral feeding tubes was evaluated. Methods: Eslicarbazepine acetate suspension (40 mg/mL) was prepared using Aptiom tablets after optimizing the tablet crushing methods and the vehicle composition. A stability-indicating high-performance liquid chromatography (HPLC) method was developed to monitor (...) the eslicarbazepine stability in the prepared suspension. Three enteric feeding tubes of various composition and dimensions were evaluated for the delivery of the suspensions. The suspension was evaluated for the physical and chemical stability for 48 hours. Results: The reproducibility and consistency of particle size reduction was found to be best with standard mortar/pestle. The viscosity analysis and physical stability studies showed that ORA-Plus:water (50:50 v/v) was optimal for suspending ability

2017 Hospital pharmacy

36. Eslicarbazepine Acetate: A New Improvement on a Classic Drug Family for the Treatment of Partial-Onset Seizures Full Text available with Trip Pro

Eslicarbazepine Acetate: A New Improvement on a Classic Drug Family for the Treatment of Partial-Onset Seizures Eslicarbazepine acetate is a new anti-epileptic drug belonging to the dibenzazepine carboxamide family that is currently approved as adjunctive therapy and monotherapy for partial-onset (focal) seizures. The drug enhances slow inactivation of voltage-gated sodium channels and subsequently reduces the activity of rapidly firing neurons. Eslicarbazepine acetate has few, but some, drug (...) -drug interactions. It is a weak enzyme inducer and it inhibits cytochrome P450 2C19, but it affects a smaller assortment of enzymes than carbamazepine. Clinical studies using eslicarbazepine acetate as adjunctive treatment or monotherapy have demonstrated its efficacy in patients with refractory or newly diagnosed focal seizures. The drug is generally well tolerated, and the most common side effects include dizziness, headache, and diplopia. One of the greatest strengths of eslicarbazepine acetate

2017 Drugs in R&D

37. Safety Profile of Eslicarbazepine Acetate as Add-On Therapy in Adults with Refractory Focal-Onset Seizures: From Clinical Studies to 6 Years of Post-Marketing Experience Full Text available with Trip Pro

Safety Profile of Eslicarbazepine Acetate as Add-On Therapy in Adults with Refractory Focal-Onset Seizures: From Clinical Studies to 6 Years of Post-Marketing Experience Eslicarbazepine acetate was first approved in the European Union in 2009 as adjunctive therapy in adults with partial-onset seizures with or without secondary generalization.The objective of this study was to review the safety profile of eslicarbazepine acetate analyzing the data from several clinical studies to 6 years of post (...) -marketing surveillance.We used a post-hoc pooled safety analysis of four phase III, double-blind, randomized, placebo-controlled studies (BIA-2093-301, -302, -303, -304) of eslicarbazepine acetate as add-on therapy in adults. Safety data of eslicarbazepine acetate in special populations of patients aged ≥65 years with partial-onset seizures (BIA-2093-401) and subjects with moderate hepatic impairment (BIA-2093-111) and renal impairment (BIA-2093-112) are also considered. The incidences of treatment

2017 Drug Safety

38. Eslicarbazepine acetate: its effectiveness as adjunctive therapy in clinical trials and open studies Full Text available with Trip Pro

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

2017 Journal of neurology

39. Prediction of efficacy for conversion from adjunctive therapy to monotherapy with eslicarbazepine acetate 800 mg once daily for partial-onset epilepsy Full Text available with Trip Pro

Prediction of efficacy for conversion from adjunctive therapy to monotherapy with eslicarbazepine acetate 800 mg once daily for partial-onset epilepsy Eslicarbazepine acetate (ESL) is a once-daily (QD) oral antiepileptic drug (AED) indicated for partial-onset seizures (POS). Clinical studies of gradual conversion to ESL 1,200 and 1,600 mg QD monotherapies were previously conducted in patients with POS who were not well-controlled by 1 or 2 AEDs. This report describes modeling and simulation (...) of plasma eslicarbazepine (primary active metabolite of ESL) concentrations and time to monotherapy study exit to predict efficacy for conversion to ESL monotherapy at a lower dose of 800 mg, as an option for patients requiring or not tolerating higher doses since this regimen is effective in adjunctive therapy for POS.A previously developed population pharmacokinetic model for ESL monotherapy was used to predict minimum plasma eslicarbazepine concentration (Cmin) in 1,500 virtual patients taking 1 (n

2017 Clinical pharmacology : advances and applications Controlled trial quality: uncertain

40. Development of a stress induced validated UPLC-PDA method for the analysis of Eslicarbazepine acetate Full Text available with Trip Pro

Development of a stress induced validated UPLC-PDA method for the analysis of Eslicarbazepine acetate 30166930 2018 11 14 1319-0164 26 2 2018 Feb Saudi pharmaceutical journal : SPJ : the official publication of the Saudi Pharmaceutical Society Saudi Pharm J Development of a stress induced validated UPLC-PDA method for the analysis of Eslicarbazepine acetate. 286-291 10.1016/j.jsps.2017.11.009 Iram Farah F Department of Pharmaceutical Chemistry, School of Pharmaceutical Education and Research

2017 Saudi Pharmaceutical Journal : SPJ

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