Long-term safety and efficacy of eslicarbazepine acetate as adjunctive therapy in the treatment of partial-onset seizures in adults with epilepsy: Results of a 1-year open-label extension study

Hufnagel, A.; Ben‐Menachem, Elinor; Gabbai, Alberto Alain; Falcão, Amı́lcar; Almeida, Luís; Soares-da-Silva, Patrı́cio

doi:10.1016/j.eplepsyres.2012.07.014

Cited by 75 publications

(62 citation statements)

References 9 publications

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“…Lacosamide was well tolerated during this 8-year OLE trial, with 12.7% of patients discontinuing because of TEAEs, which lies within the range observed for other OLE studies of AEDs between 1 and 8 years of duration [9,10,[16][17][18][19][20][21][22][23]. Overall, the types of SAEs and TEAEs leading to discontinuation during this trial were similar to those observed in the other lacosamide OLE trials, as well as in pivotal double-blind placebo-controlled lacosamide trials [5,7,8], suggesting that long-term treatment with lacosamide was not associated with a different safety profile from that established in the pivotal trials.…”

Section: Discussionmentioning

confidence: 83%

Safety and efficacy of adjunctive lacosamide among patients with partial-onset seizures in a long-term open-label extension trial of up to 8 years

Rosenfeld

Fountain

Kaubrys

et al. 2014

Epilepsy & Behavior

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Section: Discussionmentioning

confidence: 83%

Safety and efficacy of adjunctive lacosamide among patients with partial-onset seizures in a long-term open-label extension trial of up to 8 years

Rosenfeld

Fountain

Kaubrys

et al. 2014

Epilepsy & Behavior

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“…Double‐blind, placebo‐controlled trials of ESL 11, 12 were similar to the PROSPER study in design and study population and were followed by open‐label extension studies. In these extension studies, 69% 13 and 77% 14 of patients completed 1 year of open‐label treatment; discontinuations due to AEs were 4% and 11%, respectively. The seizure‐free rate among patients completing 1 year of open‐label therapy was 2.5% in the one study reporting this endpoint 14.…”

Section: Discussionmentioning

confidence: 99%

“…In these extension studies, 69% 13 and 77% 14 of patients completed 1 year of open‐label treatment; discontinuations due to AEs were 4% and 11%, respectively. The seizure‐free rate among patients completing 1 year of open‐label therapy was 2.5% in the one study reporting this endpoint 14.…”

Section: Discussionmentioning

confidence: 99%

Long‐term efficacy and safety of adjunctive extended‐release oxcarbazepine (Oxtellar XR ^® ) in adults with partial‐onset seizures

et al. 2015

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ObjectiveTo evaluate long‐term outcomes of adjunctive therapy with SPN‐804 (Oxtellar XR®, Supernus Pharmaceuticals), an extended‐release tablet formulation of oxcarbazepine (OXC), in adults with refractory partial‐onset seizures.MethodsAfter completing a 16‐week double‐blind, placebo‐controlled trial of SPN‐804 at fixed dosages (1200 or 2400 mg QD), patients entering this open‐label extension study were converted in blinded fashion to 1200 mg QD SPN‐804 as a target starting dose for long‐term treatment. Patients were followed for 1 year, during which SPN‐804 dosages could be adjusted up to 2400 mg/day according to clinical response.ResultsOf 214 patients, 84% completed 1‐year open‐label treatment. Median maintenance SPN‐804 dosage was 1200 mg; <10% of patients required 2400 mg. Median 28‐day seizure frequency reduction from baseline was 59%; seizure frequency was reduced ≥50% in 58% of patients; 11% were seizure free ≥6 months; and 5% were seizure free ≥1 year. SPN‐804 was discontinued due to adverse events in 5% (n = 10). Incidences of each of the most common adverse events (dizziness, headache, diplopia, nausea, vomiting, balance disorder, blurred vision) were ≤15% during 1‐year follow‐up and occurred most frequently in patients previously naïve to SPN‐804. No new safety signals, no clinically significant changes in health status, and no deaths attributable to SPN‐804 were observed.ConclusionSPN‐804 administered once daily for 1 year was effective as adjunctive therapy in improving seizure control and maintaining therapeutic response in adults with refractory partial‐onset seizures. With dosage flexibility, SPN‐804 was well tolerated.

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“…Furthermore, some side‐effects (diplopia, ataxia, abnormal coordination) were significantly more frequent in OXC‐treated patients compared to ESL and LCM. ESL‐related hyponatremia varies from 1.2% to 8.8% between different studies (Halasz et al., 2010; Hufnagel et al., 2013; Villanueva et al., 2014; Zaccara et al., 2013). The difference can be explained in terms of dosage used, population characteristics, and cut‐off used to define hyponatremia.…”

Section: Introductionmentioning

confidence: 99%

Transition from oxcarbazepine to eslicarbazepine acetate: A single center study

2017

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ObjectivesThere 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 is analyzed in terms of tolerability and efficacy.Materials and MethodsThe subjects were transitioned overnight from OXC to ESL in a hospital inpatient setting. An evaluation of the effects of the transition was made after 1 and 3 months. All adverse events (AEs) were recorded following the transition period. Subjects were classified by outcome in terms of AEs.ResultsTwenty‐three subjects were transitioned from OXC to ESL. Fifteen patients OXC‐related AEs reduced significantly after transition. Particularly, most of (93%) the AEs presented in the morning resolved after transition to ESL. No patient had an increase in seizure frequency following the transition. The incidence of ESL‐related AEs was 39% at 1 month and 13% at 3 month follow‐up; however, all patients continued ESL throughout the study period.ConclusionsThis study demonstrates that patients suffering from OXC‐related AEs improve in terms of tolerability after a switch to ESL with maintaining seizure control. This improvement is more pronounced if the OXC‐related AEs are most evident following morning dosing of OXC. Transition can be safely executed in an outpatient setting.

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Long-term safety and efficacy of eslicarbazepine acetate as adjunctive therapy in the treatment of partial-onset seizures in adults with epilepsy: Results of a 1-year open-label extension study

Cited by 75 publications

References 9 publications

Safety and efficacy of adjunctive lacosamide among patients with partial-onset seizures in a long-term open-label extension trial of up to 8 years

Safety and efficacy of adjunctive lacosamide among patients with partial-onset seizures in a long-term open-label extension trial of up to 8 years

Long‐term efficacy and safety of adjunctive extended‐release oxcarbazepine (Oxtellar XR ^® ) in adults with partial‐onset seizures

Transition from oxcarbazepine to eslicarbazepine acetate: A single center study

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Long-term safety and efficacy of eslicarbazepine acetate as adjunctive therapy in the treatment of partial-onset seizures in adults with epilepsy: Results of a 1-year open-label extension study

Cited by 75 publications

References 9 publications

Safety and efficacy of adjunctive lacosamide among patients with partial-onset seizures in a long-term open-label extension trial of up to 8 years

Safety and efficacy of adjunctive lacosamide among patients with partial-onset seizures in a long-term open-label extension trial of up to 8 years

Long‐term efficacy and safety of adjunctive extended‐release oxcarbazepine (Oxtellar XR ® ) in adults with partial‐onset seizures

Transition from oxcarbazepine to eslicarbazepine acetate: A single center study

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Long‐term efficacy and safety of adjunctive extended‐release oxcarbazepine (Oxtellar XR ^® ) in adults with partial‐onset seizures