Rufinamide as an adjuvant treatment in children with Lennox-Gastaut syndrome

Kim, Shin Hye; Eun, So Hee; Kang, Hoon Chul; Kwon, Eun Ji; Byeon, Jung Hye; Lee, Young Mock; Lee, Joon Soo; Eun, Baik Lin; Kim, Heung Dong

doi:10.1016/j.seizure.2012.02.006

Cited by 36 publications

(40 citation statements)

References 14 publications

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“…Limitations common to several previously published post-marketing observational studies of RFM in refractory epilepsy include short follow up times, variable or unspecified time points for efficacy assessment, small sample sizes, populations restricted to one epilepsy type, and the retrospective use of the 50% responder rate outcome measure (Dahlin and Ohman, 2012; Joseph et al, 2011; Kim et al, 2013, 2012; Kluger et al, 2009; Mueller et al, 2011; Olson et al, 2011; Thome-Souza et al, 2014; Vendrame et al, 2010). Particularly in studies reporting efficacy at short assessment times, “honeymoon periods” may not be distinguishable from sustained efficacy, which limits the impact of those studies on clinical decision making.…”

Section: Discussionmentioning

confidence: 99%

“…Since then, a number of studies have investigated the efficacy of RFM in children with other epilepsy types as well, including epileptic spasms and refractory epilepsy more generally (Coppola et al, 2014, 2013, 2011, 2010; Grosso et al, 2014; Joseph et al, 2011; Kim et al, 2013, 2012; Kluger et al, 2010a; Mueller et al, 2011a,b; Olson et al, 2011; Thome-Souza et al, 2014). In addition, RFM now has an indication for adjunctive therapy in refractory partial seizures in adults and adolescents (Brodie et al, 2009).…”

Section: Introductionmentioning

confidence: 99%

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Retention rates of rufinamide in pediatric epilepsy patients with and without Lennox–Gastaut Syndrome

et al. 2015

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Summary Objective To evaluate the effectiveness of rufinamide (RFM) in patients with Lennox–Gastaut Syndrome (LGS) compared to those with other epilepsy syndromes using time to treatment failure (retention rate) as the outcome measure. Methods In this retrospective cohort study, characteristics and outcomes of all patients receiving RFM in 2009 and 2010 were recorded. The primary outcome measure was RFM failure, defined as discontinuation of RFM or initiation of an additional antiepileptic therapy. The secondary outcome measure was discontinuation of RFM. Kaplan–Meier method survival curves were generated for time to RFM failure, for all patients and by the presence or absence of Lennox Gastaut Syndrome (LGS). The impact of age, seizure type, fast or slow drug titration, and concomitant therapy with valproate on retention rate were evaluated using Cox regression models. Results One hundred thirty-three patients were included, 39 (30%) of whom had LGS. For all patients, the probability of remaining on RFM without additional therapy was 45% at 12 months and 30% at 24 months. LGS diagnosis was an independent predictor of time to RFM failure (HR 0.51, 95% CI 0.31–0.83), with a median time to failure of 18 months in LGS compared to 6 months in all others (p = 0.006). Conclusions In a broad population of children with refractory epilepsy, around half will continue taking the medication for at least a year without additional therapy. Patients with LGS are two times more likely to continue RFM without additional therapy compared to those without LGS.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Retention rates of rufinamide in pediatric epilepsy patients with and without Lennox–Gastaut Syndrome

et al. 2015

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“…Despite growing evidence that supports the efficacy of rufinamide in the broader pediatric epilepsy setting, there are only few prospective randomized studies that include a high number of patients and long‐term follow‐up . The majority of studies report short follow‐up periods, mostly ranging from 28 days to 14.5 months, with an average follow‐up duration of 6 months …”

Section: Clinical Studies Conducted With Rufinamide In the Pediatric mentioning

confidence: 99%

Safety and retention rate of rufinamide in 300 patients: A single pediatric epilepsy center experience

et al. 2014

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Sigride ThomeSouza is a clinical neurophysiologist, epileptologist, and pediatric neurologist. SUMMARYObjective: Reports of studies evaluating rufinamide as an add-on therapy in children and adolescents with refractory epilepsy are restricted to a few publications. Prospective multicenter studies including children and adults have yielded important information about several types of epilepsies and syndromes. We evaluated the use of rufinamide in a single pediatric center with a large cohort and long-term follow-up period. Methods: We retrospectively included patients taking rufinamide from November 2008 to March 2013. Response was defined by a seizure reduction of ≥50% compared to baseline. Results: Three hundred patients with a median age of 9.1 years (range 0.4-29.6 years) were reviewed. Median follow-up was 9 months (range 1-37 months). Epilepsy etiology was classified as genetic (23.7%), structural/metabolic (41%), and unknown cause (35.3%). Overall, rufinamide treatment led to a median seizure frequency reduction of 59.2% from responders to baseline. Seizure reduction was greater in patients with genetic etiology compared to structural/metabolic (66.2% vs. 45.5% responders, p = 0.005). Rufinamide was discontinued in 110 (36.7%) of 300 patients: 63 (21%) due to unsatisfactory response, 47 (15.7%) due to side effects, and in 18 (6%) of those due to both. Most common adverse effects were sleepiness, vomiting, mood changes, nausea, and loss of appetite. Median time to loss of efficacy was 11.6 months (range 3-28 months). Significance: Rufinamide provides satisfactory seizure reduction as an adjunctive treatment in refractory epilepsy. Results need to be interpreted in the setting of data acquisition, including inherent biases of retrospective studies. Patients with a known genetic etiology may have better responses than patients with structural/metabolic etiology.

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“…The pooled tolerability and safety analysis involved 1978 patients examined for long-term tolerability and safety (mean age 31.3 years, mean RUF dose 1700 mg/ day, maximum dose 7200 mg/day), 47% of whom were treated with RUF for at least 12 months; the most commonly reported adverse events in this population were headache (29.5%), dizziness (22.5%), and fatigue (17.7%). [7][8][9][10][11][12][13][14][15] In other study 139 recipients who done a multicenter, double-blind, placebo-controlled, randomized study of RUF as add-on therapy for seizures associated with LGS, 124 continued into an open-label extension phase with a median treatment period of 432 days. Only 12 of these recipients finally stopped the medication due to adverse side-effects such as vomiting, pyrexia, upper respiratory tract infection, and somnolence.…”

Section: Tolerability and Safety Of Rufmentioning

confidence: 99%

Rufinamide: treatment of seizures associated with Lennox-Gastaut syndrome

Allu¹,

Muduveti²,

Vineela³

et al. 2014

Int J Basic Clin Pharmacol

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Rufinamide as an adjuvant treatment in children with Lennox-Gastaut syndrome

Abstract: Rufinamide appears to be a safe and effective adjuvant treatment for many cases of intractable LGS.

Cited by 36 publications

References 14 publications

Retention rates of rufinamide in pediatric epilepsy patients with and without Lennox–Gastaut Syndrome

Retention rates of rufinamide in pediatric epilepsy patients with and without Lennox–Gastaut Syndrome

Safety and retention rate of rufinamide in 300 patients: A single pediatric epilepsy center experience

Rufinamide: treatment of seizures associated with Lennox-Gastaut syndrome

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