Safety and efficacy of rufinamide in children and adults with Lennox-Gastaut syndrome: A post hoc analysis from Study 022
| Autor: | Manoj Malhotra, Alexis Arzimanoglou, Gerhard Kluger, Pierre Genton, Milka Pringsheim, Carlos Perdomo |
|---|---|
| Rok vydání: | 2021 |
| Předmět: |
Pediatrics
medicine.medical_specialty Seizure types business.industry Atypical absence seizures Rufinamide medicine.disease Behavioral Neuroscience Epilepsy Neurology Post-hoc analysis Adjunctive treatment medicine Clinical endpoint Neurology (clinical) business Lennox–Gastaut syndrome medicine.drug |
| Zdroj: | Epilepsybehavior : EB. 124 |
| ISSN: | 1525-5069 |
| Popis: | Lennox-Gastaut syndrome (LGS) is a developmental and epileptic encephalopathy with the first symptoms usually appearing during early childhood. Due to the highly variable underlying etiologies, LGS cannot be considered as one disease but as an electro-clinical entity, often challenging to diagnose early and treat accordingly. The anti-seizure medication, rufinamide, is indicated for the adjunctive treatment of patients with LGS aged ≥1 year. This post hoc analysis assessed the safety and efficacy of adjunctive rufinamide for total and tonic-atonic seizures during Study 022 in children (aged16 years) and adults (aged ≥16 years).Randomized, placebo-controlled, phase III Study 022 included patients with a diagnosis of LGS and a history of multiple seizure types (including tonic-atonic or astatic seizures and atypical absence seizures; ≥90 seizures in the month prior to baseline). Assessments included monitoring of treatment-emergent adverse events (TEAEs), percent change in tonic-atonic seizure frequency/28 days during the double-blind phase relative to study baseline (a primary endpoint), and percentage of patients with ≥25%, ≥50%, or ≥75% reduction in seizure frequency relative to baseline.Of 138 enrolled patients, 74 received rufinamide (16 years, n = 49 [66%]) and 64 received placebo (16 years, n = 43 [67%]). Incidence of TEAEs was generally similar between age groups. The frequency (per 28 days) of tonic-atonic seizures was reduced with rufinamide (vs. placebo) in both younger and older patients: age16 years (-41% vs. -6%), age ≥16 years (-55% vs. +16%) (p 0.025; both age groups). In patients aged16 years receiving rufinamide, 38% and 17% achieved ≥50% and ≥75% reductions in tonic-atonic seizure frequency vs. 18% and 3% with placebo, respectively. Corresponding responder rates for patients aged ≥16 years were 52% and 32% (rufinamide) vs. 15% and 5% (placebo), respectively.In this post hoc analysis, adjunctive rufinamide was well tolerated and improved seizure control in patients with LGS, irrespective of age. |
| Databáze: | OpenAIRE |
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