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Safety and retention rate of rufinamide in 300 patients: A single pediatric epilepsy center experience
Author(s) -
ThomeSouza Sigride,
Kadish Navah E.,
Ramgopal Sriram,
Sánchez Fernández Iván,
Bergin Ann M.,
Bolton Jeffrey,
Harini Chellamani,
Libenson Mark,
Olson Heather,
Peters Jurriaan,
Poduri Annapurna,
Rotenberg Alexander,
Takeoka Masanori,
Kothare Sanjeev V.,
Kapur Kush,
Bourgeois Blaise F. D.,
Loddenkemper Tobias
Publication year - 2014
Publication title -
epilepsia
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.687
H-Index - 191
eISSN - 1528-1167
pISSN - 0013-9580
DOI - 10.1111/epi.12689
Subject(s) - medicine , epilepsy , pediatrics , nausea , vomiting , single center , adverse effect , seizure types , etiology , prospective cohort study , refractory (planetary science) , anesthesia , surgery , psychiatry , physics , astrobiology
Summary Objective 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. A PowerPoint slide summarizing this article is available for download in the Supporting Information section here .