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

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Title: Safety and retention rate of rufinamide in 300 patients: A single pediatric epilepsy center experience.
Authors: Thome‐Souza, 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
Source: Epilepsia (Series 4). Aug2014, Vol. 55 Issue 8, p1235-1244. 10p.
Subjects: Safety standards, Drug efficacy, Genetics of epilepsy, Medical emergencies, Patient satisfaction
Abstract: 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 . [ABSTRACT FROM AUTHOR]
Copyright of Epilepsia (Series 4) is the property of Wiley-Blackwell and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
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  Data: Safety and retention rate of rufinamide in 300 patients: A single pediatric epilepsy center experience.
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  Data: <searchLink fieldCode="AR" term="%22Thome‐Souza%2C+Sigride%22">Thome‐Souza, Sigride</searchLink><br /><searchLink fieldCode="AR" term="%22Kadish%2C+Navah+E%2E%22">Kadish, Navah E.</searchLink><br /><searchLink fieldCode="AR" term="%22Ramgopal%2C+Sriram%22">Ramgopal, Sriram</searchLink><br /><searchLink fieldCode="AR" term="%22Sánchez+Fernández%2C+Iván%22">Sánchez Fernández, Iván</searchLink><br /><searchLink fieldCode="AR" term="%22Bergin%2C+Ann+M%2E%22">Bergin, Ann M.</searchLink><br /><searchLink fieldCode="AR" term="%22Bolton%2C+Jeffrey%22">Bolton, Jeffrey</searchLink><br /><searchLink fieldCode="AR" term="%22Harini%2C+Chellamani%22">Harini, Chellamani</searchLink><br /><searchLink fieldCode="AR" term="%22Libenson%2C+Mark%22">Libenson, Mark</searchLink><br /><searchLink fieldCode="AR" term="%22Olson%2C+Heather%22">Olson, Heather</searchLink><br /><searchLink fieldCode="AR" term="%22Peters%2C+Jurriaan%22">Peters, Jurriaan</searchLink><br /><searchLink fieldCode="AR" term="%22Poduri%2C+Annapurna%22">Poduri, Annapurna</searchLink><br /><searchLink fieldCode="AR" term="%22Rotenberg%2C+Alexander%22">Rotenberg, Alexander</searchLink><br /><searchLink fieldCode="AR" term="%22Takeoka%2C+Masanori%22">Takeoka, Masanori</searchLink><br /><searchLink fieldCode="AR" term="%22Kothare%2C+Sanjeev+V%2E%22">Kothare, Sanjeev V.</searchLink><br /><searchLink fieldCode="AR" term="%22Kapur%2C+Kush%22">Kapur, Kush</searchLink><br /><searchLink fieldCode="AR" term="%22Bourgeois%2C+Blaise+F%2E+D%2E%22">Bourgeois, Blaise F. D.</searchLink><br /><searchLink fieldCode="AR" term="%22Loddenkemper%2C+Tobias%22">Loddenkemper, Tobias</searchLink>
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  Data: <searchLink fieldCode="JN" term="%22Epilepsia+%28Series+4%29%22">Epilepsia (Series 4)</searchLink>. Aug2014, Vol. 55 Issue 8, p1235-1244. 10p.
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  Data: <searchLink fieldCode="DE" term="%22Safety+standards%22">Safety standards</searchLink><br /><searchLink fieldCode="DE" term="%22Drug+efficacy%22">Drug efficacy</searchLink><br /><searchLink fieldCode="DE" term="%22Genetics+of+epilepsy%22">Genetics of epilepsy</searchLink><br /><searchLink fieldCode="DE" term="%22Medical+emergencies%22">Medical emergencies</searchLink><br /><searchLink fieldCode="DE" term="%22Patient+satisfaction%22">Patient satisfaction</searchLink>
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  Data: 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 . [ABSTRACT FROM AUTHOR]
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  Data: <i>Copyright of Epilepsia (Series 4) is the property of Wiley-Blackwell and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract.</i> (Copyright applies to all Abstracts.)
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        Value: 10.1111/epi.12689
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