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dc.contributor.author | Rogin, Joanne | |
dc.contributor.author | Resnick, Trevor | |
dc.contributor.author | Strom, Laura | |
dc.contributor.author | Ben-Menachem, Elinor | |
dc.contributor.author | Kochen, Silvia | |
dc.contributor.author | Blum, David | |
dc.contributor.author | Gama, Helena | |
dc.contributor.author | Soares-da-Silva, Patrício | |
dc.contributor.author | Li, Yan | |
dc.contributor.author | Grinnell, Todd | |
dc.date.accessioned | 2023-03-28T18:43:41Z | |
dc.date.available | 2023-03-28T18:43:41Z | |
dc.date.issued | 2019-12-30 | |
dc.identifier.citation | Rogin J, Resnick T, Strom L, et al. Analysis of cutaneous allergic reactions in clinical trials of eslicarbazepine acetate. Acta Neurol Scand. 2020;00:1–8. https://doi.org/10.1111/ane.13218 | es_AR |
dc.identifier.other | https://doi.org/10.1111/ane.13218 | |
dc.identifier.uri | http://repositorio.hospitalelcruce.org/xmlui/handle/123456789/1349 | |
dc.description | Fil: Rogin, Joanne Midwest Center for Seizure Disorders, Minneapolis Clinic of Neurology, Golden Valley. MN; USA | es |
dc.description | Fil: Resnick, Trevor Department of Neurology, Nicklaus Children’s Hospital, Florida International University. Miami, FL; USA | es |
dc.description | Fil: Strom Laura Department of Neurology, University of Colorado Denver Health Sciences. Aurora, CO; USA | es |
dc.description | Fil: Ben-Menachem, Elinor Sahlgrenska Academy Institute of Neuroscience and Physiology. Goteborg; Sweden | es |
dc.description | Fil: Kochen, Silvia Neurosciences and Complex Systems Unit (ENyS), Epilepsy Section, CONICET, Hospital El Cruce “N. Kirchner”, University National A. Jauretche (UNAJ), University Buenos Aires. Buenos Aires; Argentina | es |
dc.description | Fil: Blum, David Sunovion Pharmaceuticals Inc., Marlborough. MA; USA | es |
dc.description | Fil: Gama, Helena BIAL - Portela & Ca, S.A., S. Mamede do Coronado; Portugal | es |
dc.description | Fil: Soares-da-Silva, Patrício BIAL - Portela & Ca, S.A., S. Mamede do Coronado; Portugal | es |
dc.description | Fil: Li, Yan Sunovion Pharmaceuticals Inc., Marlborough. MA; USA | es |
dc.description | Fil: Grinnell, Todd Sunovion Pharmaceuticals Inc., Marlborough. MA; USA | es |
dc.description.abstract | Objectives To evaluate cutaneous allergic reactions in clinical trials of adjunctive eslicarbazepine acetate (ESL) for focal seizures. Materials and methods Data were analyzed from three phase III randomized, double-blind, placebo-controlled studies of adjunctive ESL in adults (placebo, n = 426; ESL, n = 1021) and two randomized, double-blind, placebo-controlled studies (and open-label extensions [OLEs]) of adjunctive ESL in children aged 4-17 years (placebo, n = 160; ESL, n = 202; OLE, n = 337). Results Adult studies: Rash (ESL 1.9%, placebo 0.9%) and pruritus (ESL 1.2%, placebo 0.9%) were the most frequent rash-related treatment-emergent adverse events (TEAEs). Most rash-related TEAEs were mild or moderate in severity. Incidence of rash increased with increasing ESL dose, but was not higher for patients who initiated treatment with higher ESL doses. Pediatric studies: Allergic dermatitis (ESL 3.0%, placebo 0) and rash (controlled studies: ESL 1.0%, placebo 1.3%; OLE periods: ESL ≤1.2%) were the most frequent rash-related TEAEs. There was one case of DRESS in the ESL group. Most rash-related TEAEs were mild or moderate in severity and judged as not related to treatment with ESL. Conclusions Serious skin rashes were rare during adult and pediatric clinical trials of ESL. Although the incidence of rash with ESL was low, it is important for patients/caregivers to be made aware of the potential signs and symptoms associated with serious skin rashes. | es_AR |
dc.language.iso | en | es_AR |
dc.relation.ispartofseries | Acta Neurol Scand. 2020;00:1–8 | |
dc.subject | Allergic Reaction | es_AR |
dc.subject | Epilepsy Syndrome | es_AR |
dc.subject | Focal Seizure | es_AR |
dc.title | Analysis of cutaneous allergic reactions in clinical trials of eslicarbazepine acetate | es_AR |
dc.type | Article | es_AR |