Clinical profile of vigabatrin as monotherapy for treatment of infantile spasms
Jason T Lerner1, Noriko Salamon2, Raman Sankar1,31Departments of Pediatrics, 2Radiological Sciences, 3Neurology, David Geffen School of Medicine, University of California Los Angeles and Mattel Children’s Hospital at UCLA, Los Angeles, CA, USAAbstract: Vigabatrin, the first therapeutic...
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Dove Medical Press
2010
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oai:doaj.org-article:3d72d9adf5de4e4cb3c10c2c6ecb8ce32021-12-02T08:53:51ZClinical profile of vigabatrin as monotherapy for treatment of infantile spasms1176-63281178-2021https://doaj.org/article/3d72d9adf5de4e4cb3c10c2c6ecb8ce32010-11-01T00:00:00Zhttp://www.dovepress.com/clinical-profile-of-vigabatrin-as-monotherapy-for-treatment-of-infanti-a5599https://doaj.org/toc/1176-6328https://doaj.org/toc/1178-2021Jason T Lerner1, Noriko Salamon2, Raman Sankar1,31Departments of Pediatrics, 2Radiological Sciences, 3Neurology, David Geffen School of Medicine, University of California Los Angeles and Mattel Children’s Hospital at UCLA, Los Angeles, CA, USAAbstract: Vigabatrin, the first therapeutic agent to be approved by the Food and Drug Administration for the treatment of infantile spasms, as well as for adjunctive use in the treatment of refractory complex partial epilepsy, represents an important advance for patients with difficult-to-manage epilepsy. This review summarizes the complex history, chemistry, and pharmacology, as well as the clinical data leading to the approval of vigabatrin for infantile spasms in the US. The long path to its approval reflects the visual system and white matter toxicity concerns with this agent. This review provides a brief description of these concerns, and the regulatory safety monitoring and mitigation systems that have been put in place to enhance benefit over risk.Keywords: vigabatrin, infantile spasms, monotherapy Jason T LernerNoriko SalamonRaman SankarDove Medical PressarticleNeurosciences. Biological psychiatry. NeuropsychiatryRC321-571Neurology. Diseases of the nervous systemRC346-429ENNeuropsychiatric Disease and Treatment, Vol 2010, Iss Issue 1, Pp 731-740 (2010) |
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Neurosciences. Biological psychiatry. Neuropsychiatry RC321-571 Neurology. Diseases of the nervous system RC346-429 |
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Neurosciences. Biological psychiatry. Neuropsychiatry RC321-571 Neurology. Diseases of the nervous system RC346-429 Jason T Lerner Noriko Salamon Raman Sankar Clinical profile of vigabatrin as monotherapy for treatment of infantile spasms |
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Jason T Lerner1, Noriko Salamon2, Raman Sankar1,31Departments of Pediatrics, 2Radiological Sciences, 3Neurology, David Geffen School of Medicine, University of California Los Angeles and Mattel Children’s Hospital at UCLA, Los Angeles, CA, USAAbstract: Vigabatrin, the first therapeutic agent to be approved by the Food and Drug Administration for the treatment of infantile spasms, as well as for adjunctive use in the treatment of refractory complex partial epilepsy, represents an important advance for patients with difficult-to-manage epilepsy. This review summarizes the complex history, chemistry, and pharmacology, as well as the clinical data leading to the approval of vigabatrin for infantile spasms in the US. The long path to its approval reflects the visual system and white matter toxicity concerns with this agent. This review provides a brief description of these concerns, and the regulatory safety monitoring and mitigation systems that have been put in place to enhance benefit over risk.Keywords: vigabatrin, infantile spasms, monotherapy |
format |
article |
author |
Jason T Lerner Noriko Salamon Raman Sankar |
author_facet |
Jason T Lerner Noriko Salamon Raman Sankar |
author_sort |
Jason T Lerner |
title |
Clinical profile of vigabatrin as monotherapy for treatment of infantile spasms |
title_short |
Clinical profile of vigabatrin as monotherapy for treatment of infantile spasms |
title_full |
Clinical profile of vigabatrin as monotherapy for treatment of infantile spasms |
title_fullStr |
Clinical profile of vigabatrin as monotherapy for treatment of infantile spasms |
title_full_unstemmed |
Clinical profile of vigabatrin as monotherapy for treatment of infantile spasms |
title_sort |
clinical profile of vigabatrin as monotherapy for treatment of infantile spasms |
publisher |
Dove Medical Press |
publishDate |
2010 |
url |
https://doaj.org/article/3d72d9adf5de4e4cb3c10c2c6ecb8ce3 |
work_keys_str_mv |
AT jasontlerner clinicalprofileofvigabatrinasmonotherapyfortreatmentofinfantilespasms AT norikosalamon clinicalprofileofvigabatrinasmonotherapyfortreatmentofinfantilespasms AT ramansankar clinicalprofileofvigabatrinasmonotherapyfortreatmentofinfantilespasms |
_version_ |
1718398296262705152 |