title: Registry initiated to characterize vision loss associated with vigabatrin therapy.
abstract: The vigabatrin patient registry was implemented in August 2009 in conjunction with Food and Drug Administration approval of vigabatrin. All US vigabatrin-treated patients must enroll in the registry. Data on prescriber specialty/location, patient demographics, and clinical characteristics are collected. Benefit-risk assessments are required early in the course of therapy. Vision assessments are required at baseline (≤4 weeks after therapy initiation), every 3 months during therapy, and 3 to 6 months after discontinuation. As of February 1, 2011, 2473 patients (1500 with infantile spasms, 846 with refractory complex partial seizures, 120 with other diagnoses) had enrolled; 30.4% were previously exposed to vigabatrin. Kaplan-Meier analysis of time in registry indicated that 83 and 97% of all enrolled patients with refractory complex partial seizures and infantile spasms remained beyond 3 and 1 month, respectively. The ongoing registry will provide visual status and other information on vigabatrin-treated patients for both the infantile spasm and refractory complex partial seizure indications.
authors: Virginia Commonwealth University, Richmond, VA, USA.
authors: John M
authors: JM
authors: Pellock
authors: Edward
authors: E
authors: Faught
authors: Robert C
authors: RC
authors: Sergott
authors: W Donald
authors: WD
authors: Shields
authors: Gregory A
authors: GA
authors: Burkhart
authors: Gregory L
authors: GL
authors: Krauss
authors: Rod
authors: R
authors: Foroozan
authors: David L
authors: DL
authors: Wesche
authors: Mark A
authors: MA
authors: Weinberg
mesh_terms: D000293:Adolescent; D000328:Adult; D000927:Anticonvulsants / Q000009:adverse effects*; D002648:Child; D002675:Child, Preschool; D004827:Epilepsy / Q000188:drug therapy; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D016013:Likelihood Functions; D008297:Male; D012042:Registries; D012189:Retrospective Studies; D041623:Tomography, Optical Coherence; D020888:Vigabatrin / Q000009:adverse effects*; D014786:Vision Disorders / Q000139:chemically induced* / Q000175:diagnosis; D058609:Visual Field Tests; D055815:Young Adult
chemical_list: D000927:Anticonvulsants; D020888:Vigabatrin