title: Sabril® registry 5-year results: Characteristics of adult patients treated with vigabatrin.
abstract: Vigabatrin (Sabril®), approved in the US in 2009, is currently indicated as adjunctive therapy for refractory complex partial seizures (rCPS) in patients ≥ 10 years old who have responded inadequately to several alternative treatments and as monotherapy for infantile spasms (IS) in patients 1 month to 2 years of age. Because of reports of vision loss following vigabatrin exposure, FDA approval required a risk evaluation mitigation strategy (REMS) program. Vigabatrin is only available in the US through Support, Help, And Resources for Epilepsy (SHARE), which includes a mandated registry. This article describes 5 years of demographic and treatment exposure data from adult patients (≥ 17 years old) in the US treated with vigabatrin and monitored in the ongoing Sabril® registry. Registry participation is mandatory for all US Sabril® prescribers and patients. A benefit-risk assessment must be documented by the physician for a patient to progress to maintenance therapy, defined as 1 month of vigabatrin treatment for patients with IS and 3 months for patients with rCPS. Ophthalmologic assessments must be documented during and after completion of therapy. As of August 26, 2014, a total of 6823 patients were enrolled in the registry, of which 1200 were adults at enrollment. Of these patients, 1031 (86%) were naïve to vigabatrin. The majority of adult patients (n=783, 65%) had previously been prescribed ≥ 4 AEDs, and 719 (60%) were receiving ≥ 3 concomitant AEDs at vigabatrin initiation. Prescribers submitted an initial ophthalmological assessment form for 863 patients; an ophthalmologic exam was not completed for 300 (35%) patients and thus, were considered exempted from vision testing. Of these patients, 128 (43%) were exempted for neurologic disabilities. Clinicians discontinued treatment in 8 patients because of visual field deficits (VFD) (5 patients naïve to vigabatrin and 3 patients previously exposed). Based on Kaplan-Meier survival estimates, it is estimated that approximately 71%, 55%, and 40% of adult patients naïve to vigabatrin would remain in the registry at 3, 6, and 12 months, respectively. These demographic data suggest that a proportion of adult patients remain on vigabatrin long-term despite the risks of adverse events and significant underlying AED resistance and neurologic disease.
authors.affiliation: Johns Hopkins University, Baltimore, MD, USA. Electronic address: gkrauss@jhmi.edu.
authors.forename: Gregory
authors.initials: G
authors.lastname: Krauss
authors.affiliation: Emory University Hospital, Atlanta, GA, USA.
authors.forename: Edward
authors.initials: E
authors.lastname: Faught
authors.affiliation: Baylor College of Medicine, Houston, TX USA.
authors.forename: Rod
authors.initials: R
authors.lastname: Foroozan
authors.affiliation: Virginia Commonwealth University, Richmond, VA, USA.
authors.forename: John M
authors.initials: JM
authors.lastname: Pellock
authors.affiliation: Wills Eye Institute and Thomas Jefferson University Medical College, Philadelphia, PA, USA.
authors.forename: Robert C
authors.initials: RC
authors.lastname: Sergott
authors.affiliation: UCLA Medical Center, Los Angeles, CA, USA.
authors.forename: W Donald
authors.initials: WD
authors.lastname: Shields
authors.affiliation: Lundbeck, Deerfield, IL, USA.
authors.forename: Adam
authors.initials: A
authors.lastname: Ziemann
authors.affiliation: Lundbeck, Deerfield, IL, USA.
authors.forename: Yekaterina
authors.initials: Y
authors.lastname: Dribinsky
authors.affiliation: Lundbeck, Deerfield, IL, USA.
authors.forename: Deborah
authors.initials: D
authors.lastname: Lee
authors.affiliation: Lundbeck, Deerfield, IL, USA.
authors.forename: Sarah
authors.initials: S
authors.lastname: Torri
authors.affiliation: Lundbeck, Deerfield, IL, USA.
authors.forename: Feisal
authors.initials: F
authors.lastname: Othman
authors.affiliation: Lundbeck, Deerfield, IL, USA.
authors.forename: Jouko
authors.initials: J
authors.lastname: Isojarvi
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000927:Anticonvulsants / Q000009:adverse effects* / Q000627:therapeutic use*; D004827:Epilepsy / Q000188:drug therapy*; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D012042:Registries; D018570:Risk Assessment; D016019:Survival Analysis; D016896:Treatment Outcome; D020888:Vigabatrin / Q000009:adverse effects* / Q000627:therapeutic use*; D014786:Vision Disorders / Q000139:chemically induced / Q000453:epidemiology; D014787:Vision Tests; D058609:Visual Field Tests; D055815:Young Adult
chemical_list: D000927:Anticonvulsants; D020888:Vigabatrin
keywords: Adult patients; Epilepsy; Infantile spasms; Patient registry; Refractory complex partial seizures; Vigabatrin