TY - JOUR
T1 - Sabril® registry 5-year results
T2 - Characteristics of adult patients treated with vigabatrin
AU - Krauss, Gregory
AU - Faught, Edward
AU - Foroozan, Rod
AU - Pellock, John M.
AU - Sergott, Robert C.
AU - Shields, W. Donald
AU - Ziemann, Adam
AU - Dribinsky, Yekaterina
AU - Lee, Deborah
AU - Torri, Sarah
AU - Othman, Feisal
AU - Isojarvi, Jouko
N1 - Funding Information:
Manuscript preparation, including editing and formatting the manuscript, incorporating author comments, preparing tables and figures, and coordinating submission requirements, was provided by Mary Clare Kane, Ph.D. and Apurva Davé, Ph.D. of Prescott Medical Communications Group (Chicago, IL). This editorial support was funded by Lundbeck LLC .
Funding Information:
Dr. Krauss has served as a consultant for Acorda Therapeutics and Sunovion Pharmaceuticals, Inc. He has provided service on Lundbeck LLC's SHARE safety monitoring program for vigabatrin. He is an investigator with funding from SK Life Science, Inc., UCB, Inc., NIH, and Novartis.
Funding Information:
Dr. Pellock has served as a consultant for NIH/NINDS, Acorda Therapeutics, Eisai, Inc., GW Pharmaceuticals, Mallinckrodt Pharmaceuticals, Marinus Pharmaceuticals, Inc., Medscape, NeuroPace, Inc., Lundbeck LLC, Pfizer, Inc., Questcor Pharmaceuticals, Sepracor Pharmaceuticals, Inc., Sunovion Pharmaceuticals, Inc., UCB, Inc., and Upsher-Smith Laboratories, Inc. and has received research funding from NIH/NINDS, Eisai, Inc., GW Pharmaceuticals, Marinus Pharmaceuticals, Inc., Lundbeck LLC, Pfizer, Inc., Questcor Pharmaceuticals, UCB, Inc., and Upsher-Smith Laboratories, Inc.
Publisher Copyright:
© 2015 Elsevier Inc.
PY - 2016/3/1
Y1 - 2016/3/1
N2 - 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.
AB - 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.
KW - Adult patients
KW - Epilepsy
KW - Infantile spasms
KW - Patient registry
KW - Refractory complex partial seizures
KW - Vigabatrin
UR - http://www.scopus.com/inward/record.url?scp=84955120643&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84955120643&partnerID=8YFLogxK
U2 - 10.1016/j.yebeh.2015.12.004
DO - 10.1016/j.yebeh.2015.12.004
M3 - Article
C2 - 26807550
AN - SCOPUS:84955120643
VL - 56
SP - 15
EP - 19
JO - Epilepsy and Behavior
JF - Epilepsy and Behavior
SN - 1525-5050
ER -