Vigabatrin pediatric dosing information for refractory complex partial seizures: Results from a population dose-response analysis

被引：1

作者：

Nielsen, Jace C. ^{[1
]}

Tolbert, Dwain ^{[2
]}

Patel, Mahlaqa ^{[2
]}

Kowalski, Kenneth G. ^{[1
]}

Wesche, David L. ^{[2
]}

机构：

[1] Ann Arbor Pharmacometr Grp Inc, Ann Arbor, MI 48104 USA

[2] Lundbeck LLC, Deerfield, IL USA

来源：

EPILEPSIA | 2014年 / 55卷 / 12期

关键词：

Vigabatrin; Dosage prediction; Epilepsy; Infantile spasm; Refractory complex partial seizures; LABELING DECISIONS; DRUG APPROVAL; EPILEPSY; CHILDREN; THERAPY; IMPACT; RISK;

D O I：

10.1111/epi.12825

中图分类号：

R74 [神经病学与精神病学];

学科分类号：

摘要：

We predicted vigabatrin dosages for adjunctive therapy for pediatric patients with refractory complex partial seizures (rCPS) that would produce efficacy comparable to that observed for approved adult dosages. A dose-response model related seizure-count data to vigabatrin dosage to identify dosages for pediatric rCPS patients. Seizure-count data were obtained from three pediatric and two adult rCPS clinical trials. Dosages were predicted for oral solution and tablet formulations. Predicted oral solution dosages to achieve efficacy comparable to that of a 1g/day adult dosage were 350 and 450mg/day for patients with body weight ranges 10-15 and >15-20kg, respectively. Predicted oral solution dosages for efficacy comparable to a 3g/day adult dosage were 1,050 and 1,300mg/day for weight ranges 10-15 and >15-20kg, respectively. Predicted tablet dosage for efficacy comparable to a 1g/day adult dosage was 500mg/day for weight ranges 25-60kg. Predicted tablet dosage for efficacy comparable to a 3g/day adult dosage was 2,000mg for weight ranges 25-60kg. Vigabatrin dosages were identified for pediatric rCPS patients with body weights 10kg.

引用

页码：e134 / e138

页数：5

共 31 条

[21] Hypothyroidism (HT) after Radiotherapy (RT) in Children: Initial Results of Thyroid Gland Dose-Response Relationship from the Pediatric Normal Tissue Effects in the Clinic (PENTEC) Initiative
Vogelius, I.
Vargo, J. A.
Ronckers, C. M.
Yorke, E. D.
Kremer, L.
Chafe, S. M. J. M. J.
van Santen, H. M.
Bentzen, S. M.
Constine, L. S.
Milano, M. T.
INTERNATIONAL JOURNAL OF RADIATION ONCOLOGY BIOLOGY PHYSICS, 2019, 105 (01): : S81 - S81
[22] Gabapentin monotherapy .2. A 26-week, double-blind, dose-controlled, multicenter study of conversion from polytherapy in outpatients with refractory complex partial or secondarily generalized seizures
Beydoun, A
Fischer, J
Labar, DR
Harden, C
Cantrell, D
Uthman, BM
Sackellares, JC
AbouKhalil, B
Ramsay, RE
Hayes, A
Greiner, M
Garofalo, E
Pierce, M
NEUROLOGY, 1997, 49 (03) : 746 - 752
[23] Perfluoroalkyl and polyfluoroalkyl substances and cancer risk: results from a dose-response meta-analysis (Mar, 10.1007/s40201-024-00899-w, 2024)
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Zhang, Kui
Shi, Jingyi
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Dai, Hao
Yang, Wenxing
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Vajdi, Mahdi
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Zhou, Simon
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[26] Interim Efficacy and Safety Analysis of Adjunctive Perampanel in the Adolescent Population From the Extension Phase of 3 Double-Blind, Placebo-Controlled, Phase 3 (Core) Studies in Patients with Refractory Partial-Onset Seizures
Renfroe, B.
Yang, H.
Williams, B.
Huang, S.
Laurenza, A.
ANNALS OF NEUROLOGY, 2013, 74 : S172 - S172
[27] The relationship between tooth loss and mortality from all causes, cardiovascular diseases, and coronary heart disease in the general population: systematic review and dose-response meta-analysis of prospective cohort studies
Peng, Juxiang
Song, Jukun
Han, Jing
Chen, Zhu
Yin, Xinhai
Zhu, Jianguo
Song, Jinlin
BIOSCIENCE REPORTS, 2019, 39
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Altman, Jessica K.
Perl, Alexander E.
Cortes, Jorge E.
Levis, Mark J.
Smith, Catherine C.
Litzow, Mark R.
Baer, Maria R.
Claxton, David F.
Erba, Harry P.
Gill, Stanley C.
Goldberg, Stuart L.
Jurcic, Joseph G.
Larson, Richard A.
Lui, Charles
Ritchie, Ellen K.
Sargent, Briana
Schiller, Gary J.
Spira, Alexander I.
Strickland, Stephen A.
Tibes, Raoul
Ustun, Celalettin
Wang, Eunice S.
Stuart, Robert K.
Baldus, Claudia D.
Rollig, Christoph
Neubauer, Andreas
Martinelli, Giovanni
Bahceci, Erkut
BLOOD, 2015, 126 (23)
[29] Dose-response Relation Deduced for Coronaviruses From Coronavirus Disease 2019, Severe Acute Respiratory Syndrome, and Middle East Respiratory Syndrome: Meta-analysis Results and its Application for Infection Risk Assessment of Aerosol Transmission
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CLINICAL INFECTIOUS DISEASES, 2021, 73 (01) : E241 - E245
[30] Inulin-type fructans supplementation improves glycemic control for the prediabetes and type 2 diabetes populations: results from a GRADE-assessed systematic review and dose-response meta-analysis of 33 randomized controlled trials
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Yang, Hong
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