Pharmacokinetic-pharmacodynamic assessment of topiramate dosing regimens for children with epilepsy 2 to <10 years of age

Epilepsia

Volumn 51, Issue 10, 2010, Pages 1954-1962

  Girgis, Ihab G ^a   Nandy, Partha ^a   Nye, Jeffrey S ^b   Ford, Lisa ^b   Mohanty, Surya ^a   Wang, Steven ^c   Ochalski, Stefan ^d   Eerdekens, Marielle ^b   Cox, Eugène ^a  

^a Clinical Pharmacology   (United States)

^b Neuroscience Division   (United States)

^c Clinical Biostatistics   (United States)

^d JOHNSON AND JOHNSON PHARMACEUTICAL RESEARCH AND DEVELOPMENT   (United States)

Author keywords

Bridging; Dosing; Pediatric; Pharmacokinetic pharmacodynamic modeling; Topiramate

Indexed keywords

PLACEBO; TOPIRAMATE;

ADOLESCENT; ADULT; AGED; ARTICLE; BODY WEIGHT; CHILD; CONTROLLED STUDY; DRUG BLOOD LEVEL; DRUG DISPOSITION; DRUG DISTRIBUTION; EPILEPSY; HUMAN; INFANT; MAJOR CLINICAL STUDY; MONOTHERAPY; MORBIDITY; PRESCHOOL CHILD; PRIORITY JOURNAL; SCHOOL CHILD; STEADY STATE;

ADOLESCENT; ADULT; AGE DISTRIBUTION; AGE FACTORS; AGED; AGED, 80 AND OVER; ANTICONVULSANTS; BODY WEIGHT; CHILD; CHILD, PRESCHOOL; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG ADMINISTRATION SCHEDULE; DRUG THERAPY, COMBINATION; EPILEPSY; FEMALE; FRUCTOSE; HUMANS; MALE; METABOLIC CLEARANCE RATE; MIDDLE AGED; MODELS, BIOLOGICAL; RANDOMIZED CONTROLLED TRIALS AS TOPIC; TREATMENT OUTCOME;

EID: 78649308215     PISSN: 00139580     EISSN: 15281167     Source Type: Journal    
DOI: 10.1111/j.1528-1167.2010.02598.x     Document Type: Article

References (24)

1. Arroyo S, Dodson WE, Privitera MD, Glauser TA, Naritoku DK, Dlugos DJ, Wang S, Schwabe SK, Twyman RE,; EPMN-106/INT-28 Investigators. (2005) Randomized dose-controlled study of topiramate as first-line therapy in epilepsy. Acta Neurol Scand 112: 214-222.
2. Battino D, Croci D, Rossini A, Messina S, Mamoli D, Perucca E,. (2005) Topiramate pharmacokinetics in children and adults with epilepsy: a case-matched comparison based on therapeutic drug monitoring data. Clin Pharmacokinet 44: 407-416. (Pubitemid 40663685)
3. Beardsley RS, Freeman M, Appel I-A,. (1983) Anticonvulsant serum levels are useful only if the physician appropriately uses them: an assessment of the impact of providing serum level data to physicians. Epilepsia 24: 330-335.
4. Della Paschoa OE, Mandema JW, Voskuyl RA, Danhof M,. (1998) Pharmacokinetic-pharmacodynamic modeling of the anticonvulsant and electroencephalogram effects of phenytoin in rats. J Pharmacol Exp Ther 284: 460-466.
5. Doose DR, Walker SA, Gisclon LG, Nayak RK,. (1996) Single-dose pharmacokinetics and effect of food on the bioavailability of topiramate, a novel antiepileptic drug. J Clin Pharmacol 36: 884-891.
6. Gilliam FG, Veloso F, Bomhof MA, Gazda SK, Biton V, Ter Bruggen JP, Neto W, Bailey C, Pledger G, Wu SC,. (2003) A dose-comparison trial of topiramate as monotherapy in recently diagnosed partial epilepsy. Neurology 60: 196-202.
7. Girgis IG, Nandy P, Nye JS, Ford L, Wang S, Cox E, (2009) Pharmacokinetic-pharmacodynamic assessment of topiramate adjunctive therapy in epilepsy. American Conference on Pharmacometrics, Mashantucket, CT, U.S.A.
8. Glauser TA, Dlugos DJ, Dodson WE, Grinspan A, Wang S, Wu SC,; EPMN-106/INT-28 Investigators. (2007) Topiramate monotherapy in newly diagnosed epilepsy in children and adolescents. J Child Neurol 22: 693-699.
9. Grosso S, Franzoni E, Iannetti P, Incorpora G, Cardinali C, Toldo I, Verrotti A, Caterina Moscato F, Lo Faro V, Mazzone L, Zamponi N, Boniver C, Spalice A, Parisi P, Morgese G, Balestri P,. (2005a) Efficacy and safety of topiramate in refractory epilepsy of childhood: long-term follow-up study. J Child Neurol 20: 893-897.
10. Grosso S, Galimberti D, Farnetani MA, Cioni M, Mostardini R, Vivarelli R, Di Bartolo RM, Bernardoni E, Berardi R, Morgese G, Balestri P,. (2005b) Efficacy and safety of topiramate in infants according to epilepsy syndromes. Seizure 14: 183-189.
11. Jacqmin P, Labouret N, Gueyffier F,. (2005) Modeling and clinical trials in paediatrics. Therapie 60: 379-390.
12. Krakow K, Lengler U, Rettig K, Schreiner A, Schauble B,. (2007) Topiramate in add-on therapy: results from an open-label, observational study. Seizure 16: 593-600.
13. Lyseng-Williamson KA, Yang LP,. (2008) Spotlight on topiramate in epilepsy. CNS Drugs 22: 171-174.
14. Malphrus AD, Wilfong AA,. (2007) Use of the newer antiepileptic drugs in pediatric epilepsies. Curr Treat Options Neurol 9: 256-267.
15. Mandema JW, Verotta D, Sheiner LB,. (1992) Building population pharmacokinetic pharmacodynamic models. I. Models for covariate effects. J Pharmacokinet Pharmacodyn 20: 511-528.
16. Meibohm B, Läer S, Panetta JC, Barrett JS,. (2005) Population pharmacokinetic studies in pediatrics: issues in design and analysis. AAPS J 7: E475-E487.
17. Miura H,. (2004) Zonisamide monotherapy with once-daily dosing in children with cryptogenic localization-related epilepsies: clinical effects and pharmacokinetic studies. Seizure 13 (suppl 1): S17-S23.
18. Nandy P, Girgis IG, Cox E, Mould DR, Ness S, Ford L, (2010) Population pharmacokinetic modeling and simulation to support pediatric treatment of seizure with topiramate. To be submitted to Clinical Pharmacokinetics.
19. Nedelman JR, Rubin DB, Sheiner LB,. (2007) Diagnostics for confounding in PK/PD models for oxcarbazepine. Stat Med 26: 290-308.
20. Ramsay RE, Uthman B, Pryor FM, Rowan AJ, Bainbridge J, Spitz M, Sirven JI, Frederick TE,. (2008) Topiramate in older patients with partial-onset seizures: a pilot double-blind, dose-comparison study. Epilepsia 49: 1180-1185.
21. Sander JW,. (2004) The use of antiepileptic drugs-principles and practice. Epilepsia 45 (suppl 6): 28-34.
22. Snodgrass SR, Parks BR,. (2000) Anticonvulsant blood levels: historical review with a pediatric focus. J Child Neurol 15: 734-746.
23. Topamax. (2009) Prescribing information. Ortho-McNeil Neurologics, Raritan, NJ.
24. U.S. Food and Drug Administration. (2003) Guidance for Industry, Exposure-Response Relationships-Study Design, Data Analysis, and Regulatory Applications. U.S. Food and Drug Administration, Silver Spring, MD.