Brivaracetam disposition in mild to severe hepatic impairment

Journal of Clinical Pharmacology

Volumn 53, Issue 6, 2013, Pages 633-641

  Stockis, Armel ^a   Sargentini Maier, Maria Laura ^a   Horsmans, Yves ^b  

^a UCB PHARMA   (Belgium)

^b CLINIQUES UNIVERSITAIRES SAINT LUC   (Belgium)

Author keywords

Anticonvulsants; Brivaracetam; Epilepsy; Hepatic insufficiency; Pharmacokinetics; Ucb 34714

Indexed keywords

ACID; BRIVARACETAM; CYTOCHROME P450; DRUG METABOLITE; HYDROXYACID;

ADULT; AGED; ARTICLE; BLOOD SAMPLING; CHILD PUGH SCORE; CLINICAL ARTICLE; CONTROLLED STUDY; CREATININE CLEARANCE; DISEASE SEVERITY; DRUG DISPOSITION; DRUG SAFETY; DRUG TOLERABILITY; DRUG TRANSFORMATION; FEMALE; HUMAN; HYDROXYLATION; KIDNEY FUNCTION; LIVER BLOOD FLOW; LIVER DYSFUNCTION; LIVER FUNCTION TEST; LIVER METABOLISM; MALE; OPEN STUDY; SINGLE DRUG DOSE; URINALYSIS;

ADMINISTRATION, ORAL; ADULT; AGED; ANTICONVULSANTS; AREA UNDER CURVE; CASE-CONTROL STUDIES; CYTOCHROME P-450 ENZYME SYSTEM; FEMALE; HALF-LIFE; HUMANS; HYDROXYLATION; LIVER DISEASES; LIVER FUNCTION TESTS; MALE; MEMBRANE GLYCOPROTEINS; MIDDLE AGED; NERVE TISSUE PROTEINS; PYRROLIDINONES; SEVERITY OF ILLNESS INDEX;

EID: 84880301593     PISSN: 00912700     EISSN: 15524604     Source Type: Journal    
DOI: 10.1002/jcph.82     Document Type: Article

References (29)

1. Bialer M, Johannessen SI, Levy RH, Perucca E, Tomson T, White HS. Progress report on new antiepileptic drugs: a summary of the Tenth Eilat Conference (EILAT X). Epilepsy Res. 2010;92:89-124.
2. Kenda BM, Matagne AC, Talaga PE, et al. Discovery of 4 substituted pyrrolidone butanamides as new agents with significant antiepileptic activity. J Med Chem. 2004;47:530-549.
3. Zona C, Pieri M, Carunchio I, Curcio L, Klitgaard H, Margineanu D G. Brivaracetam (ucb 34714) inhibits Na+ current in rat cortical neurons in culture. Epilepsy Res. 2010;88:46-54.
4. Matagne A, Margineanu D G, Kenda B, Michel P, Klitgaard H. Anti convulsive and anti epileptic properties of brivaracetam (ucb 34714), a high affinity ligand for the synaptic vesicle protein, SV2A. Br J Pharmacol. 2008;154:1662-1671.
5. Kaminski RM, Matagne A, Klitgaard H. Protective effects of brivaracetam in phenytoin resistant amygdala kindled mice: a comparison with levetiracetam. Epilepsia. 2009;50(Suppl 10):5. Abstract 015.
6. Kasteleijn Nolst Trenite DG, Genton P, Parain D, et al. Evaluation of brivaracetam, a novel SV2A ligand, in the photosensitivity model. Neurology. 2007;69:1027-1034.
7. French JA, Costantini C, Brodsky A, von Rosenstiel P. Adjunctive brivaracetam for refractory partial onset seizures: a randomized, controlled trial. Neurology. 2010;75:519-525.
8. Van Paesschen W, Hirsch E, Johnson M, Falter U, von Rosenstiel P. Efficacy and tolerability of adjunctive brivaracetam in adults with uncontrolled partial onset seizures: a phase IIb, randomized, controlled trial. Epilepsia. 2013;54:89-97.
9. Rolan P, Sargentini Maier ML, Pigeolet E, Stockis A. The pharmacokinetics, CNS pharmacodynamics and adverse event profile of brivaracetam after multiple increasing oral doses in healthy males. Br J Clin Pharmacol. 2008;66:71-75.
10. Sargentini Maier ML, Rolan P, Connell J, et al. The pharmacokinetics, CNS pharmacodynamics and adverse event profile of brivaracetam after single increasing oral doses in healthy males. Br J Clin Pharmacol. 2007;63:680-688.
11. Sargentini Maier ML, Espie P, Coquette A, Stockis A. Pharmacokinetics and metabolism of 14C brivaracetam, a novel SV2A ligand, in healthy subjects. Drug Metab Dispos. 2008;36:36-45.
12. Lacroix B, von Rosenstiel P, Sargentini Maier M L. Population pharmacokinetics of brivaracetam in patients with partial epilepsy. Epilepsia. 2007;48(Suppl 6):333.
13. von Rosenstiel P, Perucca E. Brivaracetam. In: Shorvon S, Perucca E, Engel J, Jr., eds. The Treatment of Epilepsy. 3rd ed. Chichester: Wiley Blackwell; 2009:447-457.
14. Verbeeck RK. Pharmacokinetics and dosage adjustment in patients with hepatic dysfunction. Eur J Clin Pharmacol. 2008;64: 1147-1161.
15. Molino G, Cavanna A, Avagnina P, Ballare M, Torchio M. Hepatic clearance of D sorbitol. Noninvasive test for evaluating functional liver plasma flow. Dig Dis Sci. 1987;32:753-758.
16. Pugh RN, Murray Lyon IM, Dawson JL, Pietroni MC, Williams R. Transection of the oesophagus for bleeding oesophageal varices. Br J Surg. 1973;60:646-649.
17. Kerr WC, Stockwell T. Understanding standard drinks and drinking guidelines. Drug Alcohol Rev. 2012;31:200-205.
18. Echizen H, Ohta Y, Shirataki H, et al. Effects of subchronic treatment with natural human interferons on antipyrine clearance and liver function in patients with chronic hepatitis. J Clin Pharmacol. 1990;30:562-567.
19. Baririan N, Van Obbergh L, Desager JP, et al. Alfentanil induced miosis as a surrogate measure of alfentanil pharmacokinetics in patients with mild and moderate liver cirrhosis. Clin Pharmacokinet. 2007;46:261-270.
20. Brockmoller J, Thomsen T, Wittstock M, Coupez R, Lochs H, Roots I. Pharmacokinetics of levetiracetam in patients with moderate to severe liver cirrhosis (Child Pugh classes A, B, and C): characterization by dynamic liver function tests. Clin Pharmacol Ther. 2005;77:529-541.
21. Sargentini Maier ML, Sokalski A, Boulanger P, Jacobs T, Stockis A. Brivaracetam disposition in renal impairment. J Clin Pharmacol. 2012;52:1927-1933.
22. Strolin Benedetti M, Whomsley R, Nicolas JM, Young C, Baltes E. Pharmacokinetics and metabolism of 14C levetiracetam, a new antiepileptic agent, in healthy volunteers. Eur J Clin Pharmacol. 2003;59:621-630.
23. Nicolas JM, Chanteux H, Rosa M, Watanabe S, Stockis A. Effect of gemfibrozil on the metabolism of brivaracetam in vitro and in human subjects. Drug Metab Dispos. 2012;40:1466-1472.
24. Frye RF, Zgheib NK, Matzke GR, et al. Liver disease selectively modulates cytochrome P450-mediated metabolism. Clin Pharmacol Ther. 2006;80:235-245.
25. Areberg J, Christophersen JS, Poulsen MN, Larsen F, Molz KH. The pharmacokinetics of escitalopram in patients with hepatic impairment. AAPS J. 2006;8:E14-E19.
26. Pique JM, Feu F, de PG, Rohss K, Hasselgren G. Pharmacokinetics of omeprazole given by continuous intravenous infusion to patients with varying degrees of hepatic dysfunction. Clin Pharmacokinet. 2002;41:999-1004.
27. Marcellin P, deBF,GarretC, et al. Influence of cirrhosis onlamotrigine pharmacokinetics. Br J Clin Pharmacol. 2001;51:410-414.
28. Patsalos PN. Clinical pharmacokinetics of levetiracetam. Clin Pharmacokinet. 2004;43:707-724.
29. FDA. Guidance for industry. Pharmacokinetics in patients with impaired hepatic function: Study design, data analysis, and impact on dosing and labeling. May 2003. Available at: http://www.fda.gov/downloads/Drugs/ GuidanceComplianceRegulatoryInformation/Guidances/ucm072123.pdf. Accessed 7 December 2012.