Effect of renal or hepatic impairment on the pharmacokinetics of mirabegron

Clinical Drug Investigation

Volumn 33, Issue 1, 2013, Pages 11-23

  Dickinson, James ^a   Lewand, Michaelene ^b   Sawamoto, Taiji ^b   Krauwinkel, Walter ^a   Schaddelee, Marloes ^a   Keirns, James ^b   Kerbusch, Virginie ^c   Moy, Selina ^b   Meijer, John ^a   Kowalski, Donna ^b   Morton, Richard ^d   Lasseter, Kenneth ^e   Riff, Dennis ^f   Kupčová, Viera ^g   Van Gelderen, Marcel ^a  

^a Astellas Pharma Global Development   (Netherlands)

^b ASTELLAS PHARMA GLOBAL DEVELOPMENT   (United States)

^c PharmAspire Consulting   (Netherlands)

^d Independent Statistician ^*  (United Kingdom)

^e Clinical Pharmacology of Miami Inc   (United States)

^f Advanced Clinical Research Institute   (United States)

^g UNIVERSITY HOSPITAL BRATISLAVA   (Slovakia)

Author keywords

[No Author keywords available]

Indexed keywords

DRUG METABOLITE; MIRABEGRON;

ADULT; AGED; AREA UNDER THE CURVE; ARTICLE; BODY MASS; CASE CONTROL STUDY; CHILD PUGH SCORE; CONTROLLED STUDY; DIARRHEA; DISEASE SEVERITY; DIZZINESS; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG EFFECT; DRUG ELIMINATION; DRUG HALF LIFE; DRUG INDUCED HEADACHE; DRUG PROTEIN BINDING; DRUG URINE LEVEL; ELECTROCARDIOGRAM; FEMALE; GLOMERULUS FILTRATION RATE; HEART PALPITATION; HUMAN; KIDNEY DYSFUNCTION; KIDNEY FUNCTION; LIVER DYSFUNCTION; LIVER FUNCTION; MAJOR CLINICAL STUDY; MALE; MAXIMUM PLASMA CONCENTRATION; NAUSEA; OPEN STUDY; PLASMA CONCENTRATION-TIME CURVE; PRIORITY JOURNAL; SIDE EFFECT; SINGLE DRUG DOSE;

ACETANILIDES; ADMINISTRATION, ORAL; ADRENERGIC BETA-3 RECEPTOR AGONISTS; ADULT; AGED; AREA UNDER CURVE; FEMALE; GLOMERULAR FILTRATION RATE; HALF-LIFE; HUMANS; KIDNEY; KIDNEY DISEASES; LIVER; LIVER DISEASES; MALE; METABOLIC CLEARANCE RATE; MIDDLE AGED; MODELS, BIOLOGICAL; SEVERITY OF ILLNESS INDEX; THIAZOLES;

EID: 84873045490     PISSN: 11732563     EISSN: 11791918     Source Type: Journal    
DOI: 10.1007/s40261-012-0031-3     Document Type: Article

References (26)

1. 3-adrenoceptor agonist, on bladder function. J Pharmacol Exp Ther. 2007;321(2):642-7.
2. Wein AJ, Rovner ES. Definition and epidemiology of overactive bladder. Urology. 2002;60(5 Suppl 1):7-12.
3. Abrams P, Cardozo L, Fall M, et al. The standardisation of terminology of lower urinary tract function: report from the Standardisation Sub-committee of the International Continence Society. Neurourol Urodyn. 2002;21:167-78.
4. Athanasopoulos A, Giannitsas K. An overview of the clinical use of antimuscarinics in the treatment of overactive bladder. Adv Urol. 2011;2011:820816.
5. Khullar V, Amarenco G, Angulo J, et al. Efficacy and tolerability of mirabegron, a β3-adrenoceptor agonist, in patients with overactive bladder: results from a randomized European-Australian Phase 3 trial. Eur Urol. Accepted.
6. Nitti V, Auerbach S, Martin N, et al. Results of a randomized phase III trial of mirabegron in patients with overactive bladder. J Urol. 2012. doi: 10.1016/j.juro.2012.10.017. (Epub ahead of print).
7. 3-adrenoceptor agonist, after oral administration to healthy male volunteers. Drug Metab Dispos. 2012;40(4):815-24.
8. Takusagawa S, Yajima K, Miyashita A, et al. Identification of human cytochrome P450 isoforms and esterases involved in the metabolism of mirabegron (YM178), a potent and selective β3-adrenoceptor agonist. Xenobiotica. 2012;42(10):957-67. doi: 10.3109/00498254.00492012.00675095.
9. Sawamoto T, Lee J, Alak A, et al. Phase I, open-label, drug interaction study to evaluate the effect of multiple doses of ketoconazole on single dose mirabegron (YM178) oral controlled absorption system (OCAS) in healthy adult subjects. Clin Pharmacol Ther. 2011;89(suppl. 1):S21. Abstr. PI-43.
10. van Gelderen E, Li Q, Meijer J, et al. An exploratory comparison of the single dose pharmacokinetics of the β3-adrenoceptor agonist mirabegron in healthy CYP2D6 poor and extensive metabolizers. Clin Pharmacol Ther. 2009;85(Suppl 1):S88.
11. Levey AS, Stevens LA, Schmid CH, et al. A new equation to estimate glomerular filtration rate. Ann Intern Med. 2009;150(9):604-12.
12. Stevens LA, Coresh J, Greene T, et al. Assessing kidney function-measured and estimated glomerular filtration rate. N Engl J Med. 2006;354(23):2473-83.
13. Cockcroft DW, Gault MH. Prediction of creatinine clearance from serum creatinine. Nephron. 1976;16(1):31-41.
14. Pugh RN, Murray-Lyon IM, Dawson JL, et al. Transection of the oesophagus for bleeding oesophageal varices. Br J Surg. 1973;60(8):646-9.
15. Center for Drug Evaluation and Research (CDER). Guidance for industry. Pharmacokinetics in patients with impaired hepatic function: study design, data analysis, and impact on dosing and labeling. 2003. http://www.fda.gov/downloads/ Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm072123.pdf. Accessed 7 Feb 2012.
16. Center for Drug Evaluation and Research (CDER). Draft guidance for industry. Pharmacokinetics in patients with impaired renal function: study design, data analysis, and impact on dosing and labeling (revision 1). 2010. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/ Guidances/UCM204959.pdf. Accessed 7 Feb 2012.
17. Committee for Medicinal Products for Human Use (CHMP) European Medicines Agency. Note for guidance on the evaluation of the pharmacokinetics of medicinal products in patients with impaired renal function (reference no. CHMP/EWP/225/02). 2004 Jun 23. http://www.ema.europa.eu/docs/en-GB/document- library/Scientific-guideline/2009/09/WC500003123.pdf. Accessed 7 Feb 2012.
18. Committee for Medicinal Products for Human Use (CHMP) European Medicines Agency. Guideline on the evaluation of the pharmacokinetics of medicinal products in patients with impaired hepatic function (reference no. CPMP/EWP/2339/02). 2005 Feb 17. http://www.tga.gov.au/pdf/euguide/ewp233902en. pdf. Accessed 7 Feb 2012.
19. van Teijlingen R, Meijer J, Takusagawa S, et al. Development and validation of LC-MS/MS methods for the determination of mirabegron and its metabolites in human plasma and their application to a clinical pharmacokinetic study. J Chromatogr B Analyt Technol Biomed Life Sci. 2012;887-888:102-11.
20. 3-adrenoceptor agonist for treatment of overactive bladder, in healthy subjects. Int J Clin Pharmacol Ther. 2012;50(11):838-50.
21. Dreisbach AW. The influence of chronic renal failure on drug metabolism and transport. Clin Pharmacol Ther. 2009;86(5):553-6.
22. Nolin TD, Naud J, Leblond FA, et al. Emerging evidence of the impact of kidney disease on drug metabolism and transport. Clin Pharmacol Ther. 2008;83(6):898-903.
23. Sun H, Frassetto L, Benet LZ. Effects of renal failure on drug transport and metabolism. Pharmacol Ther. 2006;109(1-2):1-11.
24. Zhang Y, Zhang L, Abraham S, et al. Assessment of the impact of renal impairment on systemic exposure of new molecular entities: evaluation of recent new drug applications. Clin Pharmacol Ther. 2009;85(3):305-11.
25. Data on file: Takusagawa S. Estimation of the major human plasma binding protein for YM178. Astellas Pharma Inc, Tokyo, Japan, 2004.
26. Data on file: Watanabe M, Ukai M, Ohtake A, et al. Agonist activities of YM178 and its metabolites for human Beta1- Beta2- or Beta3-adrenoceptors expressed in CHO cells. Astellas Pharma Inc, Tsukuba, Japan, 2007.