Population pharmacokinetics and therapeutic efficacy of febuxostat in patients with severe renal impairment

Pharmacology

Volumn 96, Issue 1-2, 2015, Pages 90-98

  Hira, Daiki ^a   Chisaki, Yugo ^c   Noda, Satoshi ^a   Araki, Hisazumi ^b   Uzu, Takashi ^b   Maegawa, Hiroshi ^b   Yano, Yoshitaka ^c   Morita, Shin Ya ^a   Terada, Tomohiro ^a  

^a SHIGA UNIVERSITY OF MEDICAL SCIENCE HOSPITAL   (Japan)

^b SHIGA UNIVERSITY OF MEDICAL SCIENCE   (Japan)

^c KYOTO PHARMACEUTICAL UNIVERSITY   (Japan)

Author keywords

Chronic kidney disease; Febuxostat; Hemodialysis; Population pharmacokinetics; Renal function

Indexed keywords

ALLOPURINOL; FEBUXOSTAT; ANTIGOUT AGENT;

ADULT; AGED; ARTICLE; BODY WEIGHT; CLINICAL ARTICLE; COMPARTMENT MODEL; DRUG ABSORPTION; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG EFFICACY; DRUG SUBSTITUTION; ELECTRONIC MEDICAL RECORD; FEMALE; GLOMERULUS FILTRATION RATE; GOUT; HUMAN; HYPERURICEMIA; KIDNEY FUNCTION; LIMIT OF QUANTITATION; MALE; PRESCRIPTION; PRIORITY JOURNAL; RETROSPECTIVE STUDY; SEVERE RENAL IMPAIRMENT; TREATMENT RESPONSE; VOLUME OF DISTRIBUTION; BLOOD; CLINICAL TRIAL; COMPLICATION; MIDDLE AGED; RENAL INSUFFICIENCY; VERY ELDERLY;

ADULT; AGED; AGED, 80 AND OVER; FEBUXOSTAT; FEMALE; GOUT SUPPRESSANTS; HUMANS; HYPERURICEMIA; MALE; MIDDLE AGED; RENAL INSUFFICIENCY; RETROSPECTIVE STUDIES;

EID: 84937781693     PISSN: 00317012     EISSN: 14230313     Source Type: Journal    
DOI: 10.1159/000434633     Document Type: Article

References (29)

1. Campion EW, Glynn RJ, DeLabry LO: Asymptomatic hyperuricemia. Risks and consequences in the normative aging study. Am J Med 1987; 82: 421-426.
2. Roubenoff R, Klag MJ, Mead LA, Liang KY, Seidler AJ, Hochberg MC: Incidence and risk factors for gout in white men. JAMA 1991; 266: 3004-3007.
3. Dahlöf B, Devereux RB, Kjeldsen SE, Julius S, Beevers G, de Faire U, Fyhrquist F, Ibsen H, Kristiansson K, Lederballe-Pedersen O, Lindholm LH, Nieminen MS, Omvik P, Oparil S, Wedel H; LIFE Study Group: Cardiovascular morbidity and mortality in the losartan intervention for endpoint reduction in hypertension study (LIFE): a randomised trial against atenolol. Lancet 2002; 359: 995-1003.
4. Høieggen A, Alderman MH, Kjeldsen SE, Julius S, Devereux RB, De Faire U, Fyhrquist F, Ibsen H, Kristianson K, Lederballe-Pedersen O, Lindholm LH, Nieminen MS, Omvik P, Oparil S, Wedel H, Chen C, Dahlöf B; LIFE Study Group: The impact of serum uric acid on cardiovascular outcomes in the life study. Kidney Int 2004; 65: 1041-1049.
5. Shoji A, Yamanaka H, Kamatani N: A retrospective study of the relationship between serum urate level and recurrent attacks of gouty arthritis: evidence for reduction of recurrent gouty arthritis with antihyperuricemic therapy. Arthritis Rheum 2004; 51: 321-325.
6. Stamp LK, O'Donnell JL, Zhang M, James J, Frampton C, Barclay ML, Chapman PT: Using allopurinol above the dose based on creatinine clearance is effective and safe in patients with chronic gout, including those with renal impairment. Arthritis Rheum 2011; 63: 412-421.
7. Dalbeth N, Kumar S, Stamp L, Gow P: Dose adjustment of allopurinol according to creatinine clearance does not provide adequate control of hyperuricemia in patients with gout. J Rheumatol 2006; 33: 1646-1650.
8. Becker MA, Schumacher HR Jr, Wortmann RL, MacDonald PA, Eustace D, Palo WA, Streit J, Joseph-Ridge N: Febuxostat compared with allopurinol in patients with hyperuricemia and gout. N Engl J Med 2005; 353: 2450-2461.
9. Takano Y, Hase-Aoki K, Horiuchi H, Zhao L, Kasahara Y, Kondo S, Becker MA: Selectivity of febuxostat, a novel non-purine inhibitor of xanthine oxidase/xanthine dehydrogenase. Life Sci 2005; 76: 1835-1847.
10. Mukoyoshi M, Nishimura S, Hoshide S, Umeda S, Kanou M, Taniguchi K, Muroga H: In vitro drug-drug interaction studies with febuxostat, a novel non-purine selective inhibitor of xanthine oxidase: plasma protein binding, identification of metabolic enzymes and cytochrome P450 inhibition. Xenobiotica 2008; 38: 496-510.
11. Hosoya T, Ohno I: A repeated oral administration study of febuxostat (TMX-67), a nonpurine-selective inhibitor of xanthine oxidase, in patients with impaired renal function in Japan: pharmacokinetic and pharmacodynamic study. J Clin Rheumatol 2011; 17(4 suppl 2):S27-S34.
12. Tausche AK, Wunderlich C, Aringer M: Tophaceous gout and renal insufficiency: a new solution for an old therapeutic dilemma. Case Rep Med 2011; 2011: 397646.
13. Mizuno T, Hayashi T, Hikosaka S, Shimabukuro Y, Murase M, Takahashi K, Hayashi H, Yuzawa Y, Nagamatsu T, Yamada S: Efficacy and safety of febuxostat in elderly female patients. Clin Interv Aging 2014; 9: 1489-1493.
14. Whelton A, MacDonald PA, Chefo S, Gunawardhana L: Preservation of renal function during gout treatment with febuxostat: a quantitative study. Postgrad Med 2013; 125: 106-114.
15. Sakai Y, Otsuka T, Ohno D, Murasawa T, Sato N, Tsuruoka S: Febuxostat for treating allopurinol-resistant hyperuricemia in patients with chronic kidney disease. Ren Fail 2014; 36: 225-231.
16. Curiel RV, Guzman NJ: Challenges associated with the management of gouty arthritis in patients with chronic kidney disease: a systematic review. Semin Arthritis Rheum 2012; 42: 166-178.
17. Matsuo S, Imai E, Horio M, Yasuda Y, Tomita K, Nitta K, Yamagata K, Tomino Y, Yokoyama H, Hishida A; Collaborators developing the Japanese equation for estimated GFR: Revised equations for estimated GFR from serum creatinine in Japan. Am J Kidney Dis 2009; 53: 982-992.
18. Naranjo CA, Busto U, Sellers EM, Sandor P, Ruiz I, Roberts EA, Janecek E, Domecq C, Greenblatt DJ: A method for estimating the probability of adverse drug reactions. Clin Pharmacol Ther 1981; 30: 239-245.
19. Keizer RJ, Karlsson MO, Hooker A: Modeling and simulation workbench for NONMEM: tutorial on pirana, PsN, and Xpose. CPT Pharmacometrics Syst Pharmacol 2013; 2:e50.
20. Wählby U, Jonsson EN, Karlsson MO: Comparison of stepwise covariate model building strategies in population pharmacokineticpharmacodynamic analysis. AAPS PharmSci 2002; 4:E27.
21. Khosravan R, Grabowski BA, Wu JT, Joseph-Ridge N, Vernillet L: Pharmacokinetics, pharmacodynamics and safety of febuxostat, a non-purine selective inhibitor of xanthine oxidase, in a dose escalation study in healthy subjects. Clin Pharmacokinet 2006; 45: 821-841.
22. Beal SL: Ways to fit a PK model with some data below the quantification limit. J Pharmacokinet Pharmacodyn 2001; 28: 481-504.
23. Khosravan R, Kukulka MJ, Wu JT, Joseph-Ridge N, Vernillet L: The effect of age and gender on pharmacokinetics, pharmacodynamics, and safety of febuxostat, a novel nonpurine selective inhibitor of xanthine oxidase. J Clin Pharmacol 2008; 48: 1014-1024.
24. Becker MA, MacDonald PA, Hunt B, Gunawardhana L: Treating hyperuricemia of gout: safety and efficacy of febuxostat and allopurinol in older versus younger subjects. Nucleosides Nucleotides Nucleic Acids 2011; 30: 1011-1017.
25. Khosravan R, Grabowski BA, Mayer MD, Wu JT, Joseph-Ridge N, Vernillet L: The effect of mild and moderate hepatic impairment on pharmacokinetics, pharmacodynamics, and safety of febuxostat, a novel nonpurine selective inhibitor of xanthine oxidase. J Clin Pharmacol 2006; 46: 88-102.
26. Mayer MD, Khosravan R, Vernillet L, Wu JT, Joseph-Ridge N, Mulford DJ: Pharmacokinetics and pharmacodynamics of febuxostat, a new non-purine selective inhibitor of xanthine oxidase in subjects with renal impairment. Am J Ther 2005; 12: 22-34.
27. Savic RM, Karlsson MO: Importance of shrinkage in empirical bayes estimates for diagnostics: problems and solutions. AAPS J 2009; 11: 558-569.
28. Ohno I, Ichida K, Okabe H, Hikita M, Uetake D, Kimura H, Saikawa H, Hosoya T: Frequency of gouty arthritis in patients with end-stage renal disease in Japan. Intern Med 2005; 44: 706-709.
29. Tsuruta Y, Mochizuki T, Moriyama T, Itabashi M, Takei T, Tsuchiya K, Nitta K: Switching from allopurinol to febuxostat for the treatment of hyperuricemia and renal function in patients with chronic kidney disease. Clin Rheumatol 2014; 33: 1643-1648.