Pharmacokinetic considerations in chronic kidney disease and patients requiring dialysis

Bibliography

• Stevens PE, Levin A; Kidney Disease: Improving Global Outcomes Chronic Kidney Disease Guideline Development Work Group Members. Evaluation and management of chronic kidney disease: synopsis of the kidney disease: improving global outcomes 2012 clinical practice guideline. Ann Intern Med 2013;158:825-30
   PubMed Web of Science ®Google Scholar
• Cooper BA, Branley P, Bulfone L, IDEAL Study. A randomized, controlled trial of early versus late initiation of dialysis. N Engl J Med 2010;363:609-19
   PubMed Web of Science ®Google Scholar
• Nesrallah GE, Mustafa RA, Clark WF, et al. Canadian Society of Nephrology 2014 clinical practice guideline for timing the initiation of chronic dialysis. CMAJ 2014;186:112-17
   PubMed Web of Science ®Google Scholar
• Coresh J, Selvin E, Stevens LA, et al. Prevalence of chronic kidney disease in the United States. JAMA 2007;298:2038-47
   PubMed Web of Science ®Google Scholar
• Arora P, Vasa P, Brenner D, et al. Prevalence estimates of chronic kidney disease in Canada: results of a nationally representative survey. CMAJ 2013;185:E417-23
   PubMed Web of Science ®Google Scholar
• Manley HJ, Garvin CG, Drayer DK, et al. Medication prescribing patterns in ambulatory haemodialysis patients: comparisons of USRDS to a large not-for-profit dialysis provider. Nephrol dial transplant 2004;19:1842-8
   PubMed Web of Science ®Google Scholar
• Chiu YW, Teitelbaum I, Misra M, et al. Pill burden, adherence, hyperphosphatemia, and quality of life in maintenance dialysis patients. Clin J Am Soc Nephrol 2009;4:1089-96
   PubMed Web of Science ®Google Scholar
• Manley HJ, Cannella CA, Bailie GR, St Peter WL. Medication-related problems in ambulatory hemodialysis patients: a pooled analysis. Am J Kidney Dis 2005;46:669-80
   PubMed Web of Science ®Google Scholar
• Farag A, Garg AX, Li L, Jain AK. Dosing errors in prescribed antibiotics for older persons with CKD: a retrospective time series analysis. Am J Kidney Dis 2014;63:422-8
   PubMed Web of Science ®Google Scholar
• Bianchetti G, Graziani G, Brancaccio D, et al. Pharmacokinetics and effects of propranolol in terminal uraemic patients and in patients undergoing regular dialysis treatment. Clin pharmacokinet 1976;1:373-84
   PubMedGoogle Scholar
• De Martin S, Orlando R, Bertoli M, et al. Differential effect of chronic renal failure on the pharmacokinetics of lidocaine in patients receiving and not receiving hemodialysis. Clin Pharmacol Ther 2006;80:597-606
   PubMed Web of Science ®Google Scholar
• Dowling TC, Briglia AE, Fink JC, et al. Characterization of hepatic cytochrome p4503A activity in patients with end-stage renal disease. Clin.Pharmacol Ther 2003;73:427-34
   PubMed Web of Science ®Google Scholar
• Dreisbach AW, Japa S, Gebrekal AB, et al. Cytochrome P4502C9 activity in end-stage renal disease. Clin.Pharmacol Ther 2003;73:475-7
   PubMed Web of Science ®Google Scholar
• Marbury TC, Ruckle JL, Hatorp V, et al. Pharmacokinetics of repaglinide in subjects with renal impairment. Clin.Pharmacol Ther 2000;67:7-15
   PubMed Web of Science ®Google Scholar
• Nolin TD, Frye RF, Le P, et al. ESRD impairs nonrenal clearance of fexofenadine but not midazolam. J Am Soc Nephrol 2009;20:2269-76
   PubMed Web of Science ®Google Scholar
• Osborne R, Joel S, Grebenik K, et al. The pharmacokinetics of morphine and morphine glucuronides in kidney failure. Clin Pharmacol Ther 1993;54:158-67
   PubMed Web of Science ®Google Scholar
• Periclou A, Ventura D, Rao N, Abramowitz W. Pharmacokinetic study of memantine in healthy and renally impaired subjects. Clin Pharmacol Ther 2006;79:134-43
   PubMed Web of Science ®Google Scholar
• Sun H, Frassetto LA, Huang Y, Benet LZ. Hepatic clearance, but not gut availability, of erythromycin is altered in patients with end-stage renal disease. Clin Pharmacol Ther 2010;87:465-72
   PubMed Web of Science ®Google Scholar
• Uehlinger DE, Schaedeli F, Kinzig M, et al. Pharmacokinetics of fleroxacin after multiple oral dosing in patients receiving regular hemodialysis. Antimicrob Agents Chemother 1996;40:1903-9
   PubMed Web of Science ®Google Scholar
• 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;85:305-11
   PubMed Web of Science ®Google Scholar
• Guidance for industry. Pharmacokinetics in patients with impaired renal function - study design, data analysis, and impact on dosing and labelling. 2010. Available from: http://www.fda.gov/downloads/Drugs/Guidances/UCM204959.pdf [Last accessed 1 March 2014]
   Google Scholar
• Groschwitz KR, Hogan SP. Intestinal barrier function: molecular regulation and disease pathogenesis. J Allergy Clin Immunol 2009;124:3-20. quiz 21-22
   PubMed Web of Science ®Google Scholar
• Pappenheimer JR, Reiss KZ. Contribution of solvent drag through intercellular junctions to absorption of nutrients by the small intestine of the rat. J Membr Biol 1987;100:123-36
   PubMed Web of Science ®Google Scholar
• Ramezani A, Raj DS. The gut microbiome, kidney disease, and targeted interventions. J Am Soc Nephrol 2014;25:657-70
   PubMed Web of Science ®Google Scholar
• CDER/FDA. Guidance for industry: waiver of in vivo bioavailability and bioequivalence studies for immediate-release solid oral dosage forms based on a biopharmaceutics classification system. 2000. Available from: http://www.fda.gov/downloads/Drugs/Guidances/ucm070246.pdf [Last accessed 25 May 2014]
   Google Scholar
• Magnusson M, Magnusson KE, Sundqvist T, Denneberg T. Increased intestinal permeability to differently sized polyethylene glycols in uremic rats: effects of low- and high-protein diets. Nephron 1990;56:306-11
   PubMed Web of Science ®Google Scholar
• Magnusson M, Magnusson KE, Sundqvist T, Denneberg T. Impaired intestinal barrier function measured by differently sized polyethylene glycols in patients with chronic renal failure. Gut 1991;32:754-9
   PubMed Web of Science ®Google Scholar
• Vaziri ND, Yuan J, Rahimi A, et al. Disintegration of colonic epithelial tight junction in uremia: a likely cause of CKD-associated inflammation. Nephrol Dial Transplant 2012;27:2686-93
   PubMed Web of Science ®Google Scholar
• Vaziri ND, Yuan J, Khazaeli M, et al. Oral activated charcoal adsorbent (AST-120) ameliorates chronic kidney disease-induced intestinal epithelial barrier disruption. Am J Nephrol 2013;37:518-25
   PubMed Web of Science ®Google Scholar
• Sanaka T, Akizawa T, Koide K, Koshikawa S. Protective effect of an oral adsorbent on renal function in chronic renal failure: determinants of its efficacy in diabetic nephropathy. Ther Apher Dial 2004;8:232-40
   PubMed Web of Science ®Google Scholar
• Kikuchi K, Itoh Y, Tateoka R, et al. Metabolomic search for uremic toxins as indicators of the effect of an oral sorbent AST-120 by liquid chromatography/tandem mass spectrometry. J Chromatogr B Analyt Technol Biomed Life Sci 2010;878:2997-3002
   PubMed Web of Science ®Google Scholar
• Ho RH, Kim RB. Transporters and drug therapy: implications for drug disposition and disease. Clin Pharmacol Ther 2005;78:260-77
   PubMed Web of Science ®Google Scholar
• Glaeser H, Bailey DG, Dresser GK, et al. Intestinal drug transporter expression and the impact of grapefruit juice in humans. Clin pharmacol ther 2007;81:362-70
   PubMed Web of Science ®Google Scholar
• Naud J, Michaud J, Boisvert C, et al. Down-regulation of intestinal drug transporters in chronic renal failure in rats. J Pharmacol Exp Ther 2007;320:978-85
   PubMed Web of Science ®Google Scholar
• Leblond FA, Petrucci M, Dube P, et al. Downregulation of intestinal cytochrome p450 in chronic renal failure. J Am Soc Nephrol 2002;13:1579-85
   PubMed Web of Science ®Google Scholar
• Urquhart BL, Gregor JC, Chande N, et al. The Human Proton-Coupled Folate Transporter (hPCFT): modulation of Intestinal Expression and Function by Drugs. Am J Physiol Gastrointest Liver Physiol 2010;298:G248-54
   PubMed Web of Science ®Google Scholar
• Bukhari FJ, Moradi H, Gollapudi P, et al. Effect of chronic kidney disease on the expression of thiamin and folic acid transporters. Nephrol Dial Transplant 2011;26:2137-44
   PubMed Web of Science ®Google Scholar
• Steinman TI. Serum albumin: its significance in patients with ESRD. Semin Dial 2000;13:404-8
   PubMed Web of Science ®Google Scholar
• Vasson MP, Paul JL, Couderc R, et al. Serum alpha-1 acid glycoprotein in chronic renal failure and hemodialysis. Int J Artif Organs 1991;14:92-6
   PubMed Web of Science ®Google Scholar
• Moore DF, Rosenfeld MR, Gribbon PM, et al. Alpha-1-acid (AAG, orosomucoid) glycoprotein: interaction with bacterial lipopolysaccharide and protection from sepsis. Inflammation 1997;21:69-82
   PubMed Web of Science ®Google Scholar
• Sakai T, Yamasaki K, Sako T, et al. Interaction mechanism between indoxyl sulfate, a typical uremic toxin bound to site II, and ligands bound to site I of human serum albumin. Pharm Res 2001;18:520-4
   PubMed Web of Science ®Google Scholar
• Steele WH, Lawrence JR, Elliott HL, Whiting B. Alterations of phenytoin protein binding with in vivo haemodialysis in dialysis encephalopathy. Eur J Clin pharmacol 1979;15:69-71
   PubMed Web of Science ®Google Scholar
• Liponi DF, Winter ME, Tozer TN. Renal function and therapeutic concentrations of phenytoin. Neurology 1984;34:395-7
   PubMed Web of Science ®Google Scholar
• Dasgupta A, Abu-Alfa A. Increased free phenytoin concentrations in predialysis serum compared to postdialysis serum in patients with uremia treated with hemodialysis. Role of uremic compounds. Am J Clin Pathol 1992;98:19-25
   PubMed Web of Science ®Google Scholar
• Mabuchi H, Nakahashi H. A major inhibitor of phenytoin binding to serum protein in uremia. Nephron 1988;48:310-14
   PubMedGoogle Scholar
• Vanholder R, Van Landschoot N, De Smet R, et al. Drug protein binding in chronic renal failure: evaluation of nine drugs. Kidney Int 1988;33:996-1004
   PubMed Web of Science ®Google Scholar
• Jillella AP, Dainer PM, Kallab AM, Ustun C. Treatment of a patient with end-stage renal disease with Rituximab: pharmacokinetic evaluation suggests Rituximab is not eliminated by hemodialysis. Am J Hematol 2002;71:219-22
   PubMed Web of Science ®Google Scholar
• Wienkers LC, Heath TG. Predicting in vivo drug interactions from in vitro drug discovery data. Nat Rev Drug Discov 2005;4:825-33
   PubMed Web of Science ®Google Scholar
• Naud J, Nolin TD, Nolin FA, Nolin V. Current understanding of drug disposition in kidney disease. J Clin Pharmacol 2012;52:10S-22S
   PubMed Web of Science ®Google Scholar
• Nolin TD, Frye RF, Matzke GR. Hepatic drug metabolism and transport in patients with kidney disease. Am J Kidney Dis 2003;42:906-25
   PubMed Web of Science ®Google Scholar
• Nolin TD, Naud J, Leblond FA, Pichette V. Emerging evidence of the impact of kidney disease on drug metabolism and transport. Clin Pharmacol Ther 2008;83:898-903
   PubMed Web of Science ®Google Scholar
• Yeung CK, Shen DD, Thummel KE, Himmelfarb J. Effects of chronic kidney disease and uremia on hepatic drug metabolism and transport. Kidney Int 2013;85(3):522-8
   PubMed Web of Science ®Google Scholar
• Dreisbach AW, Lertora JJ. The effect of chronic renal failure on drug metabolism and transport. Expert Opin Drug Metab Toxicol 2008;4:1065-74
   PubMed Web of Science ®Google Scholar
• Zanger UM, Schwab M. Cytochrome P450 enzymes in drug metabolism: regulation of gene expression, enzyme activities, and impact of genetic variation. Pharmacol Ther 2013;138:103-41
   PubMed Web of Science ®Google Scholar
• Guevin C, Michaud J, Naud J, et al. Down-regulation of hepatic cytochrome p450 in chronic renal failure: role of uremic mediators. Br J Pharmacol 2002;137:1039-46
   PubMed Web of Science ®Google Scholar
• Leblond FA, Giroux L, Villeneuve JP, Pichette V. Decreased in vivo metabolism of drugs in chronic renal failure. Drug Metab Dispos 2000;28:1317-20
   PubMed Web of Science ®Google Scholar
• Simard E, Naud J, Michaud J, et al. Downregulation of hepatic acetylation of drugs in chronic renal failure. J Am Soc Nephrol 2008;19:1352-9
   PubMed Web of Science ®Google Scholar
• Velenosi TJ, Fu AY, Luo S, et al. Down-regulation of hepatic CYP3A and CYP2C mediated metabolism in rats with moderate chronic kidney disease. Drug Metab Dispos 2012;40:1508-14
   PubMed Web of Science ®Google Scholar
• Sun H, Huang Y, Frassetto L, Benet LZ. Effects of uremic toxins on hepatic uptake and metabolism of erythromycin. Drug Metab Dispos 2004;32:1239-46
   PubMed Web of Science ®Google Scholar
• Ahmed JH, Grant AC, Rodger RS, et al. Inhibitory effect of uraemia on the hepatic clearance and metabolism of nicardipine. Br J Clin Pharmacol 1991;32:57-62
   PubMed Web of Science ®Google Scholar
• De MS, Orlando R, Bertoli M, et al. Differential effect of chronic renal failure on the pharmacokinetics of lidocaine in patients receiving and not receiving hemodialysis. Clin Pharmacol Ther 2006;80:597-606
   PubMed Web of Science ®Google Scholar
• Dreisbach AW, Japa S, Gebrekal AB, et al. Cytochrome P4502C9 activity in end-stage renal disease. Clin Pharmacol Ther 2003;73:475-7
   PubMed Web of Science ®Google Scholar
• Limdi NA, Limdi MA, Cavallari L, et al. Warfarin dosing in patients with impaired kidney function. Am J Kidney Dis 2010;56:823-31
   PubMed Web of Science ®Google Scholar
• Gong IY, Schwarz UI, Crown N, et al. Clinical and genetic determinants of warfarin pharmacokinetics and pharmacodynamics during treatment initiation. PLoS One 2011;6:e27808
   PubMedGoogle Scholar
• Anttila M, Sotaniemi EA, Pelkonen O, Rautio A. Marked effect of liver and kidney function on the pharmacokinetics of selegiline. Clin Pharmacol Ther 2005;77:54-62
   PubMed Web of Science ®Google Scholar
• Brater DC. Drug dosing in patients with impaired renal function. Clin Pharmacol Ther 2009;86:483-9
   PubMed Web of Science ®Google Scholar
• Gabardi S, Abramson S. Drug dosing in chronic kidney disease. Med Clin North Am 2005;89:649-87
   PubMed Web of Science ®Google Scholar
• Lam YW, Banerji S, Hatfield C, Talbert RL. Principles of drug administration in renal insufficiency. Clin pharmacokinet 1997;32:30-57
   PubMed Web of Science ®Google Scholar
• Matzke GR, Aronoff GR, Atkinson AJ Jr, et al. Drug dosing consideration in patients with acute and chronic kidney disease-a clinical update from Kidney Disease: improving Global Outcomes (KDIGO). Kidney Int 2011;80:1122-37
   PubMed Web of Science ®Google Scholar
• Munar MY, Singh H. Drug dosing adjustments in patients with chronic kidney disease. Am Fam Physician 2007;75:1487-96
   PubMed Web of Science ®Google Scholar
• Verbeeck RK, Musuamba FT. Pharmacokinetics and dosage adjustment in patients with renal dysfunction. Eur J Clin Pharmacol 2009;65:757-73
   PubMed Web of Science ®Google Scholar
• Vlavonou R, Perreault MM, Barriere O, et al. Pharmacokinetic characterization of baclofen in patients with chronic kidney disease: dose adjustment recommendations. J Clin Pharmacol 2014. [ Epub ahead of print]
   PubMed Web of Science ®Google Scholar
• Shimomura K, Kamata O, Ueki S, et al. Analgesic effect of morphine glucuronides. Tohoku J Exp Med 1971;105:45-52
   PubMed Web of Science ®Google Scholar
• Osborne RJ, Joel SP, Slevin ML. Morphine intoxication in renal failure: the role of morphine-6-glucuronide. Br Med J (Clin Res Ed) 1986;292:1548-9
   PubMed Web of Science ®Google Scholar
• Naud J, Michaud J, Beauchemin S, et al. Effects of chronic renal failure on kidney drug transporters and cytochrome P450 in rats. Drug Metab Dispos 2011;39:1363-9
   PubMed Web of Science ®Google Scholar
• Akiyama Y, Kikuchi K, Saigusa D, et al. Indoxyl Sulfate Down-Regulates SLCO4C1 Transporter through Up-Regulation of GATA3. PLoS One 2013;8:e66518
   PubMed Web of Science ®Google Scholar
• Sakurai Y, Motohashi H, Ueo H, et al. Expression levels of renal organic anion transporters (OATs) and their correlation with anionic drug excretion in patients with renal diseases. Pharm Res 2004;21:61-7
   PubMed Web of Science ®Google Scholar
• Naud J, Michaud J, Leblond FA, et al. Effects of chronic renal failure on liver drug transporters. Drug Metab Dispos 2008;36:124-8
   PubMed Web of Science ®Google Scholar
• Fujita K, Sugiura T, Okumura H, et al. Direct inhibition and down-regulation by uremic plasma components of hepatic uptake transporter for SN-38, an active metabolite of irinotecan, in humans. Pharm Res 2014;31:204-15
   PubMed Web of Science ®Google Scholar
• Lee CS, Marbury TC, Benet LZ. Clearance calculations in hemodialysis: application to blood, plasma, and dialysate measurements for ethambutol. J Pharmacokinet Biopharm 1980;8:69-81
   PubMedGoogle Scholar
• Plum A, Jensen LB, Kristensen JB. In vitro protein binding of liraglutide in human plasma determined by reiterated stepwise equilibrium dialysis. J Pharm Sci 2013;102:2882-8
   PubMed Web of Science ®Google Scholar
• Pallotta KE, Manley HJ. Vancomycin use in patients requiring hemodialysis: a literature review. Semin Dial 2008;21:63-70
   PubMed Web of Science ®Google Scholar
• DeSoi CA, Sahm DF, Umans JG. Vancomycin elimination during high-flux hemodialysis: kinetic model and comparison of four membranes. Am J Kidney Dis 1992;20:354-60
   PubMed Web of Science ®Google Scholar
• Baillie GE, Mason NA. 2013 dialysis of drugs. Renal Pharmacy Consultants, LLC, Saline Michigan, USA 2013
   Google Scholar
• Bezzaoucha S, Merghoub A, Lamarche C, et al. Hemodialysis effects on phenytoin pharmacokinetics. Eur J Clin Pharmacol 2014;70:499-500
   PubMed Web of Science ®Google Scholar
• Amin NB, Padhi ID, Touchette MA, et al. Characterization of gentamicin pharmacokinetics in patients hemodialyzed with high-flux polysulfone membranes. Am J Kidney Dis 1999;34:222-7
   PubMed Web of Science ®Google Scholar
• Manley HJ, Bailie GR, McClaran ML, Bender WL. Gentamicin pharmacokinetics during slow daily home hemodialysis. Kidney Int 2003;63:1072-8
   PubMed Web of Science ®Google Scholar
• Watkins PB, Murray SA, Winkelman LG, et al. Erythromycin breath test as an assay of glucocorticoid-inducible liver cytochromes P-450. Studies in rats and patients. J Clin Invest 1989;83:688-97
   PubMed Web of Science ®Google Scholar
• Kurnik D, Wood AJ, Wilkinson GR. The erythromycin breath test reflects P-glycoprotein function independently of cytochrome P450 3A activity. Clin Pharmacol Ther 2006;80:228-34
   PubMed Web of Science ®Google Scholar
• Lancaster CS, Bruun GH, Peer CJ, et al. OATP1B1 polymorphism as a determinant of erythromycin disposition. Clin Pharmacol Ther 2012;92:642-50
   PubMed Web of Science ®Google Scholar
• Nolin TD, Appiah K, Kendrick SA, et al. Hemodialysis acutely improves hepatic CYP3A4 metabolic activity. J Am Soc Nephrol 2006;17:2363-7
   PubMed Web of Science ®Google Scholar
• Neirynck N, Vanholder R, Schepers E, et al. An update on uremic toxins. Int Urol Nephrol 2012;45(1):139-50
   PubMed Web of Science ®Google Scholar
• Vanholder R, De SR, Glorieux G, et al. Review on uremic toxins: classification, concentration, and interindividual variability. Kidney Int 2003;63:1934-43
   PubMed Web of Science ®Google Scholar
• Niemi M, Kivisto KT, Hofmann U, et al. Fexofenadine pharmacokinetics are associated with a polymorphism of the SLCO1B1 gene (encoding OATP1B1). Br J Clin Pharmacol 2005;59:602-4
   PubMed Web of Science ®Google Scholar
• Shimizu M, Fuse K, Okudaira K, et al. Contribution of OATP (organic anion-transporting polypeptide) family transporters to the hepatic uptake of fexofenadine in humans. Drug Metab Dispos 2005;33:1477-81
   PubMed Web of Science ®Google Scholar
• Cvetkovic M, Leake B, Fromm MF, et al. OATP and P-glycoprotein transporters mediate the cellular uptake and excretion of fexofenadine. Drug Metab Dispos 1999;27:866-71
   PubMed Web of Science ®Google Scholar
• Matsushima S, Maeda K, Hayashi H, et al. Involvement of multiple efflux transporters in hepatic disposition of fexofenadine. Mol Pharmacol 2008;73:1474-83
   PubMed Web of Science ®Google Scholar
• Birmingham BK, Swan SK, Puchalski T, et al. Pharmacokinetic and pharmacodynamic profile of rosuvastatin in patients with end-stage renal disease on chronic haemodialysis. Clin Drug Investig 2013;33:233-41
   PubMed Web of Science ®Google Scholar
• Bologa R, Levine D, Parker T, et al. Pharmacokinetics of rosuvastatin in patients with end-stage kidney disease undergoing peritoneal dialysis. Clin Nephrol 2009;72:437-41
   PubMed Web of Science ®Google Scholar
• Dostalek M, Court MH, Yan B, Akhlaghi F. Significantly reduced cytochrome P450 3A4 expression and activity in liver from humans with diabetes mellitus. Br J Pharmacol 2011;163:937-47
   PubMed Web of Science ®Google Scholar
• Parmar D, Srivastava SP, Seth PK. Age related effects of di(2-ethylhexyl)phthalate on hepatic cytochrome P450 monooxygenases in Wistar rats. Pharmacol Toxicol 1994;75:177-80
   PubMedGoogle Scholar
• KDIGO. KDIGO 2012 Clinical Practice Guideline for the Evaluation and Management of Chronic Kidney Disease. 2012. Available from: http://www.kdigo.org/clinical_practice_guidelines/pdf/CKD/KDIGO_2012_CKD_GL.pdf [Last accessed 1 March 2014]
   Google Scholar
• Inrig JK. Drug dosing in dialysis patients. (Curriculum AD. ed.). Available from: http://www.asn-online.org/education/distancelearning/curricula/dialysis/DrugDosingInrig.pdf [Last accessed 1 March 2014]
   Google Scholar