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Drug Evaluation

Pharmacokinetic and pharmacodynamic considerations on the erythropoietin effect and adverse events of darbepoetin

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Bibliography

  • Locatelli F, Del Vecchio L. An expert opinion on the current treatment ofanemia in patients with kidney disease. Expert Opin Pharmacother 2012;13:495-503
  • Pfeffer MA, Burdmann EA, Chen CY, et al. TREAT Investigators. A trial of darbepoetin alfa in type 2 diabetes and chronic kidney disease. N Engl J Med 2009;361:2019-32
  • Solomon SD, Uno H, Lewis EF, Trial to Reduce Cardiovascular Events with Aranesp Therapy (TREAT) Investigators. Erythropoietic response and outcomes in kidney disease and type 2 diabetes. N Engl J Med 2010;363:1146-55
  • Skali H, Parving HH, Parfrey PS, TREAT Investigators. Stroke in patients with type 2 diabetes mellitus, chronic kidney disease, and anemia treated with Darbepoetin Alfa: the trial to reduce cardiovascular events with Aranesp therapy (TREAT) experience. Circulation 2011;124:2903-8
  • Swedberg K, Young JB, Anand IS, RED-HF Committees; RED-HF Investigators. Treatment of anemia with darbepoetin alfa in systolic heart failure. N Engl J Med 2013;368:1210-19
  • Unger EF, Thompson AM, Blank MJ, Temple R. Erythropoiesis-stimulating agents–time for a reevaluation. N Engl J Med 2010;362:189-92
  • Macdougall IC, Padhi D, Jang G. Pharmacology of darbepoetin alfa. Nephrol Dial Transplant 2007;22(Suppl 4):iv2-9
  • Doshi S, Krzyzanski W, Yue S, et al. Clinical pharmacokinetics and pharmacodynamics of erythropoiesis-stimulating agents. Clin Pharmacokinet 2013;52:1063-83
  • Kim CD, Park SH, Kim DJ, et al. Randomized trial to compare the dosage of darbepoetin alfa by administration route in haemodialysis patients. Nephrology (Carlton) 2009;14:482-7
  • Krzyzanski W, Jusko WJ, Wacholtz MC, et al. Pharmacokinetic and pharmacodynamic modeling of recombinant human erythropoietin after multiple subcutaneous doses in healthy subjects. Eur J Pharm Sci 2005;26:295-306
  • Garrett ER. Simplified methods for the evaluation of the parameters of the time course of plasma concentration in the one-compartment body model with first-order invasion and first-order drug elimination including methods for ascertaining when such rate constants are equal. J Pharmacokinet Biopharm 1993;21:689-734. Erratum in J Pharmakinet Biopharm 1994;22:179
  • Doshi S, Chow A, Pérez Ruixo JJ. Exposure-response modeling of darbepoetin alfa in anemic patients with chronic kidney disease not receiving dialysis. J Clin Pharmacol 2010;50(9 Suppl):75S-90S
  • Agoram B, Heatherington AC, Gastonguay MR. Development and evaluation of a population pharmacokinetic-pharmacodynamic model of darbepoetin alfa in patients with nonmyeloid malignancies undergoing multicycle chemotherapy. AAPS J 2006;8:E552-63
  • Drüeke TB, Locatelli F, Clyne N, CREATE Investigators. Normalization of hemoglobin level in patients with chronic kidney disease and anemia. N Engl J Med 2006;355:2071-84
  • Singh AK, Szczech L, Tang KL, CHOIR Investigators. Correction of anemia with epoetin alfa in chronic kidney disease. N Engl J Med 2006;355:2085-98
  • Meibohm B, Derendorf H, Möllmann H, et al. Mechanism-based PK/PD model for the lymphocytopenia induced by endogenous and exogenous corticosteroids. Int J Clin Pharmacol Ther 1999;37:367-76
  • Hartmann B, Czock D, Keller F. Drug therapy in patients with chronic renal failure. Dtsch Arztebl Int 2010;107:647-56
  • Fujisaka Y, Tamura T, Ohe Y, et al. Pharmacokinetics and pharmacodynamics of weeklyepoetin beta in lung cancer patients. Jpn J Clin Oncol 2006;36:477-82
  • Ramakrishnan R, Cheung WK, Wacholtz MC, et al. Pharmacokinetic and pharmacodynamic modeling of recombinant human erythropoietin after single and multiple doses in healthy volunteers. J Clin Pharmacol 2004;44:991-1002
  • Besarab A, Flaharty KK, Erslev AJ, et al. Clinical pharmacology and economics of recombinant human erythropoietin in end-stage renal disease: the case for subcutaneous administration. J Am Soc Nephrol 1992;2:1405-16
  • Eyler RF, Mueller BA. Antibiotic pharmacokinetic and pharmacodynamic considerations in patients with kidney disease. Adv Chronic Kidney Dis 2010;17:392-403
  • Czock D, Keller F. Mechanism-based pharmacokinetic-pharmacodynamic modeling of antimicrobial drug effects. J Pharmacokinet Pharmacodyn 2007;34:727-51
  • Minutolo R, Conte G, Cianciaruso B, et al. Hyporesponsiveness to erythropoiesis-stimulating agents and renal survival in non-dialysis CKD patients. Nephrol Dial Transplant 2012;27:2880-6
  • Cotter D, Zhang Y, Thamer M, et al. The effect of epoetin dose on hematocrit. Kidney Int 2008;73:347-53
  • Brines M, Cerami A. Erythropoietin-mediated tissue protection: reducing collateral damage from the primary injury response. J Intern Med 2008;264:405-32
  • Agoram B, Sutjandra L, Sullivan JT. Population pharmacokinetics of darbepoetin alfa in healthy subjects. Br J Clin Pharmacol 2007;63:41-52
  • Aspinall SL, Cunningham FE, Zhao X, ESA Clinic Study Group. Impact of pharmacist-managed erythropoiesis-stimulating agents clinics for patients with non-dialysis-dependent CKD. Am J Kidney Dis 2012;60:371-9
  • Tonia T, Mettler A, Robert N, et al. Erythropoietin or darbepoetin for patients with cancer. Cochrane Database Syst Rev 2012;12:CD003407
  • Untch M, Fasching PA, Konecny GE, et al. Arbeitsgemeinschaft Gynäkologische Onkologie PREPARE investigators. PREPARE trial: a randomized phase III trial comparing preoperative, dose-dense, dose-intensified chemotherapy with epirubicin, paclitaxel and CMF versus a standard-dosed epirubicin/cyclophosphamide followed by paclitaxel ± darbepoetin alfa in primary breast cancer–results at the time of surgery. Ann Oncol 2011;22:1988-98
  • Najjar SS, Rao SV, Melloni C, REVEAL Investigators. Intravenous erythropoietin in patients with ST-segment elevation myocardial infarction: REVEAL: a randomized controlled trial. JAMA 2011;305:1863-72
  • Seliger SL, Zhang AD, Weir MR, et al. Erythropoiesis-stimulating agents increase the risk of acute stroke in patients with chronic kidney disease. Kidney Int 2011;80:288-94
  • Zhang Y, Thamer M, Kaufman JS, et al. High doses of epoetin do not lower mortality and cardiovascular risk among elderly hemodialysis patients with diabetes. Kidney Int 2011;80:663-9
  • Galle JC, Claes K, Kiss I, et al. An observational cohort study of extended dosing (once every 2 weeks or once monthly) regimens with darbepoetin alfa in patients with chronic kidney disease not on dialysis: the EXTEND study. Nephrol Dial Transplant 2012;27:2303-11
  • Bamgbola OF. Pattern of resistance to erythropoietin-stimulating agents in chronic kidney disease. Kidney Int 2011;80:464-74
  • Usberti M, Gerardi G, Bufano G, et al. Effects of erythropoietin and vitamin E-modified membrane on plasma oxidative stress markers and anemia of hemodialyzed patients. Am J Kidney Dis 2002;40:590-9
  • Szczech LA, Barnhart HX, Inrig JK, et al. Secondary analysis of the CHOIR trial epoetin-alpha dose and achieved hemoglobin outcomes. Kidney Int 2008;74:791-8
  • Lonnemann G, Wrenger E. Biosimilar epoetin zeta in nephrology: effect of injection frequency on weekly dose. Int J Clin Med 2012;3:598-602
  • Forni V, Bianchi G, Ogna A, et al. Reticulocyte dynamic and hemoglobin variability in hemodialysis patients treated with Darbepoetin alfa and C.E.R.A.: a randomized controlled trial. BMC Nephrol 2013;14:157-67

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