Кальцимиметики в лечении вторичного гиперпаратиреоза у диализных пациентов: сравнение эффективности и безопасности цинакальцета и этелкальцетида


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Аннотация

Вторичный гиперпаратиреоз (ВГПТ), часто встречающийся у пациентов, получающих поддерживающий диализ, связан с многочисленными неблагоприятными исходами, включая кальцификацию сосудов и клапанов, изменения в метаболизме костной ткани и повышенный риск сердечно-сосудистых заболеваний и смертности. Кальцимиметики - агенты, действующие на рецептор, чувствительный к кальцию (CaSR), разработаны для преодоления ограничений в использовании стеролов витамина D для лечения ВГПТ и продемонстрировали эффективность в снижении уровней ПТГ в рандомизированных исследованиях. Доступные в настоящее время кальцимиметики включают пероральный цинакальцет (ЦК) и недавно одобренный препарат для внутривенного введения этелкальцетид (эк). в то время как ЦК является аллостерическим модулятором CaSR, эк действует как прямой агонист CaSR. Свойства эк позволяют вводить его внутривенно 3 раза в неделю в конце сеанса лечения гемодиализом, что несомненно повышает приверженность терапии и снижает нагрузку применения таблетированных препаратов. в рандомизированных клинических исследованиях показано, что эк более эффективен, чем ЦК, в снижении уровня ПТГ, фосфатов, кальция, фактора роста фибробластов-23 (ФРФ-23). в этом обзоре сравниваются и сопоставляются фармакологические характеристики ЦК и эк, обсуждаются результаты клинических испытаний с участием этих препаратов и излагаются последствия их использования в клинической практике.

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Галина Владимировна Волгина

ФГБОУ во «Московский государственный медико-стоматологический университет им. А.И. Евдокимова» М3 РФ

Email: volginagv@mail.ru
д.м.н., профессор

Список литературы

  1. Moe S., Dru'eke T., Cunningham J. et al. Improving Global Outcomes (KDIGO): Definition, evaluation, and classification of renal osteodystrophy: A position statement from Kidney Disease: Improving Global Outcomes (KDIGO). Kidney Int. 2006; 69:1945-53.
  2. Kidney Disease: Improving Global Outcomes (KDIGO) CKD-MBD Update Work Group: KDIGO 2017 Clinical Practice Guideline Update for the Diagnosis, Evaluation, Prevention, and Treatment of Chronic Kidney Disease-Mineral and Bone Disorder (CKD-MBD). Kidney Int Suppl (2011). 2017; 7(1): 1-59. http://kdigo.org/wp-content/uploads/2017/02/2017-KDIGO-CKDMBD-GL-Update.pdf.
  3. Arbor Research Collaborative for Health. Dialysis Outcomes and Practice Patterns Study (DOPPS) Practice Monitor. Accessed on January 23, 2020. https://www.dopps.org/dpm
  4. Romagnani P., Remuzzi G., Glassock R. et al. Chronic kidney disease. Nat Rev Dis Primers. 2017;3:17088. https://doi.org/10.1038/nrdp.2017.88 PMID: 29168475
  5. Wanner C., Amann K., Shoji T. The heart and vascular system in dialysis. Lancet. 2016; 388(10041) :276-84. https://doi.org/10.1016/S0140-6736(16)30508-6 PMID: 27226133
  6. Hedgeman E., Lipworth L., Lowe K. et al. International burden of chronic kidney disease and secondary hyperparathyroidism: a systematic review of the literature and available data. Int J. Nephrol. 2015;2015:184321.
  7. Vervloet M.G. Chronic Kidney Disease-Mineral and Bone Disorder. Changing Insights Form Changing Parameters? Nephrol Dial Transplant. 2020; 35(3):385-389. https://doi.org/10.1093/ndt/gfz113Cunningham
  8. Portillo M.R., Rodriguez-Ortiz M.E. Secondary Hyperparthyroidism: Pathogenesis, Diagnosis, Preventive and Therapeutic Strategies. Rev Endocr Metab Disord. 2017;18(1):79-95.
  9. Isakova T., Wahl P., Vargas G.S. et al.: Fibroblast growth factor 23 is elevated before parathyroid hormone and phosphate in chronic kidney disease. Kidney Int. 2011; 79(12):1370-78.
  10. Munoz-Castaneda J.R., Herencia C., Pendon-Ruiz de Mier M.V. et al. Differential regulation of renal Klotho and FGFR1 in normal and uremic rats. FASEB J. 2017;31(9):3858-67.
  11. Canalejo R., Canalejo A., Martinez-Moreno J.M. et al. FGF23 Fails to Inhibit Uremic Parathyroid Glands. J. Am Soc Nephrol. 2010;21(7):1125-35.
  12. Kawakami K., Takeshita A., Furushima K. et al. Persistent fibroblast growth factor 23 signalling in the parathyroidglandsfor secondary hyperparathyroidism in mice with chronic kidney disease. Sci Rep. 2017;7:40534.
  13. Kan S., Zhang W., Mao J. et al. NF-kB activation contributes to parathyroid cell proliferation in chronic kidney disease. J. Nephrol. 2018;31(6):941-51.
  14. Centeno P.P., Herberger A., Mun H.C. et al. Phosphate acts directly on the calcium-sensing receptor to stimulate parathyroid hormone secretion. Nat Commun. 2019;10(1):4693. doi: 10.1038/s41467-019-12399-9
  15. Urakawa I., Yamazaki Y., Shimada T. et al. Klotho converts canonical ФРФ receptor into a specific receptor for ФРФ23. Nature. 2006;444(7120):770-74.
  16. Fan Y., Liu W., Bi R. et al. Interrelated role of Klotho and calcium-sensing receptor in parathyroid hormone synthesis and parathyroid hyperplasia. Proc Natl Acad Sci U. S. A. 2018; 115(16):E3749-58.
  17. Sadowski S.M., Pusztaszeri M., Brulhart-Meynet M.C. et al. Identification of Differential Transcriptional Patterns in Primary and Secondary Hyperparathyroidism. J. Clin Endocrinol Metab. 2018;103(6):2189-98.
  18. Shilo V., Mor-Yosef Levi I., Abel R. et al. Let-7 and Micr/RNA-148 Regulate Parathyroid Hormone Levels in Secondary Hyperparathyroidism. J. Am Soc Nephrol. 2017;28(8):2353-63.
  19. Tanaka M., Komaba H., Fukagawa M. Emerging association between parathyroid hormone and anemia in hemodialysis patients. Ther Apher Dial. 2018,22:242-45. doi: 10.1111/1744-9987.12685.
  20. Naylor K.L., Garg A.X., Zou G. et al. Comparison of fracture risk prediction among individuals with reduced and normal kidney function. Clin J. Am Soc Nephrol. 2015, 10:646-53. doi: 10.2215/CJN.06040614.
  21. Tentori F., McCullough K., Kilpatrick R.D. et al. High rates of death and hospitalization follow bone fracture among hemodialysis patients. Kidney Int. 2014, 85:166-73. 10.1038/ki.2013.279
  22. Chandran M., Wong J. Secondary and tertiary hyperparathyroidism in chronic kidney disease: an endocrine and renal perspective. Indian J. Endocrinol Metab. 2019;23:391-99. doi: 10.4103/ijem.IJEM_292_19.
  23. Kestenbaum B., Katz R., de Boer I. et al. Vitamin D., parathyroid hormone, and cardiovascular events among older adults. J. Am Coll Cardiol. 2011;58:1433- 41. doi: 10.1016/j.jacc.2011.03.069.
  24. Covic A., Kothawala P., Bernal M. et al. Systematic review of the evidence underlying the association between mineral metabolism disturbances and risk of all-cause mortality, cardiovascular mortality and cardiovascular events in chronic kidney disease. Nephrol Dial Transplant. 2009; 24:1506-23.
  25. Eknoyan G., Levin A., Levin N.W. Bone metabolism and disease in chronic kidney disease. Am J. Kidney Dis. 2003;42:1-201.
  26. Kidney Disease: Improving Global Outcomes (KDIGO) CKD-MBD Work Group. KDIGO clinical practice Guideline for the diagnosis, evaluation, prevention, and treatment of chronic kidney disease-mineral and bone disorder (CKD-MBD). Kidney Int Suppl 2009; 76 (Suppl 113): S1-130.
  27. Tentori F., Fuller D.S., Port F.K. et al. The DOPPS practice monitor for US dialysis care: potential impact of recent guidelines and regulatory changes on management of mineral and bone disorder among US hemodialysis patients. Am J. Kidney Dis. 2014;63(5):851-54.
  28. Aronoff G.R. Consider a step therapy approach for the treatment of hyperparathyroidism and mineral and bone disorder in patients on dialysis. Nephrol News Issues. 2019;33(07):20-3.
  29. Tentori F., Wang M., Bieber B.A. et al. Recent changes in therapeutic approaches and association with outcomes among patients with secondary hyperparathyroidism on chronic hemodialysis: the DOPPS study. Clin J. Am Soc Nephrol. 2015;10:98-10.
  30. Kalantar-Zadeh K., Kuwae N., Regidor D.L. et al. Survival predictability of time-varying indicators of bone disease in maintenance hemodialysis patients. Kidney Int. 2006;70(4):771- 80.
  31. Young E.W., Albert J.M., Satayathum S. et al. Predictors and consequences of altered mineral metabolism: The Dialysis Outcomes and Practice Patterns Study. Kidney Int. 2005;67:1179-87.
  32. Floege J., Kim J., Ireland E. et al. Serum iPTH, calcium and phosphate, and the risk of mortality in a European haemodialysis population. Nephrol Dial Transpl. 2011;26(6):1948-55. doi: 10.1093/ndt/gfq219.
  33. Naves-Diaz M., Passlick-Deetjen J., Guinsburg A. et al. Calcium, phosphorus, PTH and death rates in a large sample of dialysis patients from Latin America. The CORES Study. Nephrol Dial Transpl. 2011; 26(6):1938-47. doi: 10.1093/ndt/gfq301
  34. Fernandez-Martin J.L., Martinez-Camblor P., Dionisi М.Р. et al. Improvement of mineral and bone metabolism markers is associated with better survival in haemodialysis patients: the COSMOS study. Nephrol Dial Transpl. 2015;30(9):1542-51. doi: 10.1093/ndt/gfv099.
  35. Zhou X., Guo Y., Luo Y. The optimal range of serum intact parathyroid hormone for a lower risk of mortality in the incident hemodialysis patients. Ren Fail. 2021;43(1):599-605. doi: 10.1080/0886022X.2021.1903927.
  36. Ketteler M., Block G.A., Evenepoel P. et al. Executive summary of the 2017 KDIGO chronic kidney disease-mineral and bone disorder (CKD-MBD) guideline update: what’s changed and why it matters. Kidney Int. 2017;92(1):26-36.
  37. Asada S., Yokoyama K., Miyakoshi C. et al. Relationship between serum calcium or phosphate levels and mortality stratified by parathyroid hormone level: an analysisfrom the MBD-5Dstudy. Clin Exp Nephrol. 2020;24(7):630-37.
  38. Kato C., Fujii N., Miyakoshi C. et al. Changes in 3-month mineral and bone disorder patterns were associated with all-cause mortality in prevalent hemodialysis patients with secondary hyperparathyroidism. BMC Nephrol. 2020; 21(1):432. doi: 10.1186/s12882-020-02088-x.
  39. Tabibzadeh N., Karaboyas A., Robinson B.M. et al. The risk of medically uncontrolled secondary hyperparathyroidism depends on parathyroid hormone levels at haemodialysis initiation. Nephrol Dial Transplant. 2021;36(1):160- 69.
  40. Brown E.M., Gamba G., Riccardi D. et al.: Cloning and characterization of an extracellular Ca(2+)-sensing receptor from bovine parathyroid. Nature. 1993;366(6455):575-80.
  41. Cunningham J., Locatelli F., Rodriguez M. Secondary hyperparathyroidism: pathogenesis, disease progression, and therapeutic options. Clin J. Am Soc Nephrol. 2011;6(4):913-21. https://doi.org/10.2215/ CJN.06040710 PMID: 21454719
  42. Lopez I., Aguilera-Tejero E., Mendoza F.J. et al. Calcimimetic R-568 Decreases Extraosseous Calcifications in Uremic Rats Treated with Calcitriol. J. Am Soc Nephrol. 2006;17(3):795-804.
  43. Lopez I., Mendoza F.J., Guerrero F. et al. The calcimimetic AMG 641 accelerates regression of extraosseous calcification in uremic rats. Am J. Physiol Renal Physiol. 2009; 96(6):F1376-85.
  44. Goodman W.G., Quarles L.D. Development and progression of secondary hyperparathyroidism in chronic kidney disease: Lessons from molecular genetics. Kidney Int. 2008;74(3):276-88. https://doi.org/10.1038/sj.ki.5002287 PMID: 17568787
  45. Levin A., Bakris G.L., Molitch M. et al. Prevalence of abnormal serum vitamin D., PTH, calcium, and phosphorus in patients with chronic kidney disease: results of the study to evaluate early kidney disease. Kidney Int. 2007;71(1):31-38. 17091124' target='_blank'>https://d/i./r7Q10.1038/sj.ki.S002009PMID: 17091124
  46. Block G.A., Martin K.J., de Francisco A.L.M. et al. Cinacalcet for Secondary Hyperparathyroidism in Patients Receiving Hemodialysis. N. Engl J. Med.2004;350(15):1516-25.
  47. Lindberg J.S., Culleton B., Wong G. et al.: Cinacalcet HCl, an oral calcimimetic agent for the treatment of secondary hyperparathyroidism in hemodialysis and peritoneal dialysis: a randomized, double-blind, multicenter study. J. Am Soc Nephrol. 2005; 16(3): 800- 7.
  48. Zitt E., Fouque D., Jacobson S.H. et al. Serum phosphorus reduction in dialysis patients treated with cinacalcet for secondary hyperparathyroidism results mainly from parathyroid hormone reduction. Clin Kidney J. 2013;6(3):287-94.
  49. Li D., Shao L., Zhou H. et al. The efficacy of cinacalcet combined with conventional therapy on bone and mineral metabolism in dialysis patients with secondary hyperparathyroidism: a meta-analysis. Endocrine. 2013;43(1): 68- 77.
  50. Zhang Q., Li M., You L. et al. Effects and safety of calcimimetics in end stage renal disease patients with secondary hyperparathyroidism: a meta-analysis. PLoS One. 2012; 7(10):e48070.
  51. Raggi P., Chertow G.M., Torres P.U. et al. The ADVANCE study: a randomized study to evaluate the effects of cinacalcet plus low-dose vitamin D. on vascular calcification in patients on hemodialysis. Nephrol Dial Transplant. 2011;26(4):1327-39.
  52. Urena-Torres P.A., Floege J., Hawley C.M. et al. Protocol adherence and the progression of cardiovascular calcification in the ADVANCE study. Nephrol Dial Transplant. 2013;28(1):146-152.
  53. Bellasi A., Reiner M., Petavy F. et al. Presence of valvular calcifcation predicts the response to cinacalcet: data from the ADVANCE study. J. Heart Valve Dis. 2013; 22:391-99.
  54. EVOLVE Trial Investigators Effect of cinacalcet on cardiovascular disease in patients undergoing dialysis. N. Engl J. Med. 2012;367(26):2482-94.
  55. Parfrey P.S., Drueke T.B., Block G.A. et al. The Efects of cinacalcet in older and younger patients on hemodialysis: the evaluation of cinacalcet HCl therapy to lower cardiovascular events (EVOLVE) trial. Clin J. Am Soc Nephrol 2015; 10:791-99.
  56. Pasch A., Block G.A., Bachtler M. et al. Blood calcifcation propensity, cardiovascular events, and survival in patients receiving hemodialysis in the EVOLVE trial. Clin J. Am Soc Nephrol. 2017;12:315-22.
  57. Floege J., Kubo Y., Floege A. et al. The Efect of cinacalcet on calcifc uremic arteriolopathy events in patients receiving hemodialysis: the EVOLVE Trial. Clin J. Am Soc Nephrol 2015; 10:800-807.
  58. Wheeler D.C., London G.M., Parfrey P.S. et al. Effects of cinacalcet on atherosclerotic and nonatherosclerotic cardiovascular events in patients receiving hemodialysis: the Evaluation of Cinacalcet HCl Therapy to Lower CardioVascular Events (EVOLVE) trial. J. Am Heart Assoc. 2014; 3:e001363.
  59. Moe S.M., Chertow G.M., Parfrey PS. et al.: Cinacalcet, Fibroblast Growth Factor-23, and Cardiovascular Disease in Hemodialysis: The Evaluation of Cinacalcet HCl Therapy to Lower Cardiovascular Events (EVOLVE) Trial. Circulation. 2015;132(1):27-39.
  60. Tsuruta Y., Okano K., Kikuchi K. et al. Effects of cinacalcet on bone mineral density and bone markers in hemodialysis patients with secondary hyperparathyroidism. Clin Exp Nephrol. 2013; 17(1):120-26.
  61. Parfrey P.S., Chertow G.M., Block G.A. et al. The clinical course of treated hyperparathyroidism among patients receiving hemodialysis and the effect of cinacalcet: the EVOLVE trial. J. Clin Endocrinol Metab. 2013;98(12): 4834-44.
  62. Diaz-Tocados J.M., Rodriguez-Ortiz M.E., Almaden Y. et al. Calcimimetics maintain bone turnover in uremic rats despite the concomitant decrease in parathyroid hormone concentration. Kidney Int. 2019; 95(5):1064-78.
  63. Zitt E., Rix M., Torres P.U. et al. Effectiveness of cinacalcet in patients with recurrent/persistent secondary hyperparathyroidism fo2llowing parathyroidectomy: results of the ECHO study. Nephrol Dial Transplant. 2011;26(6):1956-61.
  64. Edson K.Z., Wu B.M., Iyer A. et al. Determination of etelcalcetide biotransformation and hemodialysis kinetics to guide the timing of its dosing. Kidney Int. 2016;1(1):24-33.
  65. Wu L., Melhem M., Subramanian R., Wu B. Drug disposition model of radiolabeled etelcalcetide in patients with chronic kidney disease and secondary hyperparathyroidism on hemodialysis. J. Pharmacokinet Pharmacodyn. 2017;44(1):43-53
  66. Martin K.J., Bell G., Pickthorn K. et al. Velcalcetide (AMG 416), a novel peptide agonist of the calcium-sensing receptor, reduces serum parathyroid hormone and ФРФ23 levels in healthy male subjects. Nephrol Dial Transplant. 2014;29(2):385-92.
  67. Martin K.J., Pickthorn K., Huang S. et al. AMG 416 (velcalcetide) is a novel peptide for the treatment of secondary hyperparathyroidism in a single-dose study in hemodialysis patients. Kidney Int. 2014;85(1):191-97.
  68. Subramanian R., Zhu X., Hock B. et al. Pharmacokinetics, biotransformation, and excretion of [14C] etelcalcetide (AMG 416) following a single microtracer intravenous dose in patients with chronic kidney disease on hemodialysis. Clin Pharmacokinet. 2017;56(2):179-92. PMID: 27517676
  69. Subramanian R., Zhu X., Kerr S.J. et al. Nonclinical pharmacokinetics disposition, and drug-drug interaction potential of a novel D-amino acid peptide agonist of the calcium sensing receptor AMG 416 (etelcalcetide). Drug Metab Dispos. 2016;44(8):1319-31. PMID: 26895981
  70. Block G.A., Bushinsky D.A., Cheng S. et al. Effect of etelcalcetide vs cinacalcet on serum parathyroid hormone in patients receiving hemodialysis with secondary hyperparathyroidism: A randomized clinical trial. JAMA. 2017;317(2): 156-64. https://doi.org/10.1001/jama.2016.19468 PMID: 28097356
  71. Block G.A., Bushinsky D.A., Cunningham J. et al. Effect of etelcalcetide vs placebo on serum parathyroid hormone in patients receiving hemodialysis with secondary hyperparathyroidism: two randomized clinical trials. JAMA. 2017;317(2): 146-55. https://doi.org/10.1001/jama.2016.19456 PMID: 28097355
  72. Fukagawa M., Yokoyama K., Shigematsu T. et al. A phase 3, multicentre, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of etelcalcetide (ONO-5163/AMG 416), a novel intravenous calcimimetic, for secondary hyperparathyroidism in Japanese haemodialysis patients. Nephrol Dial Transplant. 2017;32(10):1723-30.
  73. Block G.A., Chertow G.M. Dosing of etelcalcetide vs cinacalcet for secondary hyperparathyroidism-reply. JAMA. 2017;317:2132-33.
  74. Palmer S.C., Mavridis D., Johnson D.W. et al. Comparative effectiveness of calcimimetic agents for secondary hyperparathyroidism in adults: a systematic review and network meta-analysis. Am J. Kidney Dis. 2020; 76(3):321-30. doi: 10.1053/j.ajkd.2020.02.439.
  75. Shigematsu T., Fukagawa M., Yokoyama K., et al.: Long-term effects of etelcalcetide as intravenous calcimimetic therapy in hemodialysis patients with secondary hyperparathyroidism. Clin Exp Nephrol. 2018;22(2):426-36.
  76. Russo D., Tripepi R., Malberti F. et al. Etelcalcetide in Patients on Hemodialysis with Severe Secondary Hyperparathyroidism. Multicenter Study in “Real Life”. J. Clin Med. 2019;8(7):1066.
  77. Cunningham J., Block G.A., Chertow G.M. et al.: Etelcalcetide Is Effective at All Levels of Severity of Secondary Hyperparathyroidism in Hemodialysis Patients. Kidney Int Rep. 2019; 4(7): 987-94.
  78. Xipell M., Montagud-Marrahi E., Rubio M.V. et al. Improved control of secondary hyperparathyroidism in hemodialysis patients switching from Oral Cinacalcet to intravenous Etelcalcetide, especially in nonadherent patients. Blood Purif. 2019;48(2):106-14.
  79. Arenas M.D., Rodelo-Haad C., de Mier M.V.P., Rodriguez M. Control of hyperparathyroidism with the intravenous calcimimetic etelcalcetide in dialysis patients adherent and non-adherent to oral calcimimetics. Clin Kidney J. 2020; 14: 840-46. doi: 10.1093/ckj/sfaa005.
  80. Stephens J.M., Fox K.M., Desai P. Calcimimetic use in US hemodialysis facilities in first 2 years after the launch of etelcalcetide: A descriptive analysis of real-world clinical practice and outcomes. Hemodialysis International. 2021;1-12. Wiley on line library.com/journal/hdi doi: 10.1111/hdi.12996.
  81. Kurokawa Y., Kaida Y., Hazama T. et al. Effect of switching from cinacalcet to etelcalcetide on secondary hyperparathyroidism in patients undergoing hemodialysis: an ESCORT trial. Ren Replace Ther. 2020;6(1):64.
  82. Rottembourg J., Urena-Torres P., Toledano D.et al. Factors associated with parathyroid hormone control in haemodialysis patients with secondary hyperparathyroidism treated with cinacalcet in real-world clinical practice: Mimosa study. Clin Kidney J. 2019;12:871-79.
  83. Karaboyas A., Muenz D., Fuller D.S. et al. Etelcalcetide Utilization, Dosing Titration, and Chronic Kidney Disease-Mineral and Bone Disease (CKD-MBD) Marker Responses in US Hemodialysis Patients. Am J. Kidney Dis. XX (XX):1-12. Published online July 14, 2021. doi: 10.1053/j.ajkd.2021.05.020.
  84. Bushinsky D.A., Chertow G.M., Cheng S. et al. One-year safety and efficacy of intravenous etelcalcetide in patients on hemodialysis with secondary hyperparathyroidism. Nephrol Dial Transplant. 2019;1-10.
  85. Parsabiv (etelcalcetide) injection, for intravenous use [package insert]. KAI Pharmaceuticals Inc/Amgen; 2017. https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208325Orig1s000Lbledt.pdf
  86. Shigematsu T., Fukagawa M., Yokoyama K. et al. Effects of the Intravenous Calcimimetic Etelcalcetide on Bone Turnover and Serum Fibroblast Growth Factor 23: Post Hoc Analysis of an Open-label Study. Clin Ther. 2018;40(12):2099-111.
  87. Bell G., Huang S., Martin K.J., Block G.A. A randomized, double-blind, phase 2 study evaluating the safety and efficacy of AMG 416 for the treatment of secondary hyperparathyroidism in hemodialysis patients. Curr Med Res Opin. 2015;31(5):943-52
  88. Wolf M., Block G.A., Chertow G.M. et al. Effects of etelcalcetide on fibroblast growth factor 23 in patients with secondary hyperparathyroidism receiving hemodialysis. Clinical Kidney Journal 2020, 13 (1):75-84. doi: 10.1093/ckj/ sfz034
  89. Dorr К., Kammer М., Reindl-Schwaighofer R. et al. Randomized Trial of Etelcalcetide for Cardiac Hypertrophy in Hemodialysis. Circ Res. 2021;128(11):1616-25
  90. doi: 10.1161/CIRCRESAHA.120.318556
  91. Yu L., Tomlinson J.E., Alexander S.T. et al. Etelcalcetide, a novel calcimimetic, prevents vascular calcification in a rat model of renal insufficiency with secondary hyperparathyroidism. Calcif Tissue Int. 2017;101(6):641-53.
  92. Behets G.J., Spasovski G., Sterling L.R. et al. Bone histomorphometry before and after long-term treatment with cinacalcet in dialysis patients with secondary hyperparathyroidism. Kidney Int. 2015;87(4):846-56. PMID: 25337774
  93. Moe S.M., Abdalla S., Chertow G.M. et al. Effects of cinacalcet on fracture events in patients receiving hemodialysis: the EVOLVE trial. J. Am Soc Nephrol. 2015;26(6):1466-75. PMID: 25505257
  94. Rottembourg J., Ure-na-Torres P., Toledano D. et al. Factors associated with parathyroid hormone control in haemodialysis patients with secondary hyperparathyroidism treated with cinacalcet in real-world clinical practice: Mimosa study. Clinical Kidney Journal, 2019,1-9. doi: 10.1093/ckj/sfz021.
  95. Fielden M.R., Dean C. Jr, Black K. et al. Nonclinical safety profile of etelcalcetide, a novel peptide calcimimetic for the treatment of secondary hyperparathyroidism. Int J. Toxicol. 2016; 35(3):294-308. PMID: 26941242.
  96. Amgen Inc. Swiss summary of the risk management plan (RMP) for Parsabiv (etelcalcetide), Zug, Switzerland.2017 [cited 2018 February22].www.ema.europa.eu/docs/en_GB/document_library/.../WC500217125.pdf
  97. De Geest S., Sabate E. Adherence to long-term therapies: evidence for action. Eur J. Cardiovasc Nurs. 2003;2(4):323. doi: 10.1016/S1474-5151(03)00091-4.
  98. Fuller D.S., Hallett D., Dluzniewski P.J.et al. Predictors of cinacalcet discontinuation and reinitiation in hemodialysis patients: results from 7 European countries. BMC Nephrol. 2019;20:169.
  99. Kilpatrick R.D., Newsome B.B., Zaun D. et al. Evaluating real-world use of cinacalcet and biochemical response to therapy in U.S. hemodialysis patients. Am J. Nephrol. 2013;37:389-98.
  100. Reams B.D., Dluzniewski P.J., Do T.P. et al. Dynamics of cinacalcet use and biochemical control in hemodialysis patients: a retrospective new-user cohort design. BMC Nephrol. 2015;16:175.
  101. Gincherman Y., Moloney K., McKee C., Coyne D.W. Assessment of adherence to cinacalcet by prescription refill rates in hemodialysis patients. Hemodial Int. 2010;14(1):68-72.
  102. Lee A., Song X., Khan I. et al. Association of cinacalcet adherence and costs in patients on dialysis. J. Med Econ. 2011;14(6):798-804.
  103. Park H., Rascati K.L., Lawson K.A. et al. Adherence and persistence to prescribed medication therapy among Medicare part D. beneficiaries on dialysis: comparisons of benefit type and benefit phase. J. Manag Care Spec Pharm. 2014;20(8):862-76.
  104. Chiu Y.W., 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(6): 1089-1096.
  105. Burnier M., Pruijm M., Wuerzner G. et al. Drug adherence in chronic kidney diseases and dialysis. Nephrol Dial Transplant 2015;30:39-44.
  106. Friedl C., Zitt E. Role of etelcalcetide in the management of secondary hyperparathyroidism in hemodialysis patients: a review on current data and place in therapy. Drug Des Devel Ther. 2018;12:1589-98
  107. Roggeri A., Conte F., Rossi C. et al. Cinacalcet adherence in dialysis patients with secondary hyperparathyroidism in Lombardy Region: clinical implications and costs.Drugs Context. 2020;9:2020-2021-1.
  108. Cunningham J., Danese M., Olson K. et al. Effects of the calcimimetic cinacalcet HCl on cardiovascular disease, fracture, and health-related quality of life in secondary hyperparathyroidism. Kidney Int. 2005;68(4):1793-800. https://doi.org/10.1111/j.1523-1755.2005.00596.x PMID: 16164656
  109. van der Plas W.Y., Dulfer R.R., Engelsman A.F. et al. Effect ofparathyroidectomy and cinacalcet on quality of life in patients with end-stage renal disease-related hyperparathyroidism: a systematic review. Nephrol Dial Transplant. 2017;32(11):1902-1908.
  110. Ghimire S., Castelino R.L., Lioufas N.M. et al. Nonadherence to medication therapy in haemodialysis patients: a systematic review. PLoS One. 2015;10(12):e0144119.
  111. Ge Y., Yang G., Wang N. et al. Bone metabolism markers and hungry bone syndrome after parathyroidectomy in dialysis patients with secondary hyperparathyroidism. Int Urol Nephrol. 2019; 51(1):1443-49.
  112. Ivarsson K.M., Akaberi S., Isaksson E. et al. Cardiovascular and cerebrovascular events after Parathyroidectomy in patients on renal replacement therapy. World J. Surg. 2019;43(8):1981-88.
  113. Chertow G.M., Block G.A., Correa-Rotter R. et al. Effect of cinacalcet on cardiovascular disease in patients undergoing dialysis. N. Engl J. Med. 2012;367(26):2482-94. https://doi.org/10.1056/NEJMoa1205624 PMID: 23121374
  114. Block G.A., Chertow G.M., Sullivan J.T. et al. An integrated analysis of safety and tolerability of etelcalcetide in patients receiving hemodialysis with secondary hyperparathyroidism. PLoS ONE. 2019:14(3): e0213774. https://doi.org/10.1371/journal.pone.0213774
  115. Block G.A., Martin K.J., de Francisco A.L. et al. Cinacalcet for secondary hyperparathyroidism in patients receiving hemodialysis. N. Engl J. Med. 2004; 350(15):1516-25.
  116. Floege J., Tsirtsonis K., Iles J. et al. Incidence, predictors and therapeutic consequences of hypocalcemia in patients treated with cinacalcet in the EVOLVE trial. Kidney Int. 2018 Mar 7; Epub.
  117. Middleton J.P., Wolf M. Second chances to improve ESRD outcomes with a second-generation calcimimetic. JAMA. 2017;317:139-41.

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