Cinacalcet: An oral calcimimetic agent for the management of hyperparathyroidism

Clinical Therapeutics

Volumn 27, Issue 11, 2005, Pages 1725-1751

  Dong, Betty J ^a  

^a UNIVERSITY OF CALIFORNIA   (United States)

Author keywords

Calcimimetic; Cinacalcet; Parathyroid carcinoma; Primary hyperparathyroidism; Secondary hyperparathyroidism

Indexed keywords

CALCIMIMETIC AGENT; CINACALCET; PARATHYROID HORMONE;

ABDOMINAL PAIN; AREA UNDER THE CURVE; ARTICLE; ASTHENIA; CALCIUM BLOOD LEVEL; CLINICAL TRIAL; DIARRHEA; DRUG EFFICACY; DRUG SAFETY; GASTROINTESTINAL TOXICITY; HEADACHE; HUMAN; HYPERPARATHYROIDISM; HYPOCALCEMIA; HYPOTENSION; MEDLINE; NAUSEA; NONHUMAN; QUALITY CONTROL; SIDE EFFECT; TREATMENT OUTCOME; UPPER RESPIRATORY TRACT INFECTION; VOMITING;

ANIMALS; AREA UNDER CURVE; CALCIUM; CLINICAL TRIALS, PHASE II; CLINICAL TRIALS, PHASE III; DRUG INTERACTIONS; HALF-LIFE; HUMANS; HYPERPARATHYROIDISM, PRIMARY; HYPERPARATHYROIDISM, SECONDARY; KIDNEY FAILURE, CHRONIC; KIDNEY TRANSPLANTATION; NAPHTHALENES; PARATHYROID HORMONE; PARATHYROID NEOPLASMS; PHOSPHORUS; RANDOMIZED CONTROLLED TRIALS; RENAL DIALYSIS;

EID: 29144433541     PISSN: 01492918     EISSN: 1879114X     Source Type: Journal    
DOI: 10.1016/j.clinthera.2005.11.015     Document Type: Article

References (69)

1. Wood C., Gonzalez E.A., and Martin K.J. Challenges in the therapy of secondary hyperparathyroidism Ther Apher Dial 9 2005 4 8
2. Shoback D.M., Bilezikian J.P., and Turner S.A. The calcimimetic cinacalcet normalizes serum calcium in subjects with primary hyperparathyroidism J Clin Endocrinol Metab 88 2003 5644 5649
3. Shane E. Clinical review 122: Parathyroid carcinoma J Clin Endocrinol Metab 86 2001 485 493
4. Martinez I., Saracho R., Montenegro J., and Llach F. The importance of dietary calcium and phosphorus in the secondary hyperparathyroidism of patients with early renal failure AmJ Kidney Dis 29 1997 496 502
5. Block G.A., Hulbert-Shearon T.E., Levin N.W., and Port F.K. Association of serum phosphorus and calcium x phosphate product with mortality risk in chronic hemodialysis patients: A national study Am J Kidney Dis 31 1998 607 617
6. Ganesh S.K., Stack A.G., and Levin N.W. Association of elevated serum PO(4), Ca x PO(4) product, and parathyroid hormone with cardiac mortality risk in chronic hemodialysis patients J Am Soc Nephrol 12 2001 2131 2138
7. Block G.A., Klassen P.S., and Lazarus J.M. Mineral metabolism, mortality, and morbidity in maintenance hemodialysis J Am Soc Nephrol 15 2004 2208 2218
8. Hruska K.A., and Teitelbaum S.L. Renal osteodystrophy N Engl J Med 333 1995 166 174
9. Parfitt A.M. Renal bone disease: A new conceptual framework for the interpretation of bone histomorphometry Curr Opin Nephrol Hypertens 12 2003 387 403
10. Lisbon, Portugal. Abstract 5026. Available at: Kim J., Dylan M., and Doan Q. Association of elevated serum parathyroid hormone (PTH) and calcium with risk of hip, vertebral, or pelvic fracture in hemodialysis patients Accessed April 24, 2005 Presented at: 41 st Congress of the European Renal Association and the European Dialysis and Transplant Association May 15-18 2004
11. Goodman W.G., Goldin J., and Kuizon B.D. Coronary-artery calcification in young adults with end-stage renal disease who are undergoing dialysis N Engl J Med 342 2000 1478 1483
12. Moe S.M., and Drueke T.B. Management of secondary hyperparathyroidism: The importance and the challenge of controlling parathyroid hormone levels without elevating calcium, phosphorus, and calcium-phosphorus product Am J Nephrol 23 2003 369 379
13. National Kidney Foundation K/DOQI clinical practice guidelines for bone metabolism and disease in chronic kidney disease Am J Kidney Dis 42 Suppl 4 2003 S1 5201
14. Moe S.M., Chertow G.M., and Coburn J.W. Achieving NKFK/DOQI bone metabolism and disease treatment goals with cinacalcet HCl Kidney Int 67 2005 760 771
15. Abstract Kim J., Pisoni R.L., and Danese M.D. Achievement of proposed NKF-K/DOQI bone metabolism and disease guidelines: Results from the dialysis outcomes and practice pattern study (DOPPS) J Am Soc Nephrol 13 2003 270A
16. Tfelt-Hansen J., and Brown E.M. The calcium sensing receptor in normal physiology and pathophysiology: A review Crit Rev Clin Lab Sci 42 2005 35 70
17. Rodriguez M., Nemeth E., and Martin D. The calcium-sensing receptor: A key factor in the pathogenesis of secondary hyperparathyroidism Am J Physiol Renal Physiol 288 2005 F253 F264
18. Sensipar [package insert] 2004 Amgen Inc Thousand Oaks, Calif.
19. Peacock M., Bilezikian J.P., and Klassen P.S. Cinacalcet hydrochloride maintains long-term normocalcemia in patients with primary hyperparathyroidism J Clin Endocrinol Metab 90 2005 135 141
20. Charytan C., Coburn J.W., and Chonchol M. Cinacalcet hydrochloride is an effective treatment for secondary hyperparathyroidism in patients with CKD not receiving dialysis Am J Kidney Dis 46 2005 58 67
21. Serra A.L., Schwarz A.A., and Wick F.H. Successful treatment of hypercalcemia with cinacalcet in renal transplant recipients with persistent hyperparathyroidism Nephrol Dial Transplant 20 2005 1315 1319
22. Kruse A.E., Eisenberger U., Frey F.J., and Mohaupt M.G. The calcimimetic cinacalcet normalizes serum calcium in renal transplant patients with persistent hyperparathyroidism Nephrol Dial Transplant 20 2005 1311 1314
23. Nemeth E.F., Steffey M.E., and Hammerland L.G. Calcimimetics with potent and selective activity on the parathyroid calcium receptor Proc Natl Acad Sci U S A 95 1998 4040 4045
24. Nemeth E.F. Calcimimetic and calcilytic drugs: Just for parathyroid cells? Cell Calcium 35 2004 283 289
25. Cohen A., and Silverberg S.J. Calcimimetics: Therapeutic potential in hyperparathyroidism Curr Opin Pharmacol 2 2002 734 739
26. Nemeth E.F., Heaton W.H., and Miller M. Pharmacodynamics of the type II calcimimetic compound cinacalcet HCl J Pharmacol Exp Ther 308 2004 627 635
27. Colloton M., Shatzen E., and Miller G. Cinacalcet HCl attenuates parathyroid hyperplasia in a rat model of secondary hyperparathyroidism Kidney Int 67 2005 467 476
28. Henley C., Colloton M., and Cattley R.C. 1,25-Dihydroxyvitamin D3 but not cinacalcet HCl (Sensipar/Mimpara) treatment mediates aortic calcification in a rat model of secondary hyperparathyroidism Nephrol Dial Transplant 20 2005 1370 1377
29. Ohashi N., Uematsu T., and Nagashima S. The calcimimetic agent KRN 1493 lowers plasma parathyroid hormone and ionized calcium concentrations in patients with chronic renal failure on haemodialysis both on the day of haemodialysis and on the day without haemodialysis Br J Clin Pharmacol 57 2004 726 734
30. Abstract PII-40 Wang B., Ludden T., and Gonzalez B.S. A population pharmacokinetic (PK) and pharmacodynamic (PD) analysis of cinacalcet HCl in renal-dialysis patients with secondary hyperparathyroidism(HPT) Clin Pharmacol Ther 75 2004 P62
31. Abstract PIII-107 Wang B., Osborn K., and Blaisdell P. Pharmacokinetics (PK) of calcimimetic AMG073 in secondary hyper-parathyroidism (SHPT) Clin Pharmacol Ther 69 2001 P91
32. Kumar G.N., Sproul C., and Poppe L. Metabolism and disposition of calcimimetic agent cinacalcet HCl in humans and animal models Drug Metab Dispos 32 2004 1491 1500
33. Harris R.Z., Padhi D., and Marbury T.C. Pharmacokinetics, pharmacodynamics, and safety of cinacalcet hydrochloride in hemodialysis patients at doses up to 200 mg once daily Am J Kidney Dis 44 2004 1070 1076
34. Padhi D., Harris R.Z., Salfi M., and Sullivan J.T. No effect of renal function or dialysis on pharmacokinetics of cinacalcet (Sensipar/Mimpara) Clin Pharmacokinet 44 2005 509 516
35. Abstract 423 Nakashima D., Kitahori M., and Hayashi K. In vitro metabolism of cinacalcet HCl (AMG073/KRN1493), a new calcimimetic agent, in human liver microsomes and cytochrome P450 isoforms Drug Metab Rev 36 2004 211
36. Abstract M476 Harris R., Padhi D., and Salfi M. The impact of hepatic impairment on the pharmacokinetics of cinacalcet HCl Nephrol Dial Transplant 18 Suppl 4 2003 149
37. Goodman W.G., Hladik G.A., and Turner S.A. The calcimimetic agent AMG 073 lowers plasma parathyroid hormone levels in hemodialysis patients with secondary hyperparathyroidism J Am Soc Nephrol 13 2002 1017 1024
38. Lindberg J.S., Moe S.M., and Goodman W.G. The calcimimetic AMG 073 reduces parathyroid hormone and calcium x phosphorus in secondary hyperparathyroidism Kidney Int 63 2003 248 254
39. Quarles L.D., Sherrard D.J., and Adler S. The calcimimetic AMG 073 as a potential treatment for secondary hyperparathyroidism of end-stage renal disease J Am Soc Nephrol 14 2003 575 583
40. Abstract SA-P0753 Moe S.M., Cunningham J., and Bommer j. Long-term treatment of secondary hyperparathyroidism with the calcimimetic cinacalcet HCl J Am Soc Nephrol 14 2003 463A
41. Abstract M479 Cunningham J., Holzer H., and Reichel H. Sustained, long-term reductions in parathyroid hormone (PTH) after 3 years of treatment with the calcimimetic cinacalcet HCl in patients withsecondary hyperparathyroidism (SHPT) Nephrol Dial Transplant 18 Suppl 4 2003 150
42. Urena Torres P. Clinical experience with cinacalcet HCl Nephrol Dial Transplant 19 Suppl 5 2004 V27 V33
43. Abstract M480 Urena P., Legoupil N., and de Vemejoul M.C. Sustained control of uremic secondary hyperparathyroidism after three years of treatment with the calcimimetic cinacalcet HCl: A single center experience Nephrol Dial Transplant 18 Suppl 4 2003 151
44. Block G.A., Martin K.J., and de Francisco A.L. Cinacalcet for secondary hyperparathyroidism in patients receiving hemodialysis N Engl J Med 350 2004 1516 1525
45. Abstract SA-P0743 Block G.A., Martin K.J., and Turner S.A. Phase 3 study results demonstrate efficacy and safety of the calcimimetic cinacalcet HCl in hemodialysis patients with secondary hyperparathyroidism (HPT) J Am Soc Nephrol 14 2003 461A
46. Abstract SA-P0742 de Francisco A.L.M., Suranyi M., and Cunningham J. Oral cinacalcet HCl (AMG 073) for the treatment of hemodialysis patients with secondary hyperparathyroidism (HPT): Results of a European/Australianphase 3 study J Am Soc Nephrol 14 2003 461A
47. Lindberg J.S., Culleton B., and Wong G. 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 16 2005 800 807
48. St. Louis, Mo. Abstract F-P098. Available at: Mittman N., Finkelstein F., and Culleton B. Cinacalcet HCl (Sensipar™) for the management of secondary hyperparathyroidism (HPT) in patients receiving peritoneal dialysis (PD) Accessed March 25, 2005 Presented at: American Society of Nephrology Renal Week October 29-November 1 2004
49. St. Louis, Mo. Abstract PUB477. Available at: Goodman W.G., de Francisco A.L.M., and Mittman N. Cinacalcet HCl (Sensipar™) effectively manages secondary hyperparathyroidism in new to dialysis patients Accessed March 25, 2005 Presented at: American Society of Nephrology Renal Week October 29-November 1 2004
50. St. Louis, Mo. Abstract F-P0984. Available at: Goodman W.G., de Francisco A.L.M., and Moe S.M. Cinacalcet HCl (Sensipar™) is an effective treatment for secondary hyperparathyroidism (HPT) in CKD patients on dialysis Accessed March 25, 2005 Presented at: American Society of Nephrology Renal Week October 29-November 1 2004
51. St. Louis, Mo. Abstract F-P0964. Available at: Sterrett J.R., Strom J., and Stummvoll H.K. Long-term treatment of secondary hyperparathyroidism (HPT) with cinacalcet HCl (Sensipar™) in patients receiving dialysis Accessed March 25, 2005 Presented at: American Society of Nephrology Renal Week October 29-November 1 2004
52. St. Louis, Mo. Abstract SA-P0989. Available at: Sprague S.M., Nicolini M., and Evenepoel P. Maintenance of NKF-K/DOQITM goals for parathyroid hor mone and Ca x P with cinacalcet HCl Accessed March 25, 2005 Presented at: American Society of Nephrology Renal Week October 29-November 1 2004
53. Abstract SA-P0754 Coyne D.W., Stegman M.H., and Azad H. Cinacalcet HCl controls secondary hyperparathyroidism (HPT) regardless of gender, race, age, and geography in patients with chronic kidney disease (CKD) receiving dialysis J Am Soc Nephrol 14 2003 464A
54. Abstract SA-P0751 Quarles L.I.D., Zeig S., and Spiegel D.M. Cinacalcet HCl controls secondary hyperparathyroidism (HPT) in dialysis patients regardless of disease severity J Am Soc Nephrol 14 2003 463A
55. St. Louis, Mo. Abstract F-P0986. Available at: Reed J., Keightley G., and Blumenthal S. The CONTROL STUDY: Enhanced achievement of NKF-K/DOQITM bone metabolism and disease targets using cinacalcet HCl (Sensipar) Accessed March 25, 2005 Presented at: American Society of Nephrology Renal Week October 29-November 1 2004
56. St. Louis, Mo. Abstract PUB479. Available at: Chertow G.M., Corpler C., and Zeig S. Preliminary results from TARGET: Treatment strategies to achieve recom mended K/DOQITM goals in ESRD patients on cinacalcet Accessed March 25, 2005 Presented at: American Society of Nephrology Renal Week October 29-November 1 2004
57. (Suppl) Quarles L.I.D., Spiegel D.M., and Curzi M. The effects of one-year treatment with the calcimimetic AMG 073 on bone health in ESRD patients with secondary hyperparathyroidism (SHPT) Abstract SU-PO510 J Am Soc Nephrol 13 2002 572A
58. Lisbon, Portugal. Abstract M016. Available at: Malluche H.H., Monier-Faugere M.C., and Wang G. Cinacalcet HCl reduces bone turnover and bone mar row fibrosis in hemodialysis patients with secondary hyperparathyroidism (HPT) Accessed April 24, 2005 Presented at: 41st Congress of the European Renal Association and the European Dialysis and Transplant Association May 15-18 2004
59. St. Louis, Mo. Abstract F-P0997. Available at: Amerling R., Modugno M., and Goretsky S. Effects of cinacalcet on 1-84 PTH and 7-84 PTH Accessed March 28, 2005 Presented at: American Society of Nephrology Renal Week October 29-November 1 2004
60. Lien Y.H., Silva A.L., and Whittman D. Effects of cinacalcet on bone mineral density in patients with secondary hyperparathyroidism Nephrol Dial Transplant 20 2005 1232 1237
61. Abstract SA 420 Silverberg S.J., Faiman C., and Bilezikian J.P. The effects of cinacalcet HCl (AMG 073) on serum calcium levels in patients with parathyroid carcinoma or recurrent primary HPT after PTX J Bone Miner Res 18 Suppl 2 2003 5171
62. Abstract SA 495 Silverberg S.J., Faiman C., and Bilezikian J.P. Cinacalcet HCl effectively treats hypercalcemia in patients with parathyroid carcinoma J Bone Miner Res 19 Suppl 1 2004 S103
63. Abstract M410 Rubin M., Sliney J., and McCary L.C. Effective management of severe hypercalcemia with the calcimimetic cinacalcet HCl in patients with parathyroid carcinoma J Bone Miner Res 18 Suppl 1 2003 S392
64. Collins M.T., Skarulis M.C., and Bilezikian J.P. Treatment of hypercalcemia secondary to parathyroid carcinoma with a novel calcimimetic agent J Clin Endocrinol Metab 83 1998 1083 1088
65. Abstract SA-P0744 Padhi D., Harris R., and Salfi M. Cinacalcet HCl absorption in study subjects is not affected by coadministration of medications commonly prescribed to chronic kidney disease (CKD) patients (pantoprazole, sevelamer HCl, and calcium carbonate) J Am Soc Nephrol 14 2003 461A
66. Yokoyama K., Shigematsu T., and Tsukada T. Calcium-sensing receptor gene polymorphism affects the parathyroid response to moderate hypercalcemic suppression in patients with end-stage renal disease Clin Nephrol 57 2002 131 135
67. Rothe H.M., Shapiro W.B., Sun W.Y., and Chou S.Y. Calcium-sensing receptor gene polymorphism Arg990G1y and its possible effect on response to cinacalcet HCl PharmacogenetGenomics 15 2005 29 34
68. Cunningham J., Danese M., and Olson K. Effects of the calcimimetic cinacalcet HCl on cardiovascular disease, fracture and health related quality of life in secondary hyperparathyroidism Kidney Int 68 2005 1793 1800
69. Cunningham J. Achieving therapeutic targets in the treatment of secondary hyperparathyroidism Nephrol Dial Transplant 19 Suppl 5 2004 V9 V14