CINACALCET (SENSIPAR) Calcimimetic Agents in CKD | ESRD | Dialysis and Hemodialysis Patients
Patients with chronic kidney disease have special issues in regulating mineral metabolism.
The kidneys actively hold onto necessary minerals and excrete or get rid of minerals thought to be in excessive supply.
Some of these minerals necessary for cellular functions include sodium, potassium, calcium and phosphorous.
The kidneys play a unique role in calcium regulation due to the fact that healthy kidneys activate a form of Vitamin D. Vitamin D in turn facilitates absorption of Calcium from the intestines from the food or from bones.
Other important glands in this metabolic system are the parathyroids. These small glands in the neck secrete a hormone called PTH or parathyroid hormone that boosts the absorption of calcium from the intestine or bones if the body is deemed to have too little calcium.
Patients with abnormal, or scarred kidneys do not make sufficient active Vitamin D. Chronic kidney disease (CKD) patients or end stage renal disease (ESRD) patients
therefore may be deficient in calcium and have an elevated parathyroid level. This elevated PTH level is called secondary hyperparathyrodism.
There are several methods of helping to control mineral metabolism in ESRD and CKD patients. Some of these methods include diet, Vitamin D supplementation and drugs which help absorb excessive minerals from the intestine. A relatively new medication acts to help decrease parathyroid hormone production by making the parathyroid gland more sensitive to calcium. This new class of medication is called a calcimimetic because it mimics the effects of calcium on the parathyroid glands.
The articles reference below discuss calcimemetics in CKD and ESRD.
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David M. Spiegel, Lesley McPhatter, Ann Allison, Joanne C. Drumheller, and Robert Lockridge
CJASN CJN.08170811; published ahead of print February 2012 doi:10.2215/CJN.08170811
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Ikee R, Tsunoda M, Sasaki N, Sato N, Hashimoto N.
Nephrology (Carlton). 2011 Nov 24.
doi: 10.1111/j.1440-1797.2011.01545.x.
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Author Interview: J. Andrew Lee, PhD, ScM
A Study of the Association between Cinacalcet Adherence and Biochemical Outcomes
Abstract: [TH-PO263]
Andrew Lee, PhD, Vasily Belozeroff, PhD, Richard Mutell, T. Christopher Bond, PhD, William G. Goodman, MD. Amgen Inc; DaVita Clinical Research. |
Author Interview: Dr. Jesús Montenegro
Efficacy and safety of cinacalcet for the treatment of secondary hyperparathyroidism in patients with advanced chronic kidney disease before initiation of regular dialysis.
Montenegro J, Cornago I, Gallardo I, García-Ledesma P, Hernando A, Martinez I, Muñoz RI, Romero MA.
Servicio de Nefrología, Hospital de Galdakao-Usansolo, Galdakao, Vizcaya, Spain.
Nephrology (Carlton). 2011 Oct 25. doi: 10.1111/j.1440-1797.2011.01530.x.
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Author Interview: Dr. Giuseppe Cianciolo
VDR Expression on Circulating Endothelial Progenitor Cells in Dialysis Patients Is Modulated by 25(OH)D Serum Levels and Calcitriol Therapy.
Cianciolo G, La Manna G, Cappuccilli ML, Lanci N, Della Bella E, Cuna V, Dormi A, Todeschini P, Donati G, Alviano F, Costa R, Bagnara GP, Stefoni S.
Nephrology Dialysis and Renal Transplantation Unit, S. Orsola University Hospital, Bologna, Italy.
Blood Purif. 2011 Jul 9;32(3):161-173.
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Battistella M, Richardson RM, Bargman JM, Chan CT.
Division of Nephrology, Department of Medicine, University Health Network, Toronto, ON, Canada.
Clin Nephrol. 2011 Aug;76(2):99-103.
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Sensipar(R) Patents Upheld By District Court
Injunction Prohibits Teva and Barr from Marketing Generic Versions of Amgen's Sensipar Through 2018 Patent Expiry
THOUSAND OAKS, Calif., Jan. 7, 2011
A U.S. District Court in Delaware today granted an injunction preventing Teva Pharmaceuticals USA, Inc., Teva Pharmaceuticals Industries Ltd., and Barr Laboratories, Inc. from commercializing generic versions of Amgen's (Nasdaq: AMGN) Sensipar(R) (cinacalcet) until expiration of the drug's U.S. patents. The latest Sensipar expiry is in 2018. Sensipar is approved for the treatment of secondary hyperparathyroidism (HPT) in patients with chronic kidney disease (CKD) on dialysis and for the treatment of elevated levels of calcium in patients with parathyroid carcinoma. |
Nephron Clin Pract. 2010 Aug 10;117(2):c151-c159.
Schumock GT, et al
Center for Pharmacoeconomic Research, Department of Pharmacy Practice, and Department of Pharmacy Administration, University of Illinois at Chicago, Chicago, Ill.
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Calcimimetic Agents in CKD ESRD Dialysis and Hemodialysis Patients
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Sensipar (Cinacalcet) is made by Amgen. The Sensipar website has a number of educational resource, including prescribing and safety information.
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J Nephrology. 2010 May 2. pii: 8E39C3E1-CF8D-4F2A-94D3-D72F4B99DFFC.
Guerra R, Auyanet I, Fernández EJ, Pérez MA, Bosch E, Ramírez A, Suria S, Checa MD.
Department of Nephrology, Hospital Insular de Gran Canaria, Las Palmas de Gran Canaria - Spain. |
Calcimimetic inhibits late-stage cyst growth in ADPKD.
Journal of the American Society of Nephrology. 2009 Jul;20(7):1527-32.
Gattone VH 2nd, Chen NX, Sinders RM, Seifert MF, Duan D, Martin D, Henley C, Moe SM.
Department of Anatomy and Cell Biology, Indiana University School of Medicine, 635 Barnhill Drive, Indianapolis, Indiana 46202, USA. vgattone@iupui.edu
Comment in:
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J Am Soc Nephrol. 2009 Jul;20(7):1421-5.
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