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Etelcalcetide

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https://www.readbyqxmd.com/read/29719376/theoretical-overview-of-clinical-and-pharmacological-aspects-of-the-use-of-etelcalcetide-in-diabetic-patients-undergoing-hemodialysis
#1
REVIEW
Jianzhen Ye, Guangrui Deng, Feng Gao
Etelcalcetide is the first intravenous calcimimetic agent authorized for the treatment of secondary hyperparathyroidism (sHPT) in patients undergoing hemodialysis in Europe, the US, and Japan. The relationship between sHPT and diabetes resides on complex, bidirectional effects and largely unknown homeostatic mechanisms. Although 30% or more patients with end-stage renal disease are diabetics and about the same percentage of those patients suffer from sHPT associated with hemodialysis, no data on the specificities of the use of etelcalcetide in such patients are available yet...
2018: Drug Design, Development and Therapy
https://www.readbyqxmd.com/read/29691773/etelcalcetide-for-treating-secondary-hyperparathyroidism-an-evidence-review-group-evaluation-of-a-nice-single-technology-appraisal
#2
Micah Rose, Jonathan Shepherd, Petra Harris, Karen Pickett, Joanne Lord
The manufacturer of the calcimimetic drug etelcalcetide was invited to make an evidence submission as part of the National Institute for Health and Care Excellence (NICE) Single Technology Appraisal (STA) programme. Within this submission, they reported evidence on the clinical and cost effectiveness of etelcalcetide for the treatment of secondary hyperparathyroidism (SHPT) in patients with chronic kidney disease (CKD) on haemodialysis. The Southampton Health Technology Assessments Centre (SHTAC), part of the Wessex Institute at the University of Southampton, was the independent Evidence Review Group (ERG) commissioned to appraise the company's submission...
April 25, 2018: PharmacoEconomics
https://www.readbyqxmd.com/read/29680147/discovery-and-development-of-calcimimetic-and-calcilytic-compounds
#3
Edward F Nemeth, Bradford C Van Wagenen, Manuel F Balandrin
The extracellular calcium receptor (CaR) is a G protein-coupled receptor (GPCR) and the pivotal molecule regulating systemic Ca2+ homeostasis. The CaR was a challenging target for drug discovery because its physiological ligand is an inorganic ion (Ca2+ ) rather than a molecule so there was no structural template to guide medicinal chemistry. Nonetheless, small molecules targeting this receptor were discovered. Calcimimetics are agonists or positive allosteric modulators of the CaR, while calcilytics are antagonists and all to date are negative allosteric modulators...
2018: Progress in Medicinal Chemistry
https://www.readbyqxmd.com/read/29534286/clinical-pharmacokinetics-and-pharmacodynamics-of-etelcalcetide-a-novel-calcimimetic-for-treatment-of-secondary-hyperparathyroidism-in-patients-with-chronic-kidney-disease-on-hemodialysis
#4
REVIEW
Benjamin Wu, Murad Melhem, Raju Subramanian, Ping Chen, Bethlyn Jaramilla Sloey, Bruno Fouqueray, M Benjamin Hock, Gary L Skiles, Andrew T Chow, Edward Lee
Etelcalcetide, a d-amino acid peptide, is an intravenous calcimimetic approved for the treatment of secondary hyperparathyroidism. Etelcalcetide binds the calcium-sensing receptor and increases its sensitivity to extracellular calcium, thereby decreasing secretion of parathyroid hormone (PTH) by chief cells. Etelcalcetide and its low-molecular-weight transformation products are rapidly cleared by renal excretion in healthy subjects, but clearance is substantially reduced and dependent on hemodialysis in end-stage renal disease...
March 13, 2018: Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/29440923/managing-hyperparathyroidism-in-hemodialysis-role-of-etelcalcetide
#5
REVIEW
Keith E Eidman, James B Wetmore
Secondary hyperparathyroidism (SHPT) is common in patients receiving maintenance hemodialysis and is associated with adverse outcomes. Currently, SHPT is managed by reducing circulating levels of phosphate with oral binders and parathyroid hormone (PTH) with vitamin D analogs and/or the calcimimetic cinacalcet. Etelcalcetide, a novel calcimimetic administered intravenously (IV) at the end of a hemodialysis treatment session, effectively reduces PTH in clinical trials when given thrice weekly. Additional clinical effects include reductions in circulating levels of phosphate and FGF-23 and an improved profile of markers of bone turnover...
2018: International Journal of Nephrology and Renovascular Disease
https://www.readbyqxmd.com/read/29423207/old-and-new-calcimimetics-for-treatment-of-secondary-hyperparathyroidism-impact-on-biochemical-and-relevant-clinical-outcomes
#6
Luciano Pereira, Catarina Meng, Daniela Marques, João M Frazão
Secondary hyperparathyroidism (SHPT) is associated with increased bone turnover, risk of fractures, vascular calcifications, and cardiovascular and all-cause mortality. The classical treatment for SHPT includes active vitamin D compounds and phosphate binders. However, achieving the optimal laboratory targets is often difficult because vitamin D sterols suppress parathyroid hormone (PTH) secretion, while also promoting calcium and phosphate intestinal absorption. Calcimimetics increase the sensitivity of the calcium-sensing receptor, so that even with lower levels of extracellular calcium a signal can still exist, leading to a decrease of the set-point for systemic calcium homeostasis...
February 2018: Clinical Kidney Journal
https://www.readbyqxmd.com/read/29392552/a-decision-analytic-model-to-assess-the-cost-effectiveness-of-etelcalcetide-vs-cinacalcet
#7
Björn Stollenwerk, Sergio Iannazzo, Ron Akehurst, Michael Adena, Andrew Briggs, Bastian Dehmel, Patrick Parfrey, Vasily Belozeroff
INTRODUCTION: Etelcalcetide is a novel intravenous calcimimetic for the treatment of secondary hyperparathyroidism (SHPT) in haemodialysis patients. The clinical efficacy and safety of etelcalcetide (in addition to phosphate binders and vitamin D and/or analogues [PB/VD]) was evaluated in three phase III studies, including two placebo-controlled trials and a head-to-head study versus the oral calcimimetic cinacalcet. OBJECTIVE: The objective of this study was to develop a decision-analytic model for economic evaluation of etelcalcetide compared with cinacalcet...
May 2018: PharmacoEconomics
https://www.readbyqxmd.com/read/29276237/formulary-drug-review-etelcalcetide
#8
REVIEW
Danial E Baker
Each month, subscribers to The Formulary Monograph Service receive 5 to 6 well-documented monographs on drugs that are newly released or are in late phase 3 trials. The monographs are targeted to Pharmacy & Therapeutics Committees. Subscribers also receive monthly 1-page summary monographs on agents that are useful for agendas and pharmacy/nursing in-services. A comprehensive target drug utilization evaluation/medication use evaluation (DUE/MUE) is also provided each month. With a subscription, the monographs are available online to subscribers...
November 2017: Hospital Pharmacy
https://www.readbyqxmd.com/read/29238762/etelcalcetide-injectable-calcimimetic-for-the-treatment-of-secondary-hyperparathyroidism-in-hemodialysis-dependent-patients
#9
COMPARATIVE STUDY
P A Ureña Torres, J Bover, M Cohen-Solal
Chronic kidney disease is associated with mineral and bone disorders that are now considered as a syndrome. One of the major complications of this syndrome is secondary hyperparathyroidism (SHPT). SHPT increases bone turnover and the risk of fracture. SHPT is also associated with cardiovascular calcification and high mortality risk. The classical medical therapies of SHPT lack long-term efficacy and have undesirable effects on serum calcium and phosphate levels. Surgical parathyroidectomy is a radical therapeutic solution potentially exposing patients to a permanent state of hypoparathyroidism among other complications...
September 2017: Drugs of Today
https://www.readbyqxmd.com/read/29142982/a-single-and-multiple-dose-multicenter-study-of-etelcalcetide-in-japanese-hemodialysis-patients-with-secondary-hyperparathyroidism
#10
Keitaro Yokoyama, Masafumi Fukagawa, Takashi Shigematsu, Takashi Akiba, Akifumi Fujii, Akinori Yamauchi, Motoi Odani, Tadao Akizawa
Introduction: The pharmacokinetics, pharmacodynamics, and safety and tolerability profile of etelcalcetide (ONO-5163/AMG 416), a novel, i.v., long-acting calcium-sensing receptor agonist, were studied in Japanese hemodialysis patients with secondary hyperparathyroidism. Methods: This multicenter, randomized, double-blind, placebo-controlled, parallel-group study consisted of a single dose part and a multiple dose (3 times weekly for 4 weeks) part. Major inclusion criteria were hemodialysis for at least 90 days, serum intact parathyroid hormone (iPTH) ≥ 300 pg/ml, and serum albumin-corrected Ca (cCa) ≥ 9...
July 2017: KI Reports
https://www.readbyqxmd.com/read/29038882/etelcalcetide-a-novel-calcimimetic-prevents-vascular-calcification-in-a-rat-model-of-renal-insufficiency-with-secondary-hyperparathyroidism
#11
Longchuan Yu, James E Tomlinson, Shawn T Alexander, Kelly Hensley, Chun-Ya Han, Denise Dwyer, Marina Stolina, Charles Dean, William G Goodman, William G Richards, Xiaodong Li
Etelcalcetide, a novel peptide agonist of the calcium-sensing receptor, prevents vascular calcification in a rat model of renal insufficiency with secondary hyperparathyroidism. Vascular calcification occurs frequently in patients with chronic kidney disease (CKD) and is a consequence of impaired mineral homeostasis and secondary hyperparathyroidism (SHPT). Etelcalcetide substantially lowers parathyroid hormone (PTH) and fibroblast growth factor-23 (FGF23) levels in SHPT patients on hemodialysis. This study compared the effects of etelcalcetide and paricalcitol on vascular calcification in rats with adenine-induced CKD and SHPT...
December 2017: Calcified Tissue International
https://www.readbyqxmd.com/read/28867373/etelcalcetide-amg-416-a-peptide-agonist-of-the-calcium-sensing-receptor-preserved-cortical-bone-structure-and-bone-strength-in-subtotal-nephrectomized-rats-with-established-secondary-hyperparathyroidism
#12
Xiaodong Li, Longchuan Yu, Frank Asuncion, Mario Grisanti, Shawn Alexander, Kelly Hensley, Chun-Ya Han, Qing-Tian Niu, Denise Dwyer, Kelly Villasenor, Marina Stolina, Charles Dean, Michael S Ominsky, Hua Zhu Ke, James E Tomlinson, William G Richards
Sustained elevation of parathyroid hormone (PTH) is catabolic to cortical bone, as evidenced by deterioration in bone structure (cortical porosity), and is a major factor for increased fracture risk in chronic kidney disease (CKD). Etelcalcetide (AMG 416), a novel peptide agonist of the calcium-sensing receptor, reduces PTH levels in subtotal nephrectomized (Nx) rats and in hemodialysis patients with secondary hyperparathyroidism (SHPT) in clinical studies; however, effects of etelcalcetide on bone have not been determined...
September 1, 2017: Bone
https://www.readbyqxmd.com/read/28836058/long-term-effects-of-etelcalcetide-as-intravenous-calcimimetic-therapy-in-hemodialysis-patients-with-secondary-hyperparathyroidism
#13
Takashi Shigematsu, Masafumi Fukagawa, Keitaro Yokoyama, Takashi Akiba, Akifumi Fujii, Motoi Odani, Tadao Akizawa
BACKGROUND: Secondary hyperparathyroidism (SHPT) is a serious major complication in hemodialysis patients with chronic kidney disease. Long-term maintenance of serum phosphate, calcium, and parathyroid hormone (PTH) levels in appropriate ranges in these patients is a major challenge. We investigated the efficacy and safety of long-term treatment with etelcalcetide, a novel intravenous calcimimetic, in Japanese SHPT patients on long-term hemodialysis. METHODS: This study was a multicenter open-label study...
April 2018: Clinical and Experimental Nephrology
https://www.readbyqxmd.com/read/28804155/insulin-degludec-liraglutide
#14
REVIEW
Danial E Baker
Each month, subscribers to The Formulary Monograph Service receive 5 to 6 well-documented monographs on drugs that are newly released or are in late phase 3 trials. The monographs are targeted to Pharmacy & Therapeutics Committees. Subscribers also receive monthly 1-page summary monographs on agents that are useful for agendas and pharmacy/nursing in-services. A comprehensive target drug utilization evaluation/medication use evaluation (DUE/MUE) is also provided each month. With a subscription, the monographs are available online to subscribers...
May 2017: Hospital Pharmacy
https://www.readbyqxmd.com/read/28803497/exploring-the-potential-value-of-improved-care-for-secondary-hyperparathyroidism-with-a-novel-calcimimetic-therapy
#15
Björn Stollenwerk, Sergio Iannazzo, Kerry Cooper, Vasily Belozeroff
AIMS: This study explored the use of a value-based pricing approach for the new calcimimetic etelcalcetide indicated for the treatment of secondary hyperparathyroidism (SHPT) in patients receiving hemodialysis. It used the US payer perspective and applied the cost-effectiveness framework. Because etelcalcetide is an intravenous therapy that can be titrated for individual patients, and because its utilization is yet to be assessed in real world settings, a range of plausible doses were estimated for etelcalcetide to define a range of prices...
August 14, 2017: Journal of Medical Economics
https://www.readbyqxmd.com/read/28794306/the-pharmacological-profile-and-the-clinical-efficacy-of-the-world-s-1st-intravenous-calcimimetics-etelcalcetide-hydrochloride-parsabiv-%C3%A2
#16
Kazutsune Harada, Atsuto Inoue, Akinori Yamauchi, Akifumi Fujii
No abstract text is available yet for this article.
2017: Nihon Yakurigaku Zasshi. Folia Pharmacologica Japonica
https://www.readbyqxmd.com/read/28671062/a-12-week-dose-escalating-study-of-etelcalcetide-ono-5163-amg-416-a-novel-intravenous-calcimimetic-for-secondary-hyperparathyroidism-in-japanese-hemodialysis-patients
#17
MULTICENTER STUDY
Keitaro Yokoyama, Masafumi Fukagawa, Takashi Shigematsu, Takashi Akiba, Akifumi Fujii, Motoi Odani, Tadao Akizawa
AIMS: To evaluate dose-escalation of etelcalcetide (ONO-5163/AMG 416), a novel, intravenous (IV), long-acting calcium-sensing receptor agonist, for treatment of secondary hyperparathyroidism (SHPT) in Japanese hemodialysis patients. MATERIALS AND METHODS: In this multicenter study, IV injections of etelcalcetide (3 times a week for 12 weeks) were administered, with dose escalation every 4 weeks depending on changes in serum intact parathyroid hormone (iPTH) and corrected calcium (cCa)...
August 2017: Clinical Nephrology
https://www.readbyqxmd.com/read/28615947/treatment-of-secondary-hyperparathyroidism-the-clinical-utility-of-etelcalcetide
#18
REVIEW
Mario Cozzolino, Andrea Galassi, Ferruccio Conte, Michela Mangano, Luca Di Lullo, Antonio Bellasi
Secondary hyperparathyroidism (SHPT), a very frequent, severe, and worsening complication of chronic kidney disease, is characterized by high serum parathyroid hormone (PTH), parathyroid gland hyperplasia, and disturbances in mineral metabolism. Clinically, SHPT shows renal osteodystrophy, vascular calcification, cardiovascular damage, and fatal outcome. Calcium-sensing receptor (CaSR) is the main physiological regulator of PTH secretion; its activation by calcium rapidly inhibits PTH. Another important player in regulating mineral metabolism is vitamin D receptor (VDR), which is under the influence of vitamin D and influences the intestinal absorption of calcium and phosphate, PTH gene expression, and bone calcium mobilization...
2017: Therapeutics and Clinical Risk Management
https://www.readbyqxmd.com/read/28535231/dosing-of-etelcalcetide-vs-cinacalcet-for-secondary-hyperparathyroidism-reply
#19
LETTER
Geoffrey A Block, Glenn M Chertow
No abstract text is available yet for this article.
May 23, 2017: JAMA: the Journal of the American Medical Association
https://www.readbyqxmd.com/read/28535228/dosing-of-etelcalcetide-and-cinacalcet-for-secondary-hyperparathyroidism
#20
LETTER
Mary T Thanh Hai, Jean-Marc Guettier, Curtis J Rosebraugh
No abstract text is available yet for this article.
May 23, 2017: JAMA: the Journal of the American Medical Association
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