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Etelcalcetide

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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
#1
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
#2
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...
August 23, 2017: Clinical and Experimental Nephrology
https://www.readbyqxmd.com/read/28804155/insulin-degludec-liraglutide
#3
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
#4
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
#5
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-%C3%A2-a-novel-intravenous-calcimimetic-for-secondary-hyperparathyroidism-in-%C3%A2-japanese-hemodialysis-patients%C3%A2
#6
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)...
July 3, 2017: Clinical Nephrology
https://www.readbyqxmd.com/read/28615947/treatment-of-secondary-hyperparathyroidism-the-clinical-utility-of-etelcalcetide
#7
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
#8
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
#9
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
https://www.readbyqxmd.com/read/28508378/population-pharmacokinetic-and-pharmacodynamic-modeling-of-etelcalcetide-in-patients-with-chronic-kidney-disease-and-secondary-hyperparathyroidism-receiving-hemodialysis
#10
Ping Chen, Adimoolam Narayanan, Benjamin Wu, Per Olsson Gisleskog, John P Gibbs, Andrew T Chow, Murad Melhem
INTRODUCTION: Etelcalcetide is a novel calcimimetic that binds and activates calcium-sensing receptors (CaSRs) for the treatment of secondary hyperparathyroidism (SHPT). METHODS: To assess titrated dosing regimens, population pharmacokinetic (PK) and PK/pharmacodynamic (PKPD) modeling of etelcalcetide was performed using NONMEM 7.2. In this analysis, plasma etelcalcetide, serum parathyroid hormone (PTH) and calcium (Ca) concentration-time data were collected from five phase I, II, and III clinical trials following single or multiple intravenous doses of etelcalcetide ranging from 2...
May 15, 2017: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/28381914/pharmaceutical-approval-update
#11
Mary Choy
Abuse-deterrent hydrocodone bitartrate (Vantrela ER) for long-term opioid treatment; etelcalcetide (Parsabiv) for secondary hyperparathyroidism in patients with chronic kidney disease on hemodialysis; and deflazacort (Emflaza) for Duchenne muscular dystrophy.
April 2017: P & T: a Peer-reviewed Journal for Formulary Management
https://www.readbyqxmd.com/read/28336834/-parenteral-calcimimetics-for-the-treatment-of-secondary-hyperparathyroidism
#12
Naoto Hamano, Masafumi Fukagawa
The oral calcimimetics, cinacalcet, is reported to be effective on secondary hyperparathyroidism resistant to classical treatment like phosphate binders or vitamin D receptor activator. The problem that gastrointestinal adverse events cause poor adherence, drug discontinuation, and insufficient dose escalation remains unsolved. The novel injectable calcimimetic, etelcalcetide, is recently developed and is expected to reduce such adverse events and improve the therapeutic effects on moderate to severe secondary hyperparathyroidism...
2017: Clinical Calcium
https://www.readbyqxmd.com/read/28336830/-the-discovery-research-and-development-of-etelcalcetide-hydrochloride-the-world-1st-intravenous-calcimimetics
#13
Atsuto Inoue, Kazutsune Harada
Etelcalcetide hydrochloride is the first intravenous calcimimetics agent for secondary hyperparathyroidism (SHPT). Etelcalcetide hydrochloride is to be administered through dialysis circuit by physician or medical staff upon completion of dialysis and such administration is expected to reduce the burden of medication in patients. From the nonclinical study results, etelcalcetide functions as an allosteric activator of calcium-sensing receptor(CaSR). Etelcalcetide suppressed PTH secretion both in vitro and in vivo...
2017: Clinical Calcium
https://www.readbyqxmd.com/read/28277829/etelcalcetide-for-the-treatment-of-secondary-hyperparathyroidism
#14
REVIEW
Naoto Hamano, Hirotaka Komaba, Masafumi Fukagawa
Calcium sensing receptor is an important target for the treatment of secondary hyperparathyroidism (SHPT). Etelcalcetide hydrochloride is a novel peptide calcimimetic agent that has a similar mechanism of action as cinacalcet hydrochloride. Clinical trials of etelcalcetide have been performed in the US, Europe, and Japan, and these trials demonstrated the safety and efficacy of etelcalcetide in dialysis patients. Etelcalcetide has recently been approved in Europe, the US and Japan. Areas covered: We review the development, pharmacokinetics, and clinical efficacy and safety of etelcalcetide for the treatment of SHPT in hemodialysis patients...
April 2017: Expert Opinion on Pharmacotherapy
https://www.readbyqxmd.com/read/28274835/clinical-immunogenicity-of-the-d-amino-acid-peptide-therapeutic-etelcalcetide-method-development-challenges-and-anti-drug-antibody-clinical-impact-assessments
#15
RANDOMIZED CONTROLLED TRIAL
Mark A Kroenke, Dohan K Weeraratne, Hongjie Deng, Bethlyn Sloey, Raju Subramanian, Benjamin Wu, Michael Serenko, M Benjamin Hock
The immunogenicity risk assessment and bioanalytical strategy for novel therapeutics should account for both unique biophysical properties and potential consequences of immunogenicity. When assessing the immunogenicity risk of etelcalcetide, a peptide agonist of the calcium-sensing receptor, we considered the potential that the d-amino acid 'backbone' and biotransformation of etelcalcetide could allow the drug to act as a hapten. As a consequence, we validated and implemented a surface plasmon resonance immunoassay platform with both etelcalcetide and etelcalcetide-'carrier' surfaces to detect anti-drug antibodies (ADA)...
June 2017: Journal of Immunological Methods
https://www.readbyqxmd.com/read/28097356/effect-of-etelcalcetide-vs-cinacalcet-on-serum-parathyroid-hormone-in-patients-receiving-hemodialysis-with-secondary-hyperparathyroidism-a-randomized-clinical-trial
#16
RANDOMIZED CONTROLLED TRIAL
Geoffrey A Block, David A Bushinsky, Sunfa Cheng, John Cunningham, Bastian Dehmel, Tilman B Drueke, Markus Ketteler, Reshma Kewalramani, Kevin J Martin, Sharon M Moe, Uptal D Patel, Justin Silver, Yan Sun, Hao Wang, Glenn M Chertow
Importance: Secondary hyperparathyroidism contributes to extraskeletal calcification and is associated with all-cause and cardiovascular mortality. Control is suboptimal in the majority of patients receiving hemodialysis. An intravenously (IV) administered calcimimetic could improve adherence and reduce adverse gastrointestinal effects. Objective: To evaluate the relative efficacy and safety of the IV calcimimetic etelcalcetide and the oral calcimimetic cinacalcet...
January 10, 2017: JAMA: the Journal of the American Medical Association
https://www.readbyqxmd.com/read/28097355/effect-of-etelcalcetide-vs-placebo-on-serum-parathyroid-hormone-in-patients-receiving-hemodialysis-with-secondary-hyperparathyroidism-two-randomized-clinical-trials
#17
RANDOMIZED CONTROLLED TRIAL
Geoffrey A Block, David A Bushinsky, John Cunningham, Tilman B Drueke, Markus Ketteler, Reshma Kewalramani, Kevin J Martin, T Christian Mix, Sharon M Moe, Uptal D Patel, Justin Silver, David M Spiegel, Lulu Sterling, Liron Walsh, Glenn M Chertow
Importance: Secondary hyperparathyroidism contributes to extraskeletal complications in chronic kidney disease. Objective: To evaluate the effect of the intravenous calcimimetic etelcalcetide on serum parathyroid hormone (PTH) concentrations in patients receiving hemodialysis. Design, Setting, and Participants: Two parallel, phase 3, randomized, placebo-controlled treatment trials were conducted in 1023 patients receiving hemodialysis with moderate to severe secondary hyperparathyroidism...
January 10, 2017: JAMA: the Journal of the American Medical Association
https://www.readbyqxmd.com/read/28063122/drug-disposition-model-of-radiolabeled-etelcalcetide-in-patients-with-chronic-kidney-disease-and-secondary-hyperparathyroidism-on-hemodialysis
#18
Liviawati Wu, Murad Melhem, Raju Subramanian, Benjamin Wu
Etelcalcetide (AMG 416) is an allosteric activator of the calcium-sensing receptor for treatment of secondary hyperparathyroidism in patients with chronic kidney disease (CKD) on hemodialysis. To characterize the time course of etelcalcetide in different matrices (plasma, dialysate, urine, and feces), a drug disposition model was developed. Nonlinear mixed-effect modeling was used to describe data from six adults with CKD on hemodialysis who received a single intravenous dose of [(14)C]etelcalcetide (10 mg; 710 nCi) after hemodialysis (study NCT02054572)...
February 2017: Journal of Pharmacokinetics and Pharmacodynamics
https://www.readbyqxmd.com/read/28057872/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
#19
Masafumi Fukagawa, Keitaro Yokoyama, Takashi Shigematsu, Takashi Akiba, Akifumi Fujii, Takuto Kuramoto, Motoi Odani, Tadao Akizawa
BACKGROUND: Secondary hyperparathyroidism (SHPT) is a major complication associated with chronic kidney disease. We evaluated the efficacy and safety of etelcalcetide (ONO-5163/AMG 416), a novel intravenous calcimimetic, in Japanese haemodialysis patients with SHPT. METHODS: In this phase 3, multicentre, randomized, double-blind, placebo-controlled, parallel-group study, etelcalcetide was administered three times per week at an initial dose of 5 mg, and subsequently adjusted to doses between 2...
January 5, 2017: Nephrology, Dialysis, Transplantation
https://www.readbyqxmd.com/read/27971361/assessing-the-cost-utility-of-etelcalcetide-a-markov-model
#20
B Stollenwerk, S Iannazzo, R Akehurst, M Adena, A Briggs, B Dehmel, P Parfrey, V Belozeroff
No abstract text is available yet for this article.
November 2016: Value in Health: the Journal of the International Society for Pharmacoeconomics and Outcomes Research
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