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https://www.readbyqxmd.com/read/27900648/etelcalcetide-first-global-approval
#1
Hannah A Blair
Etelcalcetide (Parsabiv™) is a novel second generation calcimimetic agent developed by Amgen for the treatment of secondary hyperparathyroidism (SHPT), a complication of chronic kidney disease (CKD). Etelcalcetide reduces circulating levels of parathyroid hormone and calcium by binding directly to the calcium-sensing receptor. Intravenous etelcalcetide has been approved in the EU for the treatment of SHPT in adult patients with CKD on haemodialysis therapy. Regulatory applications for etelcalcetide in SHPT are also under review in the USA and Japan...
November 29, 2016: Drugs
https://www.readbyqxmd.com/read/27899108/geographic-variation-of-parathyroidectomy-in-patients-receiving-hemodialysis-a-retrospective-cohort-analysis
#2
James B Wetmore, Jiannong Liu, Paul J Dluzniewski, Areef Ishani, Geoffrey A Block, Allan J Collins
BACKGROUND: Secondary hyperparathyroidism (SHPT) is associated with adverse outcomes in patients receiving maintenance dialysis. Parathyroidectomy is a treatment for SHPT; whether parathyroidectomy utilization varies geographically in the US is unknown. METHODS: A retrospective cohort analysis was undertaken to identify all patients aged 18 years or older who were receiving in-center hemodialysis between 2007 and 2009, were covered by Medicare Parts A and B, and had been receiving hemodialysis for at least 1 year...
November 29, 2016: BMC Surgery
https://www.readbyqxmd.com/read/27880946/2md-dp001-a-single-agent-in-the-management-of-hemodialysis-patients-a-randomized-trial
#3
Ravi Thadhani, Julia B Zella, Danielle C Knutson, William J Blaser, Lori A Plum, Margaret Clagett-Dame, Raymond D Buck, Hector F DeLuca
BACKGROUND: Vitamin D analogs and calcimimetics are used to manage secondary hyperparathyroidism (SHPT) in dialysis patients. DP001 is an oral vitamin D analog that suppresses parathyroid hormone (PTH) in uremic rats, osteopenic women, and hemodialysis patients. The safety and effectiveness of DP001 suppressing PTH in dialysis patients previously managed with active vitamin D with or without a calcimimetic are presented. METHODS: A multicenter, randomized, double-blind study compared DP001 to placebo in hemodialysis patients with serum-intact PTH (iPTH) ≥300 pg/ml...
November 24, 2016: American Journal of Nephrology
https://www.readbyqxmd.com/read/27876426/pin1-and-secondary-hyperparathyroidism-of-chronic-kidney-disease-gene-polymorphisms-and-protein-levels
#4
Yu Zhao, Li-Li Zhang, Fa-Xian Ding, Ping Cao, Yuan-Yuan Qi, Jing Wang
BACKGROUND: Peptidyl-prolyl cis/trans isomerase NIMA-interacting 1 (Pin1) is a key regulator of PTH mRNA stability. Secondary hyperparathyroidism (SHPT), which is characterized by elevated serum PTH levels, is a common complication of CKD. We investigated the possible associations between CKD with SHPT (CKD SHPT) and single-nucleotide polymorphisms of the Pin1 gene and compared the levels of the Pin1 protein in the CKD SHPT patients with those of the controls. METHODS: The study group included 251 CKD SHPT patients and 61 controls...
November 23, 2016: Renal Failure
https://www.readbyqxmd.com/read/27846800/treatment-with-cinacalcet-increases-plasma-sclerostin-concentration-in-hemodialysis-patients-with-secondary-hyperparathyroidism
#5
Piotr Kuczera, Marcin Adamczak, Andrzej Więcek
BACKGROUND: Sclerostin is a paracrine acting factor, which is expressed in the osteocytes and articular chondrocytes. Sclerostin decreases the osteoblast-related bone formation through the inhibition of the Wnt/β-catenin pathway. Osteocytes also express the Calcium sensing receptor which is a target for cinacalcet. The aim of this study was to assess the influence of six-month cinacalcet treatment on plasma sclerostin concentration in hemodialysed patients with secondary hyperparathyroidism (sHPT)...
November 15, 2016: BMC Nephrology
https://www.readbyqxmd.com/read/27846313/clinical-and-genetic-analysis-of-multiple-endocrine-neoplasia-type-1-related-primary-hyperparathyroidism-in-chinese
#6
Jing Kong, Ou Wang, Min Nie, Jie Shi, Yingying Hu, Yan Jiang, Mei Li, Weibo Xia, Xunwu Meng, Xiaoping Xing
OBJECTIVE: Multiple endocrine neoplasia type 1-related primary hyperparathyroidism (MHPT) differs in many aspects from sporadic PHPT (SHPT). The aims of this study were to summarize the clinical features and genetic background of Chinese MHPT patients and compare the severity of the disease with those of SHPT. DESIGN AND METHODS: A total of 40 MHPT (27 sporadic, 7 families) and 169 SHPT cases of Chinese descent were retrospectively analyzed. X-rays and ultrasound were used to assess the bone and urinary system...
2016: PloS One
https://www.readbyqxmd.com/read/27845598/efficacy-of-microwave-ablation-for-severe-secondary-hyperparathyroidism-in-subjects-undergoing-hemodialysis
#7
Zongli Diao, Liyan Wang, Dishan Li, Wenhu Liu
Severe secondary hyperparathyroidism (SHPT) is a serious problem in patients undergoing hemodialysis. The efficacy and safety of microwave ablation (MWA), a minimally invasive treatment, for severe SHPT are as yet unclear. To clarify the role of MWA, we administered it to patients with severe SHPT and assessed its efficacy and safety. This was a prospective, single-center, single-arm, clinical trial. We enrolled patients with severe SHPT attending our hemodialysis center who met the inclusion and exclusion criteria...
November 15, 2016: Renal Failure
https://www.readbyqxmd.com/read/27827962/cholecalciferol-additively-reduces-serum-parathyroid-hormone-and-increases-vitamin-d-and-cathelicidin-levels-in-paricalcitol-treated-secondary-hyperparathyroid-hemodialysis-patients
#8
Jing-Quan Zheng, Yi-Chou Hou, Cai-Mei Zheng, Chien-Lin Lu, Wen-Chih Liu, Chia-Chao Wu, Ming-Te Huang, Yuh-Feng Lin, Kuo-Cheng Lu
BACKGROUND: Active Vitamin D analogues are used clinically for prevention and treatment of secondary hyperparathyroidism (SHPT) in hemodialysis (HD) patients. Nutritional vitamin D supplementation is used for additional local parathyroid (PTH) suppression, with lower incidence of hypercalcemia and hyperphosphatemia. This study evaluates the possible beneficial effects of combined vitamin D treatment (paricalcitol and cholecalciferol). METHODS: Sixty HD patients with serum parathyroid hormone (iPTH) >300 pg/mL were enrolled...
November 5, 2016: Nutrients
https://www.readbyqxmd.com/read/27822674/conversion-of-oral-alfacalcidol-to-oral-calcitriol-in-the-treatment-of-secondary-hyperparathyroidism-in-chronic-hemodialysis-patients
#9
Sandrine Rauscher, Jean-Philippe Lafrance, Vincent Pichette, Robert Z Bell, Katherine Desforges, Laurence Lepage, Georges Ouellet, Denis Ouimet, Martine Leblanc, Caroline Lamarche, Sarah Bezzaoucha, Michel Vallee
PURPOSE: The optimal vitamin D3 therapy for the treatment of secondary hyperparathyroidism (SHPT) in chronic hemodialysis patients is still controversial. Recent studies suggest that uremia in end-stage renal disease is associated with enzymatic hepatic dysfunction altering 25-hydroxylation of vitamin D3. The goal of our study was to compare the efficacy of calcitriol, the fully hydroxylated active form of vitamin D3, to alfacalcidol which needs 25-hydroxylation to be effective, for the treatment of SHPT in chronic hemodialysis patients...
November 8, 2016: International Urology and Nephrology
https://www.readbyqxmd.com/read/27757708/feasibility-of-photodynamic-therapy-for-secondary-hyperparathyroidism-in-chronic-renal-failure-rats
#10
Takayo Miyakogawa, Genta Kanai, Ryoko Tatsumi, Hiroo Takahashi, Kaichiro Sawada, Takatoshi Kakuta, Masafumi Fukagawa
BACKGROUND: Feasibility of photodynamic therapy (PDT) for secondary hyperparathyroidism (SHPT) was examined in a rat model of SHPT. METHODS: A photosensitizer, 5-aminolevulinic acid (5-ALA), was injected intraperitoneally, and the parathyroid glands were irradiated either after surgical exposure with 385-nm light or transdermally with 630-nm light from a light-emitting diode (LED) lamp. RESULTS: PDT with high 5-ALA and irradiation doses caused severe hypoparathyroidism in SHPT rats within two days...
October 18, 2016: Clinical and Experimental Nephrology
https://www.readbyqxmd.com/read/27741007/total-parathyroidectomy-with-routine-thymectomy-and-autotransplantation-versus-total-parathyroidectomy-alone-for-secondary-hyperparathyroidism-results-of-a-nonconfirmatory-multicenter-prospective-randomized-controlled-pilot-trial
#11
Katja Schlosser, Detlef K Bartsch, Markus K Diener, Christoph M Seiler, Tom Bruckner, Christoph Nies, Moritz Meyer, Jens Neudecker, Peter E Goretzki, Gabriel Glockzin, Ralf Konopke, Matthias Rothmund
OBJECTIVE: This randomized controlled multicenter pilot trial was conducted to find robust estimates for the rates of recurrence of 2 surgical strategies for secondary hyperparathyroidism (SHPT) within 36 months of follow-up. BACKGROUND: SHPT is a frequent consequence of chronic renal failure. Total parathyroidectomy with autotransplantation (TPTX+AT) and subtotal parathyroidectomy (SPTX) are the standard surgical procedures. Total parathyroidectomy alone (TPTX) might be a good alternative, as morbidity and recurrence rates are low according to small-scale retrospective studies...
November 2016: Annals of Surgery
https://www.readbyqxmd.com/read/27739473/associations-of-the-calcium-sensing-receptor-gene-casr-rs7652589-snp-with-nephrolithiasis-and-secondary-hyperparathyroidism-in-haemodialysis-patients
#12
Alicja E Grzegorzewska, Mateusz Paciorkowski, Adrianna Mostowska, Bartosz Frycz, Wojciech Warchoł, Ireneusz Stolarek, Marek Figlerowicz, Paweł P Jagodziński
Nephrolithiasis, secondary hyperparathyroidism (sHPT), and cardiovascular complications are associated with disturbances in Ca handling and contribute to morbidity/mortality during haemodialysis (HD). Calcimimetics, activators of the calcium-sensing receptor (CaSR), provide an effective means of reducing parathyroid hormone (PTH) secretion in sHPT. Polymorphism in CaSR gene (CASR) influences Ca-related parameters, however it was not shown in HD patients for CASR rs7652589. The minor allele at this polymorphism modifies the binding sites of transcription factors and CaSR expression...
October 14, 2016: Scientific Reports
https://www.readbyqxmd.com/read/27738907/secondary-hyperparathyroidism-prevalence-and-prognostic-role-in-elderly-males-with-heart-failure
#13
G Loncar, B Bozic, N Cvetinovic, H-D Dungen, M Lainscak, S von Haehling, W Doehner, Z Radojicic, B Putnikovic, T Trippel, V Popovic
AIM: Evaluation of secondary hyperparathyroidism (SHPT) and its prognostic impact on all-cause mortality in elderly males with heart failure (HF). METHODS: Seventy three males (67 ± 7 years old) with systolic HF were included. Baseline PTH was measured. Patients were grouped according to PTH cut-off levels of 65 pg/ml (>65 pg/ml = SHPT vs. normal PTH). All-cause mortality was evaluated at 6-year follow-up. RESULTS: SHPT was diagnosed in 43 (59 %) patients...
October 13, 2016: Journal of Endocrinological Investigation
https://www.readbyqxmd.com/read/27737390/factors-associated-with-subendocardial-ischemia-risk-in-patients-on-hemodialysis
#14
Bruno Caldin da Silva, Adriano Sanjuan, Valéria Costa-Hong, Luciene Dos Reis, Fabiana Graciolli, Fernanda Consolim-Colombo, Luiz Aparecido Bortolotto, Rosa Maria Affonso Moyses, Rosilene Motta Elias
Introduction: Bone metabolism disorder (BMD) and vascular dysfunction contribute to excess cardiovascular mortality observed in hemodialysis patients. Vascular dysfunction, a new marker of atherosclerosis, can play a role in this risk. Even though associated with higher mortality in the general population, such vascular evaluation in patients on hemodialysis has not been extensively studied. Methods: In this cross-sectional study, hemodialysis patients were submitted to flow-mediated dilation, subendocardial viability ratio (SEVR) and ejection duration index assessment, in order to estimate the impact of BMD markers on vascular dysfunction...
July 2016: Jornal Brasileiro de Nefrologia: ʹorgão Oficial de Sociedades Brasileira e Latino-Americana de Nefrologia
https://www.readbyqxmd.com/read/27737389/cost-effectiveness-analysis-of-paricalcitol-versus-calcitriol-for-the-treatment-of-shpt-in-dialytic-patients-from-the-sus-perspective
#15
Fabiana Gatti de Menezes, Rodrigo Martins Abreu, Alexander Itria
Introduction: Secondary hyperparathyroidism (SHPT) is a consequence of chronic kidney disease. The treatment at the Brazilian Unified Heath System (SUS) is performed with calcitriol, a drug which favors hypercalcemia and/or hyperphosphatemia, hindering the control of SHPT. Another option is paricalcitol, which causes parathormone (PTH) suppression faster than calcitriol, with minor changes in calcium-phosphorus product and calcium and phosphorus serum levels. Objective: This study aims to develop a cost-effectiveness analysis of paricalcitol versus calcitriol for patients in dialytic treatment with SHPT, from the SUS perspective...
July 2016: Jornal Brasileiro de Nefrologia: ʹorgão Oficial de Sociedades Brasileira e Latino-Americana de Nefrologia
https://www.readbyqxmd.com/read/27737388/effectiveness-and-safety-of-a-6-month-treatment-with-paricalcitol-in-patients-on-hemodialysis-with-secondary-hyperparathyroidism
#16
Inés Olaizola, Hena Caorsi, Laura Fajardo, Alejandro Ferreiro, Nieves Campistrus, Deyanira Dolinsky, Alicia Petraglia, Pablo Ambrosoni
Introduction: The mineral bone disorder, particularly secondary hyperparathyroidism, in chronic kidney disease (CKD) has a systemic impact affecting not only bone metabolism. Therefore its correction is important to prevent cardiovascular, inflammatory and immune diseases. Objective: To assess the effectiveness and safety of intravenous paricalcitol administered over a 6 month period for the treatment of secondary hyperparathyroidism (SHPT) in patients undergoing conventional hemodialysis, with close follow-up of treatment response...
July 2016: Jornal Brasileiro de Nefrologia: ʹorgão Oficial de Sociedades Brasileira e Latino-Americana de Nefrologia
https://www.readbyqxmd.com/read/27676085/use-of-extended-release-calcifediol-to-treat-secondary-hyperparathyroidism-in-stages-3-and-4-chronic-kidney-disease
#17
Stuart M Sprague, Paul W Crawford, Joel Z Melnick, Stephen A Strugnell, Shaukat Ali, Roberto Mangoo-Karim, Sungchun Lee, P Martin Petkovich, Charles W Bishop
BACKGROUND/AIMS: Vitamin D insufficiency and secondary hyperparathyroidism (SHPT) are associated with increased morbidity and mortality in chronic kidney disease (CKD) and are poorly addressed by current treatments. The present clinical studies evaluated extended-release (ER) calcifediol, a novel vitamin D prohormone repletion therapy designed to gradually correct low serum total 25-hydroxyvitamin D, improve SHPT control and minimize the induction of CYP24A1 and FGF23. METHODS: Two identical multicenter, randomized, double-blind, placebo-controlled studies enrolled subjects from 89 US sites...
September 28, 2016: American Journal of Nephrology
https://www.readbyqxmd.com/read/27639083/population-pharmacokinetics-and-pharmacodynamics-of-the-calcimimetic-etelcalcetide-in-chronic-kidney-disease-and-secondary-hyperparathyroidism-receiving-hemodialysis
#18
P Chen, P Olsson Gisleskog, J J Perez-Ruixo, J Xiao, J Wilkins, A Narayanan, J P Gibbs, M Melhem
Etelcalcetide is a novel calcimimetic in development for the treatment of secondary hyperparathyroidism (SHPT). A population pharmacokinetic/pharmacodynamic (PK/PD) model was developed relating etelcalcetide exposures to markers of efficacy (parathyroid hormone [PTH]) and safety (calcium) using data from three clinical studies. The semimechanistic model was developed that included allosteric activation pharmacology and understanding of calcium homeostasis. The temporal profiles for all biomarkers were well described by the model...
September 2016: CPT: Pharmacometrics & Systems Pharmacology
https://www.readbyqxmd.com/read/27598394/parathyroidectomy-increases-heart-rate-variability-and-leptin-levels-in-patients-with-stage-5-chronic-kidney-disease
#19
Yao Jiang, Zhixiang Shen, Jingjing Zhang, Changying Xing, Xiaoming Zha, Chong Shen, Ming Zeng, Guang Yang, Huijuan Mao, Bo Zhang, Xiangbao Yu, Bin Sun, Chun Ouyang, Yifei Ge, Lina Zhang, Chen Cheng, Jing Zhang, Caixia Yin, Huimin Chen, Ningning Wang
BACKGROUND: In chronic kidney disease (CKD) patients, decreased heart rate variability (HRV) reflects impaired cardiac automatic nervous function and high risk of cardiovascular disease (CVD). Lower HRV in patients with severe secondary hyperparathyroidism (SHPT), a clinical manifestation of CKD-mineral and bone disorder (CKD-MBD), could be reversed by parathyroidectomy (PTX). It has been proved that leptin interacts with the autonomic nervous function. However, the associations between leptin and HRV in CKD patients and their longitudinal changes in SHPT patients after PTX are still unknown...
2016: American Journal of Nephrology
https://www.readbyqxmd.com/read/27589858/hypermethylation-of-the-casr-and-vdr-genes-in-the-parathyroid-glands-in-chronic-kidney-disease-rats-with-high-phosphate-diet
#20
Taketo Uchiyama, Norifumi Tatsumi, Sahoko Kamejima, Tsuyoshi Waku, Ichiro Ohkido, Keitaro Yokoyama, Takashi Yokoo, Masataka Okabe
Chronic kidney disease (CKD) disrupts mineral homeostasis and its representative pathosis is defined as secondary hyperparathyroidism (SHPT). SHPT occurs during the early course of progressive renal insufficiency, and is associated with mortality and cardiovascular events. SHPT results in reduction of calcium-sensing receptor (CaSR) and vitamin D receptor (VDR) in the parathyroid glands during CKD. However, the precise mechanism of CaSR and VDR reduction is largely unknown. CKD was induced through two-step 5/6 nephrectomy, and then CKD rats and sham-operated rats were maintained for 8 weeks on diets containing 0...
October 2016: Human Cell
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