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https://www.readbyqxmd.com/read/28508378/population-pharmacokinetic-and-pharmacodynamic-modeling-of-etelcalcetide-in-patients-with-chronic-kidney-disease-and-secondary-hyperparathyroidism-receiving-hemodialysis
#1
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/28508128/the-cardiothoracic-ratio-and-all-cause-and-cardiovascular-disease-mortality-in-patients-undergoing-maintenance-hemodialysis-results-of-the-mbd-5d-study
#2
Hiroaki Ogata, Junji Kumasawa, Shingo Fukuma, Masahide Mizobuchi, Eriko Kinugasa, Masafumi Fukagawa, Shunichi Fukuhara, Tadao Akizawa
BACKGROUND: The cardiothoracic ratio (CTR) is a non-invasive left ventricular hypertrophy index. However, whether CTR associates with cardiovascular disease (CVD) and mortality in hemodialysis (HD) populations is unclear. METHODS: Using a Mineral and Bone disorder Outcomes Study for Japanese CKD Stage 5D Patients (MBD-5D Study) subcohort, 2266 prevalent HD patients (age 62.8 years, female 38.0%, HD duration 9.4 years) with secondary hyperparathyroidism (SHPT) whose baseline CTR had been recorded were selected...
May 15, 2017: Clinical and Experimental Nephrology
https://www.readbyqxmd.com/read/28499709/mortality-in-dialysis-patients-with-cinacalcet-use-a-large-observational-registry-study
#3
Claudia Friedl, Gilbert Reibnegger, Reinhard Kramar, Emanuel Zitt, Stefan Pilz, Johannes F E Mann, Alexander R Rosenkranz
BACKGROUND: Secondary hyperparathyroidism (sHPT) is associated with higher mortality in dialysis patients. The calcimimetic cinacalcet reduces intact parathyroid hormone (iPTH) in dialysis patients. The randomized controlled EVOLVE trial failed to unequivocally prove survival advantage of cinacalcet in dialysis patients. However, recent post hoc analyses suggested a benefit in subgroups of dialysis patients. Large observational cohort studies may represent an option to better determine such subgroups...
May 9, 2017: European Journal of Internal Medicine
https://www.readbyqxmd.com/read/28451892/oral-paricalcitol-expanding-therapeutic-options-for-pediatric-chronic-kidney-disease-patients
#4
EDITORIAL
Michael Freundlich, Carolyn L Abitbol
The complex pathophysiology of progressive chronic kidney disease (CKD) and the development of mineral and bone disorder, abbreviated as CKD-MBD, is of vital importance to a pediatric patient. Paricalcitol, the 19 nor-1,25(OH)2D2 analogue was shown to be effective and safe in the treatment of secondary hyperparathyroidism (SHPT) in adults almost two decades ago. It also significantly improved survival in dialysis patients compared to the standard calcitriol. The successful treatment of CKD-MBD in children is essential if they are to grow and survive into adulthood...
April 27, 2017: Pediatric Nephrology: Journal of the International Pediatric Nephrology Association
https://www.readbyqxmd.com/read/28445401/tradeoff-in-the-nephron-a-theory-to-explain-the-primacy-of-phosphate-in-the-pathogenesis-of-secondary-hyperparathyroidism
#5
Kenneth R Phelps
Chronic kidney disease (CKD) causes secondary hyperparathyroidism (SHPT). The cardinal features of SHPT are persistence of normocalcemia as CKD progresses and dependence of the parathyroid hormone concentration ([PTH]) on phosphate influx (IP). The tradeoff-in-the-nephron hypothesis integrates these features. It states that as the glomerular filtration rate (GFR) falls, the phosphate concentration ([P]CDN) rises in the cortical distal nephron, the calcium concentration ([Ca]CDN) in that segment falls, and [PTH] rises to maintain normal calcium reabsorption per volume of filtrate (TRCa/GFR)...
April 26, 2017: Nutrients
https://www.readbyqxmd.com/read/28429545/do-the-benefits-of-using-calcitriol-and-other-vitamin-d-receptor-activators-in-patients-with-chronic-kidney-disease-outweigh-the-harms
#6
Nigel D Toussaint, Matthew J Damasiewicz
The primary indication for administration of calcitriol or other vitamin D receptor activators (VDRA) in chronic kidney disease (CKD) is secondary hyperparathyroidism (SHPT). Prevention and treatment of SHPT appears important, as imbalances in mineral metabolism are associated with renal osteodystrophy, and higher parathyroid hormone (PTH) levels are associated with increased rates of mortality and morbidity in CKD patients. There is, however, a lack of controlled trial data that show lowering PTH with calcitriol/VDRA equates to improved clinical outcomes...
March 2017: Nephrology
https://www.readbyqxmd.com/read/28384171/the-shift-from-high-to-low-turnover-bone-disease-after-parathyroidectomy-is-associated-with-the-progression-of-vascular-calcification-in-hemodialysis-patients-a-12-month-follow-up-study
#7
Fabiana Rodrigues Hernandes, Maria Eugênia Fernandes Canziani, Fellype Carvalho Barreto, Rodrigo Oliveira Santos, Valéria de Melo Moreira, Carlos Eduardo Rochitte, Aluizio Barbosa Carvalho
Parathyroidectomy (PTX) may cause low levels of PTH, leading to an excessive reduction of bone turnover, which is associated with poor outcomes in dialysis patients, including vascular calcification (VC). We aimed to prospectively investigate the impact of PTX on bone remodeling and its potential consequence on the progression of VC in hemodialysis patients. In this prospective study, 19 hemodialysis patients with severe secondary hyperparathyroidism (sHPT) were evaluated. All patients underwent laboratorial tests and coronary tomography at baseline and, 6 and 12 months after PTX; bone biopsy was performed at baseline and 12-month...
2017: PloS One
https://www.readbyqxmd.com/read/28375871/resurgence-of-parathyroidectomy-evidence-and-outcomes
#8
Hirotaka Komaba, Michio Nakamura, Masafumi Fukagawa
PURPOSE OF REVIEW: Parathyroidectomy (PTx) is the definitive therapy for refractory secondary hyperparathyroidism (SHPT). The drastic effects of PTx on biochemical parameters of SHPT increases the possibility that this intervention will lead to a reduction in the adverse outcomes related to uncontrolled SHPT. RECENT FINDINGS: The effect of PTx on mortality and cardiovascular outcomes among dialysis patients with severe SHPT have been evaluated in many observational studies from different regions of the world, including Asia, Europe, North America, and South America...
April 1, 2017: Current Opinion in Nephrology and Hypertension
https://www.readbyqxmd.com/read/28348181/trajectories-of-ckd-mbd-biochemical-parameters-over-a-2-year-period-following-diagnosis-of-secondary-hyperparathyroidism-a-pharmacoepidemiological-study
#9
Pierre Filipozzi, Carole Ayav, Willy Ngueyon Sime, Emmanuelle Laurain, Michèle Kessler, Laurent Brunaud, Luc Frimat
OBJECTIVES: To define groups of patients according to the changes of biochemical parameters, that is, serum calcium, phosphate and parathyroid hormone (PTH), over a 2-year follow-up period using group-based multi-trajectory modeling (GBMM) among a cohort of dialysis patients with newly diagnosed secondary hyperparathyroidism (SHPT) (ie, PTH≥500 ng/L for the first time) and to compare their patient characteristics and treatments. DESIGN: Pharmacoepidemiological study...
March 27, 2017: BMJ Open
https://www.readbyqxmd.com/read/28346348/vitamin-d-in-chronic-kidney-disease-and-dialysis-patients
#10
REVIEW
Guillaume Jean, Jean Claude Souberbielle, Charles Chazot
Vitamin D deficiency (<20 ng/mL) and insufficiency (20-29 ng/mL) are common among patients with chronic kidney disease (CKD) or undergoing dialysis. In addition to nutritional and sunlight exposure deficits, factors that affect vitamin D deficiency include race, sex, age, obesity and impaired vitamin D synthesis and metabolism. Serum 1,25(OH)₂D levels also decrease progressively because of 25(OH)D deficiency, together with impaired availability of 25(OH)D by renal proximal tubular cells, high fibroblast growth factor (FGF)-23 and decreased functional renal tissue...
March 25, 2017: Nutrients
https://www.readbyqxmd.com/read/28336830/-the-discovery-research-and-development-of-etelcalcetide-hydrochloride-the-world-1st-intravenous-calcimimetics
#11
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/28336827/-pathophysiology-of-secondary-hyperparathyroidism
#12
Hiroo Kawarazaki
Secondary hyperparathyroidism(SHPT)is the result of a compensatory response of the calcium phosphate homeostatic mechanism. Vitamin D deficiency and chronic kidney disease, both representative pathophysiological causes of SHPT, have been related not only to skeletal disorders but also cardiovascular diseases, ADL and QOL. This relates the importance of SHPT as a pathological cause or marker of such states.
2017: Clinical Calcium
https://www.readbyqxmd.com/read/28277829/etelcalcetide-for-the-treatment-of-secondary-hyperparathyroidism
#13
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/28078796/hyperparathyroidism-caused-by-distant-pulmonary-lesions-and-parathyromatosis-after-ethanol-injection-parathyroidectomy-for-secondary-hyperparathyroidism
#14
Michio Nakamura, Kiho Tanaka, Takeshi Fujii
Secondary hyperparathyroidism (SHPT) treatment includes parathyroidectomy and percutaneous ethanol injection therapy (PEIT), which are invasive procedures. The condition in which benign hyperfunctioning parathyroid tissue is distributed throughout the neck and mediastinum is termed parathyromatosis. Here, we present the case of a 51-year-old woman who began hemodialysis in 1986 due to chronic kidney disease of unknown etiology and developed SHPT in 1999. She underwent 6 rounds of PEIT followed by total a parathyroidectomy with partial forearm autotransplantation...
January 11, 2017: Hemodialysis International
https://www.readbyqxmd.com/read/28073343/risk-factors-and-clinical-course-of-hungry-bone-syndrome-after-total-parathyroidectomy-in-dialysis-patients-with-secondary-hyperparathyroidism
#15
Lo-Yi Ho, Ping-Nam Wong, Ho-Kwan Sin, Yuk-Yi Wong, Kwok-Chi Lo, Shuk-Fan Chan, Man-Wai Lo, Kin-Yee Lo, Siu-Ka Mak, Andrew Kui-Man Wong
BACKGROUND: Hungry bone syndrome (HBS) is an important postoperative complication after parathyroidectomy for severe secondary hyperparathyroidism (SHPT). There is, however, little data in the literature on its detailed clinical course, and the associated risk factors remain controversial. METHODS: We did a single-center retrospective study on 62 consecutive dialysis patients who underwent total parathyroidectomy for SHPT to examine the risk factors, clinical course and outcome...
January 10, 2017: BMC Nephrology
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
#16
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/28044233/management-of-secondary-hyperparathyroidism-how-and-why
#17
REVIEW
Hirotaka Komaba, Takatoshi Kakuta, Masafumi Fukagawa
Secondary hyperparathyroidism (SHPT) is a common complication in chronic kidney disease. Currently, various treatment options are available, including vitamin D receptor activators, cinacalcet hydrochloride, and parathyroidectomy. These treatment options have contributed to the successful control of SHPT, and recent clinical studies have provided evidence suggesting that effective treatment of SHPT leads to improved survival. Although bone disease is the most widely recognized consequence of SHPT and remains a major target for treatment of SHPT, there is increasing evidence that parathyroid hormone (PTH) and fibroblast growth factor 23 (FGF23), both of which are markedly elevated in SHPT, have multiple adverse effects on extraskeletal tissues...
March 2017: Clinical and Experimental Nephrology
https://www.readbyqxmd.com/read/28005175/research-on-kidney-and-mineral-metabolism-in-japan-past-present-and-future
#18
REVIEW
Masahide Mizobuchi, Hiroaki Ogata, Fumihiko Koiwa, Eriko Kinugasa, Tadao Akizawa
Since the identification of the kidney was the main site for the synthesis of calcitriol (1α, 25-dihydroxycholecalciferol), research on chronic kidney disease (CKD)-associated mineral metabolism disorders and their management has made rapid progress. Various active analogues of calcitriol have clinically become available for treating secondary hyperparathyroidism (SHPT), which is a representative mineral metabolism abnormality in CKD patients. A calcimimetic compound cinacalcet hydrochloride has also been developed for the medical management of SHPT through a different mechanism involving the calcium-sensing receptor...
March 2017: Clinical and Experimental Nephrology
https://www.readbyqxmd.com/read/27989797/vitamin-d-receptor-agonist-vs-105-directly-modulates-parathyroid-hormone-expression-in-human-parathyroid-cells-and-in-5-6-nephrectomized-rats
#19
Kaichiro Sawada, J Ruth Wu-Wong, Yung-Wu Chen, Jerry L Wessale, Genta Kanai, Takatoshi Kakuta, Masafumi Fukagawa
Vitamin D receptor (VDR) agonists (VDRAs) are commonly used to treat secondary hyperparathyroidism (SHPT) associated with chronic kidney disease (CKD). Current VDRA therapy often causes hypercalcemia, which is a critical risk for vascular calcification. Previously we have shown that a novel VDRA, VS-105, effectively suppresses serum parathyroid hormone (PTH) without affecting serum calcium levels in 5/6 nephrectomized (NX) uremic rats. However, it is not known whether VS-105 directly regulates PTH gene expression...
March 2017: Journal of Steroid Biochemistry and Molecular Biology
https://www.readbyqxmd.com/read/27971362/exploring-the-potential-value-of-improved-care-for-secondary-hyperparathyroidism-shpt-with-a-novel-investigational-calcimimetic-therapy
#20
B Stollenwerk, S Iannazzo, K Cooper, 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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