FDA Approves Rayaldee (calcifediol) to Treat Secondary Hyperparathyroidism in Patients with Chronic Kidney Disease

MIAMI--(BUSINESS WIRE) June 21, 2016 -- OPKO Health, Inc. (NYSE:OPK) announced that the U.S. Food and Drug Administration (FDA) has approved Rayaldee (calcifediol) extended release capsules for the treatment of secondary hyperparathyroidism (SHPT)...
Source: Drugs.com - New Drug Approvals - Category: Drugs & Pharmacology Source Type: news

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Conclusions: (1) Six-month treatment based on cinacalcet seems to reduce oxidative stress markers in maintenance hemodialysis patients with sHPT. (2) This benefit may be related rather to the direct action of cinacalcet than to the serum PTH concentration decrease.Nephron
Source: Nephron - Category: Urology & Nephrology Source Type: research
Conclusion: Improving the gut environment using synbiotics ameliorated kidney function and might be a pharmacological treatment for SHPT without any serious adverse events.Am J Nephrol 2018;47:325 –332
Source: American Journal of Nephrology - Category: Neurology Source Type: research
CONCLUSION: Improving the gut environment using synbiotics ameliorated kidney function and might be a pharmacological treatment for SHPT without any serious adverse events. PMID: 29779028 [PubMed - as supplied by publisher]
Source: American Journal of Nephrology - Category: Urology & Nephrology Authors: Tags: Am J Nephrol Source Type: research
Authors: Bover J, Ureña-Torres P, Torregrosa JV, Rodríguez-García M, Castro-Alonso C, Górriz JL, Laiz Alonso AM, Cigarrán S, Benito S, López-Báez V, Lloret Cora MJ, daSilva I, Cannata-Andía J Abstract Osteoporosis (OP) and chronic kidney disease (CKD) independently influence bone and cardiovascular health. A considerable number of patients with CKD, especially those with stages 3a to 5D, have a significantly reduced bone mineral density leading to a high risk of fracture and a significant increase in associated morbidity and mortality. Independently of classic...
Source: Nefrologia : publicacion oficial de la Sociedad Espanola Nefrologia - Category: Urology & Nephrology Tags: Nefrologia Source Type: research
In chronic kidney disease (CKD), the progressive decrease in renal function leads to disturbances of mineral metabolism that generally cause secondary hyperparathyroidism. The increase in serum parathyroid hormone is associated with reduced serum calcium and calcitriol levels and/or increased serum fibroblast growth factor-23 and phosphate levels. The resulting CKD-associated disorder of mineral and bone metabolism is associated with various other metabolic dysregulations such as acidosis, malnutrition, inflammation, and accumulation of uremic toxins.
Source: Seminars in Nephrology - Category: Urology & Nephrology Authors: Source Type: research
This article describes the ERG’s review and critique of the company’s submission and summarises the NICE Appraisal Committee’s subsequent guidance (issued in June 2017). The clinical-effectiveness evidence submitted by the company consisted of two double-blind, randomised cont rolled trials (RCTs) comparing etelcalcetide with placebo, one RCT comparing etelcalcetide with cinacalcet, two single-arm extension studies of the above trials, and one single-arm study evaluating the effect of switching from cinacalcet to etelcalcetide. No study specifically examined the populatio n specified in the NICE appraisal...
Source: PharmacoEconomics - Category: Health Management Source Type: research
Brachyonychia is a rare manifestation in patients with chronic kidney disease. Longtime disease, secondary hyperparathyroidism, and hemodialysis are common conditions among those who present it. We evaluated 8 cases who presented brachyonychia in the nephrology department and compared the clinical versus the radiographic findings, and evaluated how the tissue adjusts to the underlying bone structure, giving different forms to the nails. We conclude that brachyonychia and acroosteolysis in chronic kidney disease suggest long-term disease, secondary hyperparathyroidism, and hemodialysis, besides it being a good model on how ...
Source: Skin Appendage Disorders - Category: Dermatology Source Type: research
Abstract More than half of all deaths among end stage renal disease (ESRD) patients are due to cardiovascular disease (CVD). Cardiovascular changes secondary to renal dysfunction, including fluid overload, uremic cardiomyopathy, secondary hyperparathyroidism, anemia, altered lipid metabolism, and accumulation of gut microbiota-derived uremic toxins like trimethylamine N-oxidase, contribute to the high risk for CVD in the ESRD population. In addition, conventional hemodialysis (HD) itself poses myocardial stress and injury on the already compromised cardiovascular system in uremic patients. This review will provide...
Source: Seminars in Dialysis - Category: Urology & Nephrology Authors: Tags: Semin Dial Source Type: research
Conclusion Tertiary hyperparathyroidism is a common finding in patients with prior secondary HPTH as seen in this patient, and needs to be treated surgically to manage all the symptoms and to prevent further complications.
Source: Current Medicine Research and Practice - Category: General Medicine Source Type: research
Authors: Cipriani C, Pepe J, Colangelo L, Minisola S Abstract The interplay between vitamin D and parathyroid hormone (PTH) represents one of the most important metabolic mechanisms of regulation of the calcium/phosphorus homeostasis. Secondary hyperparathyroidism is therefore a major complication that arises as a result of reduced vitamin D levels, both as primary 25-hydroxy-vitamin D (25[OH]D) and/or 1,25-dihydroxyvitamin D (1,25[OH]2D) reduction. Different metabolic pathways are involved, as well as target organs and tissues, with several clinical complications. The skeleton is primarily involved, but many other...
Source: Frontiers of Hormone Research - Category: Endocrinology Tags: Front Horm Res Source Type: research
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