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Etelcalcetide (calcimimetic) for the Treatment of Secondary Hyperparathyroidism (SHPT)

Etelcalcetide (formerly AMG416), an intravenous injectable calcimimetic agent, is currently under development by Amgen for the treatment of secondary hyperparathyroidism (SHPT) in patients with chronic kidney disease (CKD) on haemodialysis.
Source: Drug Development Technology - Category: Pharmaceuticals Source Type: news

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Parathyroidectomy (PTx) decreases the mortality rate of refractory secondary hyperparathyroidism (rSHP) due to chronic kidney disease. A consensus regarding which techniques of PTx are associated with better outcomes is not available. The aims of this study are to evaluate the clinical and laboratory evolution of 49 hemodialysis patients with rSHP who underwent PTx using different techniques.
Source: Surgery - Category: Surgery Authors: Tags: Original Communications Source Type: research
Conclusions Oral and maxillofacial manifestations of BTH and OF/RO are uncommon, but they can be associated with an important life-threatening scenario.
Source: Oral Surgery, Oral Medicine, Oral Pathology and Oral Radiology - Category: ENT & OMF Source Type: research
In conclusion, etelcalcetide and paricalcitol similarly atte nuated progression of SHPT in an adenine rat model of CKD. However, etelcalcetide differentially prevented vascular calcification, at least in part, due to reductions in serum FGF23, calcium, and phosphorus levels.
Source: Calcified Tissue International - Category: Orthopaedics Source Type: research
Conclusions Oral and maxillofacial manifestations of BTH and OF/RO are uncommon, but they can be associated with an important life threatening scenario.
Source: Oral Surgery, Oral Medicine, Oral Pathology and Oral Radiology - Category: ENT & OMF Source Type: research
ConclusionsIn hemodialysis patients, DP001 has a longer half-life than existing vitamin D therapies and enables control of parathyroid hormone when administered every 2 –3 days on the day of dialysis. It is effective at a lower concentration maximum and area under the curve than other clinically available vitamin D compounds. DP001 may represent a therapeutic improvement over existing compounds due to rapid and extensive distribution to its target and its long h alf-life enabling sustained parathyroid hormone suppression. These studies support further evaluation of DP001 in longer-term treatment of secondary hyperparathyroidism.
Source: Drugs in R&D - Category: Drugs & Pharmacology Source Type: research
We report here a case of severe SHPT in a hemodialysis patient treated with phosphate binders, calcitriol, and calcimimetics but who still required PTX. Severe hypocalcemia with muscle cramps occurred postoperatively. Around 1 year after PTX, anemia and features of SHPT have improved but the patient still has intermittent hypocalcemia with suspected postoperative hypoparathyroidism. Regular comprehensive assessment of calcium and phosphorus levels throughout all stages of chronic kidney disease is vital. The postoperative period of PTX in SHPT patients is critical, requiring monitoring to improve management.Blood Purif 2017;44(suppl 1):35-40
Source: Blood Purification - Category: Hematology Source Type: research
AbstractObjectivesSecondary hyperparathyroidism (SHPT) is a disease that affects patients with chronic kidney disease, and is characterized by mineral disturbance and bone loss, known as renal osteodystrophy. The aim of this study was to assess the validity of using intraoral phosphor storage plates to take radiographs of the middle phalanges to evaluate bone loss resulting from SHPT during follow-up of these patients.MethodsThe sample consisted of 24 patients with chronic kidney disease, 12 with parathyroid hormone (PTH) levels ≥500 pg/ml, and 12 with PTH levels
Source: Oral Radiology - Category: Radiology Source Type: research
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.
Source: Bone - Category: Orthopaedics Authors: Source Type: research
ConclusionsEtelcalcetide effectively maintained serum iPTH, calcium, and phosphate levels in appropriate ranges with concomitant medications for SHPT for 52  weeks in Japanese hemodialysis patients, and was safe and well tolerated.Registration NumberJapicCTI-142665.
Source: Clinical and Experimental Nephrology - Category: Urology & Nephrology Source Type: research
ConclusionsThe current analysis confirms the putative mechanism of action of etelcalcetide as an allosteric activator of CaSR. Simulations showed that dose titration of etelcalcetide, rather than fixed dose, is needed to effectively decrease the PTH level in patient populations.
Source: Clinical Pharmacokinetics - Category: Drugs & Pharmacology Source Type: research
More News: Chronic Kidney Disease | Dialysis | Hemodialysis | Hyperparathyroidism | Pharmaceuticals | Urology & Nephrology