{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,30]],"date-time":"2026-09-30T04:41:50Z","timestamp":1790743310101,"version":"4.1.0"},"reference-count":15,"publisher":"MDPI AG","issue":"7","license":[{"start":{"date-parts":[[2019,7,20]],"date-time":"2019-07-20T00:00:00Z","timestamp":1563580800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["www.mdpi.com"],"crossmark-restriction":true},"short-container-title":["JCM"],"abstract":"<jats:p>Etelcalcetide is a new calcimimetic indicated for the treatment of secondary hyperparathyroidism (SHPT) in dialysis patients. Etelcalcetide efficacy in SHPT has been ascertained only in randomized controlled trials. This multicenter study was carried out in \u201creal world\u201d setting that is different from randomized controlled trials (RCTs) to (1) evaluate the effectiveness of etelcalcetide in SHPT, (2) to assess calcium, phosphorus, alkaline phosphatase changes, (3) to register gastrointestinal side effects. Data were collected from twenty-three dialysis units with n = 1190 patients on the charge. From this cohort, n = 168 (14%) patients were on treatment with etelcalcetide, and they were evaluated for statistics. A median weekly dose of etelcalcetide was 15 mg (7.5\u201345 mg). Patients were either na\u00efve (33%) or switched from cinacalcet to obtain better control of SHPT with reduced side effects or pills burden. Serum parathyroid hormone (PTH) declined over time from a median value of 636 pg\/mL to 357 pg\/mL. The median time for responders (intact PTH (iPTH) range: two to nine times the upper normal limit) was 53 days; the percentage of responders increased (from baseline 27% to 63%) being similar in switched-patients and na\u00efve-patients. Few patients had symptomatic hypocalcemia requiring etelcalcetide withdrawal (four cases (3%) at 30-day control, two cases (2%) at 60-day, one case (1%) at 90-day control). Side effects with etelcalcetide were lower (3\u20134%) than that registered during cinacalcet treatment (53%). Etelcalcetide is a new therapeutic option for SHPT with low side effects and pills burden. Etelcalcetide may improve adherence to therapy, avoiding unremitting SHP. It remains to be assessed whether etelcalcetide may reduce parathyroidectomy, vascular calcification, or mortality. Being etelcalcetide very potent in suppressing PTH levels, even in severe SHPT, future studies should evaluate the potential risk of more adynamic bone disease during long-term therapy.<\/jats:p>","DOI":"10.3390\/jcm8071066","type":"journal-article","created":{"date-parts":[[2019,7,22]],"date-time":"2019-07-22T02:55:37Z","timestamp":1563764137000},"page":"1066","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":20,"title":["Etelcalcetide in Patients on Hemodialysis with Severe Secondary Hyperparathyroidism. Multicenter Study in \u201cReal Life\u201d"],"prefix":"10.3390","volume":"8","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-0035-5712","authenticated-orcid":false,"given":"Domenico","family":"Russo","sequence":"first","affiliation":[{"name":"Department of Public Health, University of Naples FEDERICO II, 80131 Naples, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rocco","family":"Tripepi","sequence":"additional","affiliation":[{"name":"Institute of Clinical Physiology (IFC-CNR) Research Unit of Reggio Calabria, 89124 Reggio Calabria, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fabio","family":"Malberti","sequence":"additional","affiliation":[{"name":"Department of Nephrology Cremona Hospital, 26100 Cremona, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Biagio","family":"Di Iorio","sequence":"additional","affiliation":[{"name":"Department of Nephrology AORN Cardarelli, 80131 Naples, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bernadette","family":"Scognamiglio","sequence":"additional","affiliation":[{"name":"Department of Public Health, University of Naples FEDERICO II, 80131 Naples, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Luca","family":"Di Lullo","sequence":"additional","affiliation":[{"name":"Department of Nephrology Ospedale \u201cParodi Delfino\u201d di Colleferro (Roma), 00034 Colleferro, Roma, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Immacolata Gaia","family":"Paduano","sequence":"additional","affiliation":[{"name":"Department of Public Health, University of Naples FEDERICO II, 80131 Naples, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Giovanni Luigi","family":"Tripepi","sequence":"additional","affiliation":[{"name":"Institute of Clinical Physiology (IFC-CNR) Research Unit of Reggio Calabria, 89124 Reggio Calabria, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vincenzo Antonio","family":"Panuccio","sequence":"additional","affiliation":[{"name":"Nephrology, Dialysis and transplantation Unit G.O.M. \u201cBianchi Melacrino Morelli\u201d, 89121 Reggio Calabria, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2019,7,20]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","unstructured":"Kidney Disease: Improving Global Outcomes (KDIGO) CKD-MBD Update Work Group (2017). KDIGO 2017 Clinical Practice Guideline Update for the Diagnosis, Evaluation, Prevention, and Treatment of Chronic Kidney Disease\u2013Mineral and Bone Disorder (CKD-MBD). Kidney Int. Suppl., 7, 1\u201359.","DOI":"10.1016\/j.kisu.2017.04.001"},{"key":"ref_2","doi-asserted-by":"crossref","first-page":"146","DOI":"10.1001\/jama.2016.19456","article-title":"Effect of Etelcalcetide vs Placebo on Serum Parathyroid Hormone in Patients Receiving Hemodialysis With Secondary Hyperparathyroidism. Two Randomized Clinical Trials","volume":"317","author":"Block","year":"2017","journal-title":"JAMA"},{"key":"ref_3","doi-asserted-by":"crossref","first-page":"156","DOI":"10.1001\/jama.2016.19468","article-title":"Effect of Etelcalcetide vs Cinacalcet on Serum Parathyroid Hormone in Patients Receiving Hemodialysis. With Secondary Hyperparathyroidism","volume":"317","author":"Block","year":"2017","journal-title":"JAMA"},{"key":"ref_4","doi-asserted-by":"crossref","unstructured":"Bushinsky, D.A., Chertow, G.M., Cheng, S., Deng, H., Kopyt, N., Martin, K.J., Rastogi, A., Ure\u00f1a-Torres, P., Vervloet, M., and Block, G.A. (2019). One-year safety and efficacy of intravenous etelcalcetide in patients on hemodialysis with secondary hyperparathyroidism. Nephrol. Dial. Transplant., 1\u201310.","DOI":"10.1093\/ndt\/gfz039"},{"key":"ref_5","doi-asserted-by":"crossref","first-page":"1542","DOI":"10.1093\/ndt\/gfv099","article-title":"Improvement of mineral and bone metabolism markers is associated with better survival in haemodialysis patients: the COSMOS study","volume":"30","author":"Dionisi","year":"2015","journal-title":"Nephrol. Dial. Transplant."},{"key":"ref_6","doi-asserted-by":"crossref","first-page":"1179","DOI":"10.1111\/j.1523-1755.2005.00185.x","article-title":"Predictors and consequences of altered mineral metabolism: The Dialysis Outcomes and Practice Patterns Study","volume":"67","author":"Young","year":"2005","journal-title":"Kidney Int."},{"key":"ref_7","doi-asserted-by":"crossref","first-page":"519","DOI":"10.1053\/j.ajkd.2008.03.020","article-title":"Mortality risk for dialysis patients with different levels of serum calcium, phosphorus, and PTH: The Dialysis Outcomes and Practice Patterns Study (DOPPS)","volume":"52","author":"Tentori","year":"2008","journal-title":"Am. J. Kidney Dis."},{"key":"ref_8","doi-asserted-by":"crossref","first-page":"1718","DOI":"10.2215\/CJN.01040308","article-title":"Cinacalcet HCl and Concurrent Low-dose Vitamin D Improves Treatment of Secondary Hyperparathyroidism in Dialysis Patients Compared with Vitamin D Alone: The ACHIEVE Study Results","volume":"3","author":"Fishbane","year":"2008","journal-title":"Clin. J. Am. Soc. Nephrol."},{"key":"ref_9","doi-asserted-by":"crossref","first-page":"191","DOI":"10.1038\/ki.2013.289","article-title":"AMG 416 (velcalcetide) is a novel peptide for the treatment of secondary hyperparathyroidism in a single-dose study in hemodialysis patients","volume":"85","author":"Martin","year":"2013","journal-title":"Kidney Int."},{"key":"ref_10","doi-asserted-by":"crossref","first-page":"858","DOI":"10.1016\/j.jval.2017.03.008","article-title":"What Is Real-World Data? A Review of Definitions Based on Literature and Stakeholder Interviews","volume":"20","author":"Makady","year":"2017","journal-title":"Value Health"},{"key":"ref_11","doi-asserted-by":"crossref","first-page":"495","DOI":"10.1038\/nrd3501","article-title":"Bridging the efficacy-effectiveness gap: a regulator\u2019s perspective on addressing variability of drug response","volume":"10","author":"Eichler","year":"2011","journal-title":"Nat. Rev. Drug Discov."},{"key":"ref_12","doi-asserted-by":"crossref","first-page":"326","DOI":"10.1111\/j.1524-4733.2007.00186.x","article-title":"Using real world data for coverage and payment decisions: The ISPOR Real World Data Task Force Report","volume":"10","author":"Garrison","year":"2007","journal-title":"Value Health"},{"key":"ref_13","doi-asserted-by":"crossref","first-page":"673","DOI":"10.1093\/ndt\/gfy093","article-title":"Serum phosphate optimal timing and range associated with patients survival in haemodialysis: The COSMOS study","volume":"34","author":"Dusso","year":"2019","journal-title":"Nephrol. Dial. Transplant."},{"key":"ref_14","first-page":"862","article-title":"Adherence and persistence to prescribed medication therapy among Medicare part D beneficiaries on dialysis: comparisons of benefit type and benefit phase","volume":"20","author":"Park","year":"2014","journal-title":"J. Manag. Care Spec. Pharm."},{"key":"ref_15","doi-asserted-by":"crossref","first-page":"1319","DOI":"10.1124\/dmd.115.068007","article-title":"Nonclinical Pharmacokinetics, Disposition, and Drug-Drug Interaction Potential of a Novel d-Amino Acid Peptide Agonist of the Calcium-Sensing Receptor AMG 416 (Etelcalcetide)","volume":"44","author":"Subramanian","year":"2016","journal-title":"Drug Metab. Dispos."}],"updated-by":[{"DOI":"10.3390\/jcm9041224","type":"correction","label":"Correction","source":"publisher","updated":{"date-parts":[[2019,7,20]],"date-time":"2019-07-20T00:00:00Z","timestamp":1563580800000}}],"container-title":["Journal of Clinical Medicine"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.mdpi.com\/2077-0383\/8\/7\/1066\/pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,8,3]],"date-time":"2025-08-03T22:32:37Z","timestamp":1754260357000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.mdpi.com\/2077-0383\/8\/7\/1066"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2019,7,20]]},"references-count":15,"journal-issue":{"issue":"7","published-online":{"date-parts":[[2019,7]]}},"alternative-id":["jcm8071066"],"URL":"https:\/\/doi.org\/10.3390\/jcm8071066","relation":{"has-review":[{"id-type":"doi","id":"10.3410\/f.736246054.793577510","asserted-by":"object"}]},"ISSN":["2077-0383"],"issn-type":[{"value":"2077-0383","type":"electronic"}],"subject":[],"published":{"date-parts":[[2019,7,20]]}}}