Long-term use of etelcalcetide for the treatment of secondary hyperparathyroidism in patients undergoing hemodialysis for end-stage renal failure: a real-life retrospective observational study

• Published in: International urology and nephrology Vol. 55; no. 7; pp. 1865 - 1873
• Main Authors: Morosetti, Massimo, Jankovic, Ljiljana, Zappalà, Laura, Agafonova, Elena, Pryshlyak, Iryna
• Format: Journal Article
• Language: English
• Published: Dordrecht Springer Netherlands 01.07.2023; Springer Nature B.V
• Subjects: Calcimimetic Agents - therapeutic use; Calcium; Cinacalcet - therapeutic use; Clinical trials; End-stage renal disease; Hemodialysis; Humans; Hyperparathyroidism; Hyperparathyroidism, Secondary - drug therapy; Hyperparathyroidism, Secondary - etiology; Kidney diseases; Kidney Failure, Chronic - complications; Kidney Failure, Chronic - therapy; Medicine; Medicine & Public Health; Nephrology; Nephrology - Original Paper; Observational studies; Parathyroid Hormone; Renal Dialysis - adverse effects; Renal failure; Urology; Vitamin D; Etelcalcetide; Secondary hyperparathyroidism; CKD-MBD; Calcimimetics
• ISSN: 1573-2584; 0301-1623; 1573-2584
• DOI: 10.1007/s11255-023-03505-4

Background Patients with end-stage renal failure (ESRD) or dialysis frequently suffer from secondary hyperparathyroidism (sHPTH), a severe complication of mineral metabolism disorders. The calcimimetic etelcalcetide has been approved and shown efficacy in randomized controlled trials, however, data are limited from real-life studies. This study aimed to evaluate the long-term use etelcalcetide for the treatment of sHPTH (PTH > 600 pg/mL) in patients undergoing extracorporeal hemodialysis for ESRD for at least 2 years. Methods In 45 patients, we administered etelcalcetide for the treatment of sHPTH (PTH > 600 pg/mL); One group of patients (control group, Group A; N  = 26) were previously treated with intravenous vitamin D analogues only (paricalcitol 5 µg/ml, three times/week) and then treated with etelcalcetide and a second group of patients already on cinacalcet therapy for at least six months in combination with iv paricalcitol were switched to etelcalcetide (Group B, N  = 19). Results PTH levels decreased over time in both groups of patients, with higher values for patients previously treated with cinacalcet (Group B) compared to Group A for the entire study duration even if the final value of the two groups was comparable. After 12 months, the percentage of subjects who had PTH concentrations within the targets recommended by KDIGO guidelines was 87% in Group A and 58% in Group B. In seven patients, despite a parathyroid gland volume > 1000 mm 3 , an adequate response in the reduction of PTH was obtained. Conclusion Findings from this study demonstrate that the efficacy of etelcalcetide is maintained over the long term.