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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

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Abstract

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 mm3, 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.

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Data availability

The data supporting our fndings are presented in the article. The datasets of the current study are available from the corresponding author on reasonable request.

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Acknowledgements

Authors wish to thank Dr Colin Gerard Egan (CE Medical Writing SRLS, Pisa, Italy) for revising the manuscript.

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Authors and Affiliations

  1. Nefrologia e Dialisi, Ospedale GB Grassi, Asl Roma 3, Via Giancarlo Passeroni 28, 00122, Rome, Italy

    Massimo Morosetti, Ljiljana Jankovic, Laura Zappalà, Elena Agafonova & Iryna Pryshlyak

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  1. Massimo Morosetti
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  2. Ljiljana Jankovic
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  3. Laura Zappalà
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Contributions

All authors MM, LJ, LZ, EA, IP, contributed equally to each of the following (a-f). (a) the design of the study, (b) collected data, (c) performed statistical analysis (d) interpreted results (e) wrote the manuscript and (f) read and approved the final version of the manuscript.

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Correspondence to Massimo Morosetti.

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Morosetti, M., Jankovic, L., Zappalà, L. et al. 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. Int Urol Nephrol 55, 1865–1873 (2023). https://doi.org/10.1007/s11255-023-03505-4

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