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Abstract: PO0547

A Real-World Observational Study of Calcimimetic Use in Hemodialysis (HD) Patients with Secondary Hyperparathyroidism (SHPT) in Europe

Session Information

Category: Bone and Mineral Metabolism

  • 402 Bone and Mineral Metabolism: Clinical

Authors

  • Nduka, Chidozie U., Amgen, Uxbridge, United Kingdom
  • Marn Pernat, Andreja, University Medical Center Ljubljana, Ljubljana, Slovenia
  • Camerini, Corrado, Spedali Civili Brescia, Brescia, Italy
  • Cejka, Daniel, Medizinische Universitat Wien, Wien, Wien, Austria
  • Ladanyi, Erzsebet, Fresenius Medical Care Dialysis Centre, Miskolc, Hungary
  • Piccoli, Giorgina B., Centre Hospitalier du Mans, Le Mans, France
  • Boots, Johannes Martinus maria, Maasstad Ziekenhuis, Rotterdam, Zuid-Holland, Netherlands
  • Torregrosa, Jose-Vicente, Hospital Clinic, University of Barcelona, Barcelona, Spain
  • Labriola, Laura, Cliniques Universitaires Saint-Luc, Université Catholique de Louvain, Brussels, Belgium
  • Rix, Marianne, University Hospital Copenhagen Rigshospitalet, Copenhagen, Denmark
  • Hall, Matthew, Nottingham City Hospital, Nottingham, Nottingham, United Kingdom
  • Kohnle, Matthias, Nephrologisches Zentrum Mettmann, Mettmann, Germany
  • Tsirtsonis, Kate, Amgen, Uxbridge, United Kingdom
  • Fouqueray, Bruno L., Amgen GmbH, Rotkreuz, Switzerland
  • Floege, Jürgen, Rheinisch-Westfalische Technische Hochschule Aachen, Aachen, Nordrhein-Westfalen, Germany
Background

Calcimimetics, Cinacalcet (CIN) and Etelcalcetide (ETEL), are approved for treating SHPT in adult patients on maintenance HD. Data on real-world use are needed to provide guidance in clinical practice.

Methods

In this observational study, chronic HD patients treated with calcimimetics for SHPT with ≥1 parathyroid hormone (PTH) measurement recorded within 90 days before calcimimetic initiation were included. Medical history, PTH, calcium (Ca) and phosphate (P) measurements, and calcimimetic use data were extracted from medical charts. Baseline period was defined as 6 months before calcimimetic initiation.

Results

Interim data for 974 HD (198 CIN and 776 ETEL) patients across 15 countries in Europe, recorded from June 2018 to March 2021, are reported. 43% (334/776) of ETEL patients had switched within 90 days after stopping CIN. ETEL patients were younger than CIN (median age: 62 vs. 65 yrs.). Dialysis vintage was longer for ETEL than CIN patients (median: 4.4 vs. 2 yrs.). Starting dose was 30 mg for 95% of CIN; and 5 mg and 2.5 mg for 58% and 40% of ETEL patients respectively. At 12 months, median PTH had decreased by 41% in ETEL and 31% in CIN patients (Table 1), however 54% of ETEL and 57% of CIN patients achieved target PTH range (150-600 pg/mL). The cumulative incidence of hypocalcemia (Ca <2.1 mmol/L) at 6 months (66% vs. 59%) was higher in CIN than ETEL patients, but no difference was recorded at 12 months (74% vs. 73%). As recorded in medical charts, nausea (2.2% vs. 2%) and vomiting (0 vs. 1.3%) were low for CIN and ETEL patients. ETEL persistence (88%) was greater than CIN (76%) at 12 months. 16% switched from CIN to ETEL and 2% from ETEL to CIN during follow-up.

Conclusion

ETEL and CIN patients achieved target PTH range to a similar degree at 12 months, however PTH decrease over time was better in ETEL patients. Treatment persistence was higher with ETEL than CIN. No new safety signals were observed.

Funding

  • Commercial Support