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Abstract: PO0357

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

  • Fouqueray, Bruno, Amgen GmbH, Rotkreuz, Rotkreuz, Switzerland
  • Louie, Karly S., Amgen Ltd Uxbridge, Uxbridge, Middlesex, United Kingdom
  • Kohnle, Matthias, Nephrologisches Zentrum Mettmann, Gartenstrasse 8, Mettmann, Mettmann, Germany
  • Cejka, Daniel, Department of Medicine III, Division of Nephrology and Dialysis, Medical University Vienna, Vienna, Austria
  • Piccoli, Giorgina B., Nephrology, Centre Hospitalier Le Mans, Le Mans, France, Le Mans, France
  • Rix, Marianne, Department of Nephrology, University Hospital Copenhagen, Copenhagen, Denmark
  • Camerini, Corrado, Spedali Civili Brescia, Brescia, Brescia, Italy
  • Boots, Johannes Martinus maria, Department of Internal Medicine and Nephrology, Maasstad Hospital, the Netherlands, Rotterdam, Netherlands
  • Marn Pernat, Andreja, University Medical Center Ljubljana, Ljubljana, Ljubljana, Slovenia
  • Labriola, Laura, Department of Nephrology, Cliniques Universitaires Saint-Luc, Universite Catholique de Louvain, Brussels, Brussels, Belgium
  • Torregrosa, Jose-Vicente, Nephrology and Renal Transplant Department, Hospital Clinic, University of Barcelona, Barcelona, Barcelona, Spain
  • Nduka, Chidozie U., Amgen Ltd Uxbridge, Uxbridge, Middlesex, United Kingdom
  • Tsirtsonis, Kate, Amgen Ltd Uxbridge, Uxbridge, Middlesex, United Kingdom
  • Floege, Jürgen, Division of Nephrology, RWTH University of Aachen, Aachen, Germany
Background

Calcimimetics, oral cinacalcet (CIN) and intravenous etelcalcetide (ETEL), are approved for treating SHPT in adult patients on maintenance HD. Data on real-world use of calcimimetics 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 value (PTH) recorded within ≤90 days before calcimimetic initiation, were included. Data on demographics, clinical history, laboratory values and calcimimetic use were abstracted from medical charts.

Results

Interim data for 503 HD (96 CIN and 407 ETEL) patients from 57 sites across 12 countries are reported. At baseline, CIN patients had been calcimimetic naive while 45% (183/407) of ETEL patients had switched from CIN to ETEL (≤90 days from last CIN prescription). ETEL patients were younger than CIN (median: 63 vs. 69 yrs). Dialysis vintage was longer for ETEL patients (median: 5 vs. 2 yrs). Starting dose was 30 mg/day for 98% of CIN, and 5 mg and 2.5 mg thrice weekly for 58% and 41% of ETEL patients respectively. Table 1 summarizes median PTH and mean total calcium (Ca) and phosphate (P) levels. Among 341 ETEL and 79 CIN patients who had normal Ca at baseline, the cumulative incidence of hypocalcemia (<2.1 mmol/L) at 3 and 6 months was greater for CIN (47% and 58%) than ETEL (35% and 52%). As recorded in medical charts, nausea and vomiting rates at 12 months were similar for CIN (3.7% and 1.8%) and ETEL (3.6% and 1.9%). ETEL persistence (89.6%) was greater than CIN (71.8%) at 12 months. During follow-up, 13.5% switched from CIN to ETEL and 2.5% from ETEL to CIN. The proportion of patients achieving >30% reduction in PTH from baseline was greater for CIN than ETEL at 6 months (64% vs. 54%) but similar at 12 months (73% vs. 74%).

Conclusion

This is the largest real-world study on calcimimetics following 2016 approval of ETEL in Europe. There were marked reductions in PTH, Ca, and P levels. Gastrointestinal events did not differ between ETEL and CIN groups.

Funding

  • Commercial Support