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Effective use of cinacalcet for the treatment of secondary hyperparathyroidism in Austrian dialysis patients – Results of the Austrian cohort of the ECHO study

Erfolgreicher Einsatz von Cinacalcet in der Therapie des sekundären Hyperparathyreoidismus bei österreichischen Dialysepatienten – Ergebnisse der österreichischen Kohorte der ECHO-Studie

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Zusammenfassung

HINTERGRUND: Trotz extensiven Einsatzes der vorhandenen Standardtherapeutika befindet sich der Großteil der österreichischen Dialysepatienten mit sekundärem Hyperparathyreoidismus (sHPT) außerhalb der empfohlenen Therapieziele. In einer pan-europäischen Beobachtungsstudie (ECHO) wurde die Effizienz des Kalzimimetikums Cinacalcet in der Therapie des sHPT in der realen klinischen Praxis untersucht. In dieser Arbeit wird die Subanalyse der österreichischen Studienkohorte präsentiert. METHODIK: In die Studie wurden erwachsene Dialysepatienten, bei denen eine Therapie mit Cinacalcet begonnen worden war, eingeschlossen. Biochemische Parameter des Knochen- und Mineralstoffwechsels (intaktes Parathormon [iPTH], Kalzium [Ca] und Phosphat [P]) sowie die Begleitmedikation wurden 6 Monate vor Beginn der Cinacalcettherapie, zum Zeitpunkt des Beginns (Baseline) und schließlich bis zu 12 Monate nach Beginn der Cinacalcettherapie erfasst. ERGEBNISSE: Insgesamt wurden 320 Patienten (mittleres Alter (±SD): 56 (±14) Jahre) in 34 österreichischen Dialysezentren eingeschlossen. Zur Baseline präsentierten sich die Patienten mit erhöhtem iPTH (Median 605 pg/ml) und Hyperphosphatämie (Median 2.1 mmol/l). Nach 12-monatiger Cinacalcettherapie fand sich eine Reduktion der Serumspiegel von iPTH (mediane prozentuelle Abnahme –48 %), Kalzium (–2 %) und Phosphat (–6 %). Die deutlichste iPTH-Abnahme (–66 %) ließ sich bei Patienten mit am stärksten ausgeprägtem sHPT (iPTH >800 pg/ml bei Cinacalcettherapiebeginn) beobachten. Der Anteil der die empfohlenen NKF/K-DOQI™Therapieziele erreichenden Patienten erhöhte sich während der Therapiephase bis zum Monat 12 für iPTH (von 3 % auf 36 %) und Phosphat (von 24 % auf 39 %) und blieb für Kalzium konstant (von 51 % auf 50 %). Zu Studienbeginn fand sich kein Patient mit allen 3 Parametern gleichzeitig innerhalb der NKF/K-DOQI™ Therapieziele, nach 12 Monaten erreichten 7 % dieses Therapieziel. Während der Beobachtungszeit änderte sich der anteilsmäßige Einsatz des Phosphatbinders Sevelamer nicht, während der Einsatz kalziumhältiger Phosphatbinder anstieg und jener aluminiumbasierter abnahm. Hinsichtlich des Einsatzes von Vitamin D Analoga ergab sich keine wesentliche Änderung im Studienverlauf. SCHLUSSFOLGERUNG: Der zusätzliche Einsatz von Cinacalcet verbesserte die Kontrolle der Knochen- und Mineralstoffwechselparameter und ermöglichte einem größeren Anteil an österreichischen Dialysepatienten, die empfohlenen KDOQI™ Therapieziele für Serum iPTH, Kalzium und Phosphat zu erreichen.

Summary

BACKGROUND: Despite extensive use of standard therapy for secondary hyperparathyroidism (sHPT) in dialysis patients, still most patients do not achieve the recommended treatment targets. In a pan-European observational study (ECHO), the effectiveness of the calcimimetic cinacalcet for the treatment of sHPT was evaluated in real-world clinical practice. A sub-analysis of the entire Austrian study cohort is presented. METHODS: Adult dialysis patients who had initiated cinacalcet therapy were included. Data on biochemical parameters of bone and mineral metabolism (intact parathyroid hormone [iPTH], calcium [Ca] and phosphorus [P]) and concurrent medication were collected 6 months prior to the initiation of cinacalcet, at initiation (baseline) and after up to 12 months of active treatment. RESULTS: A total of 320 patients (mean age (±SD): 56 (±14) years) from 34 Austrian dialysis centres were enrolled. At baseline, patients presented with elevated serum iPTH (median 605 pg/ml) and hyperphosphataemia (median 2.1 mmol/l). After 12 months of cinacalcet treatment, serum iPTH (median percentage change –48%), calcium (–2%) and phosphorus (–6%) decreased. The greatest iPTH reduction (–66%) was found in patients with most severe sHPT (>800 pg/ml at baseline). The proportion of patients achieving the recommended NKF/K-DOQI™ treatment targets increased from baseline to month 12 for iPTH (3–36%) and phosphorus (24 to 39%) and remained stable for calcium (51 to 50%), respectively. No patient had all 3 parameters simultaneously within NKF/K-DOQI™ treatment targets at baseline, while 7% of patients achieved this treatment goal after 12 months. During the study the use of the phosphate binder sevelamer remained fairly stable, while the relative percentage use of calcium-based phosphate binders increased and the usage of aluminium-containing binders decreased; vitamin D analogue use remained stable. CONCLUSION: Additional use of cinacalcet improved biochemical parameters of bone and mineral metabolism and enabled more patients to achieve and maintain the KDOQI™ treatment targets for serum iPTH, calcium and phosphorus.

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Authors and Affiliations

  1. Department of Nephrology and Dialysis, LKH Feldkirch, Feldkirch, Austria

    Emanuel Zitt

  2. Amgen GmbH, Vienna, Austria

    Christine Jäger

  3. Department of Internal Medicine IV, Nephrology and Hypertension, Innsbruck Medical University, Innsbruck, Austria

    Alexander R. Rosenkranz

  4. Department of Internal Medicine I, SMZ Süd – Kaiser Franz Josef Spital Vienna, Vienna, Austria

    Manfred Eigner

  5. Department of Internal Medicine III, Nephrology and Dialysis, Medical University Vienna, Vienna, Austria

    Katharina Kodras & Bruno Watschinger

  6. Department of Internal Medicine 6 – Nephrology and Dialysis, Wilhelminenspital der Stadt Wien, Vienna, Austria

    Josef Kovarik

  7. Department of Internal Medicine III, KA Rudolfstiftung, Vienna, Austria

    Helmut Graf

  8. Amgen, Uxbridge, UK

    Frank Pétavy

  9. Division for Nephrology and Haemodialysis, Department for Internal Medicine, Medical University Graz, Graz, Austria

    Sabine Horn

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  1. Emanuel Zitt
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Zitt, E., Jäger, C., Rosenkranz, A. et al. Effective use of cinacalcet for the treatment of secondary hyperparathyroidism in Austrian dialysis patients – Results of the Austrian cohort of the ECHO study. Wien Klin Wochenschr 123, 45–52 (2011). https://doi.org/10.1007/s00508-010-1515-x

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