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EARLIER: an observational study to evaluate the use of cinacalcet in incident hemodialysis patients with secondary hyperparathyroidism in daily clinical practice

EARLIER – Beobachtungsstudie zur Evaluierung der Verwendung von Cinacalcet bei inzidenten Hämodialysepatienten mit sekundärem Hyperparathyreoidismus in der klinischen Praxis

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Summary

The EARLIER (Evaluation of MimpARa in incident hemodiaLysis patIEnts with secondaRy hyperparathyroidism; SHPT) observational postmarketing surveillance study evaluated incident hemodialysis patients (< 1 year dialysis vintage; n = 146) receiving cinacalcet in Austrian clinical practice. Despite intervention with vitamin D sterols and phosphate binders, 24 % had already developed severe SHPT (intact parathyroid hormone (iPTH) > 800 pg/mL) at baseline. After cinacalcet was started, median iPTH decreased substantially, from 611 pg/mL to 251 pg/mL (median decrease 58 % [IQR − 36 to − 78 %] at 12 months. Overall, 36 % of patients achieved the Kidney Disease Outcomes Quality Initiative (K/DOQI) target range (150–300 pg/mL) for iPTH; this included 35 % of those with severe SHPT at baseline. Serum phosphorus (P), calcium (Ca) (corr), and Ca (corr) × P also decreased, with 43, 34, and 62 % of patients, respectively, reaching K/DOQI targets at 12 months. Thus, in this observational study, mineral metabolism in incident dialysis patients with SHPT improved after starting cinacalcet.

Zusammenfassung

Die EARLIER (Evaluation of MimpARa in incident hemodiaLysis patIEnts with secondaRy hyperparathyroidism; SHPT) Anwendungsbeobachtung nach Marktzulassung untersuchte inzidente Hämodialysepatienten (< 1 Jahr Dialysepflichtigkeit; n = 146) unter Cinacalcet-Therapie in der klinischen Praxis in Österreich. Trotz Behandlung mit Vitamin D und Phosphatbindern, hatten zu Baseline bereits 24 % einen schweren SHPT (iPTH > 800 pg/ml) entwickelt. Nach Beginn der Cinacalcet-Therapie sank der mediane iPTH substantiell von 611 pg/ml auf 251 pg/ml (medianer Abfall: 58 % [IQR − 36 bis − 78 %]) im Monat 12, wobei 36 % der Patienten den K/DOQI Zielbereich für iPTH (150–300 pg/ml) erreichten, einschließlich 35 % Patienten mit schwerem SHPT zu Baseline. Serum P, Ca (korrigiert) und Ca (korrigiert) × P sanken ebenfalls, wobei je 43, 34 und 62 % der Patienten im Monat 12 die K/DOQI Ziele erreichten. Zusammenfassend verbesserte sich in dieser Beobachtungsstudie der Mineralhaushalt bei inzidenten Hämodialysepatienten nach Cinacalcet-Therapiebeginn.

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Acknowledgements

Julia Balfour, medical writer/consultant, Dundee, UK, provided editorial support, with financial support from Amgen GmbH, Vienna, Austria.

Ethical standards statement

According to Austrian legislation neither ethics committee approval nor patients’ written informed consent was required for the conduction of non-interventional studies. The manuscript development followed the guidelines of the International Committee of Medical Journal Editors (ICMJE).

Conflict of interest

The EARLIER study was designed and funded by Amgen GmbH, Vienna, Austria. MH declares that she receives consulting fees from Amgen and holds Amgen stock. RO declares that he has received speaker’s honoraria from Amgen. HE declares that he is a consultant to Amgen. WP declares no conflict of interest.

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Correspondence to Wolfgang Pronai.

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Hemetsberger, M., Oberbauer, R., Erb, H. et al. EARLIER: an observational study to evaluate the use of cinacalcet in incident hemodialysis patients with secondary hyperparathyroidism in daily clinical practice. Wien Med Wochenschr 165, 410–418 (2015). https://doi.org/10.1007/s10354-015-0379-0

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  • DOI: https://doi.org/10.1007/s10354-015-0379-0

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