NDT Advance Access published online on April 15, 2009
Nephrology Dialysis Transplantation, doi:10.1093/ndt/gfp144
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Cinacalcet and achievement of the NKF/K-DOQITM recommended target values for bone and mineral metabolism in real-world clinical practice—the ECHO observational study
1 Clinique du Landy, Saint Ouen, France 2 Danderyd Hospital and Karolinska Institute, Stockholm, Sweden 3 Academic Teaching Hospital, Feldkirch, Austria 4 VU Medisch Centrum, Amsterdam, The Netherlands 5 AO Istituti Ospitalieri di Cremona, Cremona, Italy 6 The Royal London Hospital, London, UK 7 Waterford Regional Hospital, Waterford, Ireland 8 University Hospital, Copenhagen, Denmark 9 Ullevål University Hospital, University of Oslo, Oslo, Norway 10 Tampere University Hospital, Tampere, Finland 11 Krajska Nemocnice Liberec, Liberec, Czech Republic 12 DIA_NE sro, Nitra, Slovakia 13 Amgen Europe GmBH, Zug, Switzerland 14 Hôpital Edouard Herriot, University Lyon 1, France
Correspondence and offprint requests to: Pablo Ureña; E-mail: urena.pablo{at}wanadoo.fr
| Abstract |
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Background. The use and effectiveness of cinacalcet in real-world clinical practice was investigated in a pan-European observational study in dialysis patients with secondary hyperparathyroidism (SHPT) of varying severity.
Methods. Adult patients with chronic kidney disease on dialysis who had initiated cinacalcet treatment were enrolled. Data were collected 6 months before initiating cinacalcet, at baseline (initiation of cinacalcet) and up to 12 months after cinacalcet initiation.
Results. A total of 1865 patients [mean (SD) age 58 (15) years] were enrolled from 187 sites in 12 countries. Most patients had a dialysis vintage of
1 year (1–5 years, n = 833; >5 years, n = 748 versus <1 year, n = 265). The patients generally had severely uncontrolled intact parathyroid hormone (iPTH) serum levels (median 721 pg/ml) and elevated phosphorus (median 5.9 mg/dl) and calcium (median 9.6 mg/dl) at baseline, despite being prescribed conventional therapies. The proportions of patients achieving the recommended [NKF-K/DOQITM (KDOQITM)] targets increased from baseline [4%, 39%, 40% and 46% for iPTH, phosphorus, calcium and calcium–phosphorus product (Ca x P), respectively] to Month 12 (28%, 48%, 51% and 68%, respectively). At Month 12, 18% of patients had achieved the combined target for iPTH + Ca x P compared with 2% at baseline. Most patients (65%) received <60 mg/day cinacalcet at Month 12. Vitamin D sterol use remained fairly stable throughout the study. There was a 13% decrease in prescribed sevelamer; use of calcium-based phosphate binders increased by 5.6%. There was no unexpected safety or tolerability concerns.
Conclusion. This analysis of current European clinical practice shows that—consistent with findings from randomized controlled trials and retrospective observational studies—cinacalcet improves attainment of KDOQITM bone metabolism targets in dialysis patients with various stages of SHPT.
Keywords: calcimimetic; cinacalcet; clinical practice; secondary hyperparathyroidism; targets
Received for publication: 8.10.08
Accepted in revised form: 11. 3.09