Cinacalcet and achievement of the NKF/K-DOQI recommended target values for bone and mineral metabolism in real-world clinical practice--the ECHO observational study.
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 > or =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/DOQI(TM) (KDOQI(TM))] 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.


CONCLUSIONS
This analysis of current European clinical practice shows that-consistent with findings from randomized controlled trials and retrospective observational studies-cinacalcet improves attainment of KDOQI bone metabolism targets in dialysis patients with various stages of SHPT.
Clinique du Landy, Saint Ouen, France. urena.pablo@wanadoo.fr
Pablo
P
Ureña
Stefan H
SH
Jacobson
Emanuel
E
Zitt
Marc
M
Vervloet
Fabio
F
Malberti
Neil
N
Ashman
Sean
S
Leavey
Marianne
M
Rix
Ingrid
I
Os
Heikki
H
Saha
Miroslav
M
Ryba
Veronika
V
Bencova
Ana
A
Baños
Valter
V
Zani
Denis
D
Fouque
D000328:Adult; D000368:Aged; D001842:Bone and Bones / Q000378:metabolism*; D002118:Calcium / Q000097:blood; D000069449:Cinacalcet; D005060:Europe; D005260:Female; D006801:Humans; D006962:Hyperparathyroidism, Secondary / Q000188:drug therapy* / Q000209:etiology / Q000378:metabolism; D007676:Kidney Failure, Chronic / Q000150:complications / Q000188:drug therapy / Q000628:therapy; D008297:Male; D008875:Middle Aged; D008903:Minerals / Q000378:metabolism*; D009281:Naphthalenes / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D010281:Parathyroid Hormone / Q000097:blood; D010758:Phosphorus / Q000097:blood; D006435:Renal Dialysis; D014807:Vitamin D / Q000378:metabolism
D008903:Minerals; D009281:Naphthalenes; D010281:Parathyroid Hormone; D014807:Vitamin D; D010758:Phosphorus; D002118:Calcium; D000069449:Cinacalcet