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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.
Nephrol Dial Transplant. 2009 Sep; 24(9):2852-9.ND

Abstract

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.

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 KDOQI bone metabolism targets in dialysis patients with various stages of SHPT.

Authors+Show Affiliations

Clinique du Landy, Saint Ouen, France. urena.pablo@wanadoo.frNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

19369690

Citation

Ureña, Pablo, et al. "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." Nephrology, Dialysis, Transplantation : Official Publication of the European Dialysis and Transplant Association - European Renal Association, vol. 24, no. 9, 2009, pp. 2852-9.
Ureña P, Jacobson SH, Zitt E, et al. 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. Nephrol Dial Transplant. 2009;24(9):2852-9.
Ureña, P., Jacobson, S. H., Zitt, E., Vervloet, M., Malberti, F., Ashman, N., Leavey, S., Rix, M., Os, I., Saha, H., Ryba, M., Bencova, V., Baños, A., Zani, V., & Fouque, D. (2009). 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. Nephrology, Dialysis, Transplantation : Official Publication of the European Dialysis and Transplant Association - European Renal Association, 24(9), 2852-9. https://doi.org/10.1093/ndt/gfp144
Ureña P, et al. 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. Nephrol Dial Transplant. 2009;24(9):2852-9. PubMed PMID: 19369690.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Ureña,Pablo, AU - Jacobson,Stefan H, AU - Zitt,Emanuel, AU - Vervloet,Marc, AU - Malberti,Fabio, AU - Ashman,Neil, AU - Leavey,Sean, AU - Rix,Marianne, AU - Os,Ingrid, AU - Saha,Heikki, AU - Ryba,Miroslav, AU - Bencova,Veronika, AU - Baños,Ana, AU - Zani,Valter, AU - Fouque,Denis, Y1 - 2009/04/15/ PY - 2009/4/17/entrez PY - 2009/4/17/pubmed PY - 2009/12/16/medline SP - 2852 EP - 9 JF - Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association JO - Nephrol. Dial. Transplant. VL - 24 IS - 9 N2 - 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. 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 KDOQI bone metabolism targets in dialysis patients with various stages of SHPT. SN - 1460-2385 UR - https://www.unboundmedicine.com/medline/citation/19369690/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_ L2 - https://academic.oup.com/ndt/article-lookup/doi/10.1093/ndt/gfp144 DB - PRIME DP - Unbound Medicine ER -