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Cinacalcet HCl and concurrent low-dose vitamin D improves treatment of secondary hyperparathyroidism in dialysis patients compared with vitamin D alone: the ACHIEVE study results.
Clin J Am Soc Nephrol. 2008 Nov; 3(6):1718-25.CJ

Abstract

BACKGROUND AND OBJECTIVES

Patients with chronic kidney disease (CKD) receiving dialysis often develop secondary hyperparathyroidism with disturbed calcium and phosphorus metabolism. The National Kidney Foundation-Kidney Disease Outcomes Quality Initiative (KDOQI) was established to guide treatment practices for these disorders. The ACHIEVE study was designed to test two treatment strategies for achieving KDOQI goals.

DESIGN, SETTING, PARTICIPANTS, MEASUREMENTS

Individuals on hemodialysis treated with vitamin D sterols were enrolled in this 33-week study. Subjects were randomly assigned to treatment with either cinacalcet and low-dose vitamin D (Cinacalcet-D) or flexible vitamin D alone (Flex-D) to achieve KDOQI-recommended bone mineral targets. ACHIEVE included a 6-week screening phase, including vitamin D washout, a 16-week dose-titration phase, and an 11-week assessment phase.

RESULTS

Of 173 subjects enrolled, 83% of Cinacalcet-D and 67% of Flex-D subjects completed the study. A greater proportion of Cinacalcet-D versus Flex-D subjects had a >30% reduction in parathyroid hormone (PTH) (68% versus 36%, P < 0.001) as well as PTH <300 pg/ml (44% versus 23%, P = 0.006). The proportion of subjects simultaneously achieving targets for intact PTH (150-300 pg/ml) and calcium-phosphorus product (Ca x P) (<55 mg2/dl2) was also greater (21% versus 14%), but this was not statistically significant. This was attributable to 19% of Cinacalcet-D subjects with a PTH value below the KDOQI target range.

CONCLUSIONS

Achievement of KDOQI targets was difficult, especially with Flex-D. Maintaining calcium and phosphorus target values precluded the use of vitamin D doses necessary to lower PTH to within the narrow target range and highlighted limitations inherent to the KDOQI treatment algorithm.

Authors+Show Affiliations

Winthrop University Hospital, Department Of Nephrology, Mineola, New York 11501, USA. sfishbane@metrorenal.comNo 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)

Comparative Study
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

18945995

Citation

Fishbane, Steven, et al. "Cinacalcet HCl and Concurrent Low-dose Vitamin D Improves Treatment of Secondary Hyperparathyroidism in Dialysis Patients Compared With Vitamin D Alone: the ACHIEVE Study Results." Clinical Journal of the American Society of Nephrology : CJASN, vol. 3, no. 6, 2008, pp. 1718-25.
Fishbane S, Shapiro WB, Corry DB, et al. Cinacalcet HCl and concurrent low-dose vitamin D improves treatment of secondary hyperparathyroidism in dialysis patients compared with vitamin D alone: the ACHIEVE study results. Clin J Am Soc Nephrol. 2008;3(6):1718-25.
Fishbane, S., Shapiro, W. B., Corry, D. B., Vicks, S. L., Roppolo, M., Rappaport, K., Ling, X., Goodman, W. G., Turner, S., & Charytan, C. (2008). Cinacalcet HCl and concurrent low-dose vitamin D improves treatment of secondary hyperparathyroidism in dialysis patients compared with vitamin D alone: the ACHIEVE study results. Clinical Journal of the American Society of Nephrology : CJASN, 3(6), 1718-25. https://doi.org/10.2215/CJN.01040308
Fishbane S, et al. Cinacalcet HCl and Concurrent Low-dose Vitamin D Improves Treatment of Secondary Hyperparathyroidism in Dialysis Patients Compared With Vitamin D Alone: the ACHIEVE Study Results. Clin J Am Soc Nephrol. 2008;3(6):1718-25. PubMed PMID: 18945995.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Cinacalcet HCl and concurrent low-dose vitamin D improves treatment of secondary hyperparathyroidism in dialysis patients compared with vitamin D alone: the ACHIEVE study results. AU - Fishbane,Steven, AU - Shapiro,Warren B, AU - Corry,Dalila B, AU - Vicks,Steven L, AU - Roppolo,Michael, AU - Rappaport,Kenneth, AU - Ling,Xiang, AU - Goodman,William G, AU - Turner,Stewart, AU - Charytan,Chaim, PY - 2008/10/24/pubmed PY - 2009/1/7/medline PY - 2008/10/24/entrez SP - 1718 EP - 25 JF - Clinical journal of the American Society of Nephrology : CJASN JO - Clin J Am Soc Nephrol VL - 3 IS - 6 N2 - BACKGROUND AND OBJECTIVES: Patients with chronic kidney disease (CKD) receiving dialysis often develop secondary hyperparathyroidism with disturbed calcium and phosphorus metabolism. The National Kidney Foundation-Kidney Disease Outcomes Quality Initiative (KDOQI) was established to guide treatment practices for these disorders. The ACHIEVE study was designed to test two treatment strategies for achieving KDOQI goals. DESIGN, SETTING, PARTICIPANTS, MEASUREMENTS: Individuals on hemodialysis treated with vitamin D sterols were enrolled in this 33-week study. Subjects were randomly assigned to treatment with either cinacalcet and low-dose vitamin D (Cinacalcet-D) or flexible vitamin D alone (Flex-D) to achieve KDOQI-recommended bone mineral targets. ACHIEVE included a 6-week screening phase, including vitamin D washout, a 16-week dose-titration phase, and an 11-week assessment phase. RESULTS: Of 173 subjects enrolled, 83% of Cinacalcet-D and 67% of Flex-D subjects completed the study. A greater proportion of Cinacalcet-D versus Flex-D subjects had a >30% reduction in parathyroid hormone (PTH) (68% versus 36%, P < 0.001) as well as PTH <300 pg/ml (44% versus 23%, P = 0.006). The proportion of subjects simultaneously achieving targets for intact PTH (150-300 pg/ml) and calcium-phosphorus product (Ca x P) (<55 mg2/dl2) was also greater (21% versus 14%), but this was not statistically significant. This was attributable to 19% of Cinacalcet-D subjects with a PTH value below the KDOQI target range. CONCLUSIONS: Achievement of KDOQI targets was difficult, especially with Flex-D. Maintaining calcium and phosphorus target values precluded the use of vitamin D doses necessary to lower PTH to within the narrow target range and highlighted limitations inherent to the KDOQI treatment algorithm. SN - 1555-905X UR - https://www.unboundmedicine.com/medline/citation/18945995/Cinacalcet_HCl_and_concurrent_low_dose_vitamin_D_improves_treatment_of_secondary_hyperparathyroidism_in_dialysis_patients_compared_with_vitamin_D_alone:_the_ACHIEVE_study_results_ L2 - https://cjasn.asnjournals.org/cgi/pmidlookup?view=long&amp;pmid=18945995 DB - PRIME DP - Unbound Medicine ER -