Achieving NKF-K/DOQI™ bone metabolism and disease treatment goals with cinacalcet HCl

Sharon Moe, Glenn M. Chertow, Jack W. Coburn, L. Darryl Quarles, William G. Goodman, Geoffrey A. Block, Tilman B. Drüeke, John Cunningham, Donald J. Sherrard, Laura C. McCary, Kurt A. Olson, Stewart A. Turner, Kevin J. Martin

Research output: Contribution to journalArticle

267 Citations (Scopus)

Abstract

Background. The National Kidney Foundation's Kidney Disease Outcomes Quality Initiative (NKF-K/DOQI™) has established guidelines for treatment of secondary hyperparathyroidism (HPT). The ability of cinacalcet HCl (Sensipar™) treatment to improve achievement of target levels of parathyroid hormone (PTH), calcium, phosphorus, and calcium-phosphorus product (Ca x P) was investigated in subjects on dialysis with secondary HPT. Methods. Data were combined from three placebo-controlled, double-blind, 26-week studies with similar design that randomized 1136 subjects on dialysis to receive traditional therapy plus cinacalcet or placebo. Oral cinacalcet was titrated from 30 to 180 mg/day. Achievement of K/DOQI goals was determined for each treatment group overall and for subgroups defined by baseline intact PTH (iPTH) and Ca x P levels. Results. Cinacalcet-treated subjects were more likely to achieve a mean iPTH ≤300 pg/mL (31.8 pmol/L) than were control subjects on traditional therapy (56% vs. 10%, P < 0.001). Cinacalcet-treated subjects were more likely to achieve concentrations of serum calcium within 8.4 to 9.5 mg/dL (2.10-2.37 mmol/L) and serum phosphorus within 3.5 to 5.5 mg/dL (1.13-1.78mmol/L) than were control subjects (49% vs. 24% and 46% vs. 33%, P < 0.001 for each). Cinacalcet also improved achievement of Ca x P < 55 mg2/dL2 (4.44 mmol2/L2) and concurrent achievement of Ca x P < 55 mg2/dL2 (4.44 mmol2/L2) and iPTH ≤300 pg/mL (31.8 pmol/L) (65% vs. 36% and 41% vs. 6%, P < 0.001 for each). Conclusion. In subjects on dialysis with secondary HPT, cinacalcet facilitates achievement of the K/DOQI-recommended targets for PTH, calcium, phosphorus, and Ca x P.

Original languageEnglish
Pages (from-to)760-771
Number of pages12
JournalKidney International
Volume67
Issue number2
DOIs
StatePublished - Feb 2005

Fingerprint

Bone Diseases
Kidney Diseases
Kidney
Phosphorus
Secondary Hyperparathyroidism
Parathyroid Hormone
Calcium
Dialysis
Therapeutics
Placebos
Aptitude
Cinacalcet Hydrochloride
Serum
Guidelines

Keywords

  • Calcimimetic
  • Chronic kidney disease (CKD)
  • Cinacalcet HCl
  • Dialysis
  • NKF-K/DOQI guidelines
  • Secondary hyperparathyroidism (HPT)

ASJC Scopus subject areas

  • Nephrology

Cite this

Moe, S., Chertow, G. M., Coburn, J. W., Quarles, L. D., Goodman, W. G., Block, G. A., ... Martin, K. J. (2005). Achieving NKF-K/DOQI™ bone metabolism and disease treatment goals with cinacalcet HCl. Kidney International, 67(2), 760-771. https://doi.org/10.1111/j.1523-1755.2005.67139.x

Achieving NKF-K/DOQI™ bone metabolism and disease treatment goals with cinacalcet HCl. / Moe, Sharon; Chertow, Glenn M.; Coburn, Jack W.; Quarles, L. Darryl; Goodman, William G.; Block, Geoffrey A.; Drüeke, Tilman B.; Cunningham, John; Sherrard, Donald J.; McCary, Laura C.; Olson, Kurt A.; Turner, Stewart A.; Martin, Kevin J.

In: Kidney International, Vol. 67, No. 2, 02.2005, p. 760-771.

Research output: Contribution to journalArticle

Moe, S, Chertow, GM, Coburn, JW, Quarles, LD, Goodman, WG, Block, GA, Drüeke, TB, Cunningham, J, Sherrard, DJ, McCary, LC, Olson, KA, Turner, SA & Martin, KJ 2005, 'Achieving NKF-K/DOQI™ bone metabolism and disease treatment goals with cinacalcet HCl', Kidney International, vol. 67, no. 2, pp. 760-771. https://doi.org/10.1111/j.1523-1755.2005.67139.x
Moe, Sharon ; Chertow, Glenn M. ; Coburn, Jack W. ; Quarles, L. Darryl ; Goodman, William G. ; Block, Geoffrey A. ; Drüeke, Tilman B. ; Cunningham, John ; Sherrard, Donald J. ; McCary, Laura C. ; Olson, Kurt A. ; Turner, Stewart A. ; Martin, Kevin J. / Achieving NKF-K/DOQI™ bone metabolism and disease treatment goals with cinacalcet HCl. In: Kidney International. 2005 ; Vol. 67, No. 2. pp. 760-771.
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abstract = "Background. The National Kidney Foundation's Kidney Disease Outcomes Quality Initiative (NKF-K/DOQI™) has established guidelines for treatment of secondary hyperparathyroidism (HPT). The ability of cinacalcet HCl (Sensipar™) treatment to improve achievement of target levels of parathyroid hormone (PTH), calcium, phosphorus, and calcium-phosphorus product (Ca x P) was investigated in subjects on dialysis with secondary HPT. Methods. Data were combined from three placebo-controlled, double-blind, 26-week studies with similar design that randomized 1136 subjects on dialysis to receive traditional therapy plus cinacalcet or placebo. Oral cinacalcet was titrated from 30 to 180 mg/day. Achievement of K/DOQI goals was determined for each treatment group overall and for subgroups defined by baseline intact PTH (iPTH) and Ca x P levels. Results. Cinacalcet-treated subjects were more likely to achieve a mean iPTH ≤300 pg/mL (31.8 pmol/L) than were control subjects on traditional therapy (56{\%} vs. 10{\%}, P < 0.001). Cinacalcet-treated subjects were more likely to achieve concentrations of serum calcium within 8.4 to 9.5 mg/dL (2.10-2.37 mmol/L) and serum phosphorus within 3.5 to 5.5 mg/dL (1.13-1.78mmol/L) than were control subjects (49{\%} vs. 24{\%} and 46{\%} vs. 33{\%}, P < 0.001 for each). Cinacalcet also improved achievement of Ca x P < 55 mg2/dL2 (4.44 mmol2/L2) and concurrent achievement of Ca x P < 55 mg2/dL2 (4.44 mmol2/L2) and iPTH ≤300 pg/mL (31.8 pmol/L) (65{\%} vs. 36{\%} and 41{\%} vs. 6{\%}, P < 0.001 for each). Conclusion. In subjects on dialysis with secondary HPT, cinacalcet facilitates achievement of the K/DOQI-recommended targets for PTH, calcium, phosphorus, and Ca x P.",
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AU - Moe, Sharon

AU - Chertow, Glenn M.

AU - Coburn, Jack W.

AU - Quarles, L. Darryl

AU - Goodman, William G.

AU - Block, Geoffrey A.

AU - Drüeke, Tilman B.

AU - Cunningham, John

AU - Sherrard, Donald J.

AU - McCary, Laura C.

AU - Olson, Kurt A.

AU - Turner, Stewart A.

AU - Martin, Kevin J.

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N2 - Background. The National Kidney Foundation's Kidney Disease Outcomes Quality Initiative (NKF-K/DOQI™) has established guidelines for treatment of secondary hyperparathyroidism (HPT). The ability of cinacalcet HCl (Sensipar™) treatment to improve achievement of target levels of parathyroid hormone (PTH), calcium, phosphorus, and calcium-phosphorus product (Ca x P) was investigated in subjects on dialysis with secondary HPT. Methods. Data were combined from three placebo-controlled, double-blind, 26-week studies with similar design that randomized 1136 subjects on dialysis to receive traditional therapy plus cinacalcet or placebo. Oral cinacalcet was titrated from 30 to 180 mg/day. Achievement of K/DOQI goals was determined for each treatment group overall and for subgroups defined by baseline intact PTH (iPTH) and Ca x P levels. Results. Cinacalcet-treated subjects were more likely to achieve a mean iPTH ≤300 pg/mL (31.8 pmol/L) than were control subjects on traditional therapy (56% vs. 10%, P < 0.001). Cinacalcet-treated subjects were more likely to achieve concentrations of serum calcium within 8.4 to 9.5 mg/dL (2.10-2.37 mmol/L) and serum phosphorus within 3.5 to 5.5 mg/dL (1.13-1.78mmol/L) than were control subjects (49% vs. 24% and 46% vs. 33%, P < 0.001 for each). Cinacalcet also improved achievement of Ca x P < 55 mg2/dL2 (4.44 mmol2/L2) and concurrent achievement of Ca x P < 55 mg2/dL2 (4.44 mmol2/L2) and iPTH ≤300 pg/mL (31.8 pmol/L) (65% vs. 36% and 41% vs. 6%, P < 0.001 for each). Conclusion. In subjects on dialysis with secondary HPT, cinacalcet facilitates achievement of the K/DOQI-recommended targets for PTH, calcium, phosphorus, and Ca x P.

AB - Background. The National Kidney Foundation's Kidney Disease Outcomes Quality Initiative (NKF-K/DOQI™) has established guidelines for treatment of secondary hyperparathyroidism (HPT). The ability of cinacalcet HCl (Sensipar™) treatment to improve achievement of target levels of parathyroid hormone (PTH), calcium, phosphorus, and calcium-phosphorus product (Ca x P) was investigated in subjects on dialysis with secondary HPT. Methods. Data were combined from three placebo-controlled, double-blind, 26-week studies with similar design that randomized 1136 subjects on dialysis to receive traditional therapy plus cinacalcet or placebo. Oral cinacalcet was titrated from 30 to 180 mg/day. Achievement of K/DOQI goals was determined for each treatment group overall and for subgroups defined by baseline intact PTH (iPTH) and Ca x P levels. Results. Cinacalcet-treated subjects were more likely to achieve a mean iPTH ≤300 pg/mL (31.8 pmol/L) than were control subjects on traditional therapy (56% vs. 10%, P < 0.001). Cinacalcet-treated subjects were more likely to achieve concentrations of serum calcium within 8.4 to 9.5 mg/dL (2.10-2.37 mmol/L) and serum phosphorus within 3.5 to 5.5 mg/dL (1.13-1.78mmol/L) than were control subjects (49% vs. 24% and 46% vs. 33%, P < 0.001 for each). Cinacalcet also improved achievement of Ca x P < 55 mg2/dL2 (4.44 mmol2/L2) and concurrent achievement of Ca x P < 55 mg2/dL2 (4.44 mmol2/L2) and iPTH ≤300 pg/mL (31.8 pmol/L) (65% vs. 36% and 41% vs. 6%, P < 0.001 for each). Conclusion. In subjects on dialysis with secondary HPT, cinacalcet facilitates achievement of the K/DOQI-recommended targets for PTH, calcium, phosphorus, and Ca x P.

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KW - Chronic kidney disease (CKD)

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KW - NKF-K/DOQI guidelines

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