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

• Published in: Kidney international Vol. 67; no. 2; pp. 760 - 771
• Main Authors: Moe, Sharon M., Chertow, Glenn M., Coburn, Jack W., Quarles, L. Darryl, Goodman, William G., Block, Geoffrey A., DrEke, Tilman B., Cunningham, John, Sherrard, Donald J., Mccary, Laura C., Olson, Kurt A., Turner, Stewart A., Martin, Kevin J.
• Format: Journal Article
• Language: English
• Published: New York, NY Elsevier Inc 01.02.2005; Nature Publishing; Elsevier Limited
• Subjects: Adult; Aged; Biological and medical sciences; Bone and Bones - drug effects; Bone and Bones - metabolism; calcimimetic; Calcium - blood; chronic kidney disease (CKD); cinacalcet HCl; Cinacalcet Hydrochloride; dialysis; Diseases of the osteoarticular system; Double-Blind Method; Female; Humans; Hyperparathyroidism, Secondary - blood; Hyperparathyroidism, Secondary - drug therapy; Male; Medical sciences; Middle Aged; Naphthalenes - adverse effects; Naphthalenes - therapeutic use; Nephrology. Urinary tract diseases; NKF-K/DOQI guidelines; Osteoporosis. Osteomalacia. Paget disease; Parathyroid Hormone - blood; Phosphorus - blood; secondary hyperparathyroidism (HPT); dialysis; cinacalcet HCl; calcimimetic; NKF-K/DOQI guidelines; chronic kidney disease (CKD); secondary hyperparathyroidism (HPT); Endocrinopathy; Kidney disease; Secondary; Nephrology; Urinary system disease; Diseases of the osteoarticular system; Bone disease; Metabolism; Recommendation; Urology; Chronic; Treatment; Parathyroid diseases; Dialysis; Cinacalcet; Hyperparathyroidism
• ISSN: 0085-2538; 1523-1755
• DOI: 10.1111/j.1523-1755.2005.67139.x

Achieving NKF-K/DOQI™ bone metabolism and disease treatment goals with cinacalcet HCl. 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 × P) was investigated in subjects on dialysis with secondary HPT. 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 180mg/day. Achievement of K/DOQI goals was determined for each treatment group overall and for subgroups defined by baseline intact PTH (iPTH) and Ca × P levels. 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 9.5mg/dL (2.10–2.37mmol/L) and serum phosphorus within 3.5 to 5.5mg/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 × P < 55mg2/dL2 (4.44mmol2/L2) and concurrent achievement of Ca × P < 55mg2/dL2 (4.44mmol2/L2) and iPTH ≤300 pg/mL (31.8 pmol/L) (65% vs. 36% and 41% vs. 6%, P < 0.001 for each). In subjects on dialysis with secondary HPT, cinacalcet facilitates achievement of the K/DOQI-recommended targets for PTH, calcium, phosphorus, and Ca × P.