TY - JOUR
T1 - Cinacalcet use patterns and effect on laboratory values and other medications in a large dialysis organization, 2004 through 2006
AU - St. Peter, Wendy L.
AU - Li, Qi
AU - Liu, Jiannong
AU - Persky, Martha
AU - Nieman, Kimberly
AU - Arko, Cheryl
AU - Block, Geoffrey A.
PY - 2009/2/1
Y1 - 2009/2/1
N2 - Background and objectives: Cinacalcet was introduced in mid-2004 to treat secondary hyperparathyroidism in dialysis patients. We aimed to characterize adult patients who received cinacalcet prescriptions and to determine (1) dosage titration and effects on laboratory values, active intravenous vitamin D use, and phosphate binder prescriptions and (2) percentage who achieved National Kidney Foundation Kidney Disease Outcomes Quality Initiative targets for serum parathyroid hormone, calcium, and phosphorus and experienced biochemical adverse effects. Design, setting, participants, & measurements: This observational study evaluated 45,487 prevalent patients from a dialysis organization database linked with the Centers for Medicare and Medicaid Services End-Stage Renal Disease database. Patient characteristics, laboratory values (albumin, parathyroid hormone, calcium, phosphorus), intravenous vitamin D, and oral medication (cinacalcet, phosphate binders) prescriptions were evaluated for cinacalcet patients. Results: By June 2006, almost 32% of patients had received cinacalcet prescriptions. Mean baseline corrected calcium was 9.8 mg/dl and phosphorus was 6.3 mg/dl, and median parathyroid hormone was 577 pg/ml, versus 9.5 mg/dl, 5.3 mg/dl, and 215 pg/ml, respectively, for noncinacalcet patients. Patients with cinacalcet prescriptions for ≥6 mo had corrected calcium reduced by 4.2%, phosphorus by 7.0%, and parathyroid hormone by 29.9% by 12 mo. More cinacalcet patients attained Kidney Disease Outcomes Quality Initiative targets with less hyperparathyroidism, hypercalcemia, and hyperphosphatemia but more hypoparathyroidism and hypocalcemia. Over 12 mo, vitamin D use and use consistency increased, phosphate binder dosages increased, and mean cinacalcet daily dosage reached 55 mg. Conclusions: Patients with cinacalcet prescriptions exhibited more severe hyperparathyroidism and hyperphosphatemia than noncinacalcet patients. Positive effects were less dramatic than in Phase III clinical trials, possibly as a result of modest, slow dosage titration.
AB - Background and objectives: Cinacalcet was introduced in mid-2004 to treat secondary hyperparathyroidism in dialysis patients. We aimed to characterize adult patients who received cinacalcet prescriptions and to determine (1) dosage titration and effects on laboratory values, active intravenous vitamin D use, and phosphate binder prescriptions and (2) percentage who achieved National Kidney Foundation Kidney Disease Outcomes Quality Initiative targets for serum parathyroid hormone, calcium, and phosphorus and experienced biochemical adverse effects. Design, setting, participants, & measurements: This observational study evaluated 45,487 prevalent patients from a dialysis organization database linked with the Centers for Medicare and Medicaid Services End-Stage Renal Disease database. Patient characteristics, laboratory values (albumin, parathyroid hormone, calcium, phosphorus), intravenous vitamin D, and oral medication (cinacalcet, phosphate binders) prescriptions were evaluated for cinacalcet patients. Results: By June 2006, almost 32% of patients had received cinacalcet prescriptions. Mean baseline corrected calcium was 9.8 mg/dl and phosphorus was 6.3 mg/dl, and median parathyroid hormone was 577 pg/ml, versus 9.5 mg/dl, 5.3 mg/dl, and 215 pg/ml, respectively, for noncinacalcet patients. Patients with cinacalcet prescriptions for ≥6 mo had corrected calcium reduced by 4.2%, phosphorus by 7.0%, and parathyroid hormone by 29.9% by 12 mo. More cinacalcet patients attained Kidney Disease Outcomes Quality Initiative targets with less hyperparathyroidism, hypercalcemia, and hyperphosphatemia but more hypoparathyroidism and hypocalcemia. Over 12 mo, vitamin D use and use consistency increased, phosphate binder dosages increased, and mean cinacalcet daily dosage reached 55 mg. Conclusions: Patients with cinacalcet prescriptions exhibited more severe hyperparathyroidism and hyperphosphatemia than noncinacalcet patients. Positive effects were less dramatic than in Phase III clinical trials, possibly as a result of modest, slow dosage titration.
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U2 - 10.2215/CJN.05241008
DO - 10.2215/CJN.05241008
M3 - Article
C2 - 19129318
AN - SCOPUS:66849128215
SN - 1555-9041
VL - 4
SP - 354
EP - 360
JO - Clinical Journal of the American Society of Nephrology
JF - Clinical Journal of the American Society of Nephrology
IS - 2
ER -