Cinacalcet use patterns and effect on laboratory values and other medications in a large dialysis organization, 2004 through 2006.
OBJECTIVE
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.


METHODS
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 > or =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.
St Peter
Wendy L
WL
Chronic Disease Research Group, Minneapolis Medical Research Foundation, 914 South 8th Street, Suite S-406, Minneapolis, MN 55404, USA. wstpeter@cdrg.org
Li
Qi
Q
Liu
Jiannong
J
Persky
Martha
M
Nieman
Kimberly
K
Arko
Cheryl
C
Block
Geoffrey A
GA
D000293:Adolescent; D000328:Adult; D015415:Biomarkers / Q000097:blood*; D002118:Calcium / Q000097:blood; D014487:Centers for Medicare and Medicaid Services, U.S.; D000069449:Cinacalcet; D019992:Databases as Topic; D011307:Drug Prescriptions; D004359:Drug Therapy, Combination; D004363:Drug Utilization; D017723:Drug Utilization Review; D005260:Female; D006801:Humans; D006962:Hyperparathyroidism, Secondary / Q000097:blood / Q000188:drug therapy* / Q000209:etiology; D007676:Kidney Failure, Chronic / Q000150:complications / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D009281:Naphthalenes / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D010043:Outcome and Process Assessment, Health Care / Q000706:statistics & numerical data; D010281:Parathyroid Hormone / Q000097:blood; D010758:Phosphorus / Q000097:blood; D017410:Practice Guidelines as Topic; D010818:Practice Patterns, Physicians' / Q000639:trends*; D006435:Renal Dialysis / Q000009:adverse effects / Q000706:statistics & numerical data; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States; D014807:Vitamin D / Q000627:therapeutic use; D055815:Young Adult
D015415:Biomarkers; D009281:Naphthalenes; D010281:Parathyroid Hormone; D014807:Vitamin D; D010758:Phosphorus; D002118:Calcium; D000069449:Cinacalcet