A computerized treatment algorithm trial to optimize mineral metabolism in ESRD.
OBJECTIVE
Achievement of mineral targets in patients receiving dialysis remains challenging. This study sought to evaluate outcomes for phosphorus, calcium, and parathyroid hormone when a dialysis population was switched from a predominantly active vitamin D analogue treatment regimen to a computerized algorithm incorporating both cinacalcet and active vitamin D as potential first-line therapies.


METHODS
This longitudinal prospective trial enrolled 92 patients undergoing maintenance hemodialysis. Baseline measures (the average of the 3 months before computerized algorithm implementation) were compared with the proportion of patients achieving the prespecified targets at 6 and 12 months.


RESULTS
After 6 months there was a statistically significant improvement in the percentage of patients achieving the primary and secondary phosphorus targets (primary: phosphorus ≤ 5.5 mg/dl, increase from 41% to 75%, P<0.001; secondary: phosphorus 3.0-4.6 mg/dl, increase from 16% to 38%; P=0.005). These improvements were sustained at 12 months. There was a statistically significant improvement in the percentage of patients achieving all three prespecified secondary endpoints (an increase from 12.8% to 25.6% at 12 months; P=0.04); however, this was mainly driven by improved phosphorus control. The proportion of patients achieving the primary or secondary parathyroid hormone targets did not improve.


CONCLUSIONS
A greater proportion of dialysis patients achieved improved phosphorus but not parathyroid hormone control by switching from a predominantly active vitamin D analogue-based treatment regimen for mineral and bone disorder to a computer-driven algorithm that incorporated cinacalcet and low-dose active vitamin D analogues as first-line therapy.
Department of Medicine, Division of Renal Diseases and Hypertension, University of Colorado, Denver, 80220, USA. david.spiegel@ucdenver.edu
David M
DM
Spiegel
Lesley
L
McPhatter
Ann
A
Allison
Joanne C
JC
Drumheller
Robert
R
Lockridge
D000368:Aged; D000465:Algorithms; D015415:Biomarkers / Q000097:blood; D057966:Calcimimetic Agents / Q000008:administration & dosage*; D002118:Calcium / Q000097:blood; D000069449:Cinacalcet; D057915:Drug Substitution; D004360:Drug Therapy, Computer-Assisted; D005260:Female; D006801:Humans; D007676:Kidney Failure, Chronic / Q000097:blood / Q000150:complications / Q000628:therapy*; D008137:Longitudinal Studies; D008297:Male; D008659:Metabolic Diseases / Q000097:blood / Q000188:drug therapy* / Q000209:etiology; D008875:Middle Aged; D009281:Naphthalenes / Q000008:administration & dosage*; D010281:Parathyroid Hormone / Q000097:blood; D010758:Phosphorus / Q000097:blood; D011446:Prospective Studies; D006435:Renal Dialysis / Q000009:adverse effects; D013997:Time Factors; D016896:Treatment Outcome; D014807:Vitamin D / Q000008:administration & dosage*; D014815:Vitamins / Q000008:administration & dosage*
D015415:Biomarkers; D057966:Calcimimetic Agents; D009281:Naphthalenes; C470125:PTH protein, human; D010281:Parathyroid Hormone; D014815:Vitamins; D014807:Vitamin D; D010758:Phosphorus; D002118:Calcium; D000069449:Cinacalcet