The OPTIMA study: assessing a new cinacalcet (Sensipar/Mimpara) treatment algorithm for secondary hyperparathyroidism.
OBJECTIVE
Cinacalcet, a novel calcimimetic, targets the calcium-sensing receptor to lower parathyroid hormone (PTH), calcium, and phosphorus levels in dialysis patients with secondary hyperparathyroidism (SHPT). This study compared the efficacy of a cinacalcet-based regimen with unrestricted conventional care (vitamin D and phosphate binders) for achieving the stringent National Kidney Foundation Kidney Disease Outcomes Quality Initiative (KDOQI) targets for dialysis patients.


METHODS
In this multicenter, open-label study, hemodialysis patients with poorly controlled SHPT were randomized to receive conventional care (n = 184) or a cinacalcet-based regimen (n = 368). Doses of cinacalcet, vitamin D sterols, and phosphate binders were adjusted during a 16-wk dose-optimization phase with the use of algorithms that allowed cinacalcet to be used with adjusted doses of vitamin D. The primary end point was the proportion of patients with mean intact PTH < or =300 pg/ml during a 7-wk efficacy assessment phase.


RESULTS
A higher proportion of patients receiving the cinacalcet-based regimen versus conventional care achieved the targets for PTH (71% versus 22%, respectively; P < 0.001), Ca x P (77% versus 58%, respectively; P < 0.001), calcium (76% versus 33%, respectively; P < 0.001), phosphorus (63% versus 50%, respectively; P = 0.002), and PTH and Ca x P (59% versus 16%, respectively, P < 0.001), and allowed a 22% reduction in vitamin D dosage in patients receiving vitamin D at baseline. Achievement of targets was greatest in patients with less severe disease (intact PTH range, 300 to 500 pg/ml) and the cinacalcet dose required was lower in these patients (median = 30 mg/d).


CONCLUSIONS
Compared with conventional therapy, a cinacalcet-based treatment algorithm increased achievement of KDOQI treatment targets in dialysis patients in whom conventional therapy was no longer effective in controlling this disease.
Messa
Piergiorgio
P
Nephrology Division, CROFF Policlinico di Milano, Via Della Commenda, 20122 Milano, Italy. pmessa@policlinico.mi.it
Macário
Fernando
F
Yaqoob
Magdi
M
Bouman
Koen
K
Braun
Johann
J
von Albertini
Beat
B
Brink
Hans
H
Maduell
Francisco
F
Graf
Helmut
H
Frazão
João M
JM
Bos
Willem Jan
WJ
Torregrosa
Vicente
V
Saha
Heikki
H
Reichel
Helmut
H
Wilkie
Martin
M
Zani
Valter J
VJ
Molemans
Bart
B
Carter
Dave
D
Locatelli
Francesco
F
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000465:Algorithms; D002118:Calcium / Q000097:blood; D002614:Chelating Agents / Q000008:administration & dosage / Q000009:adverse effects; D000069449:Cinacalcet; D005260:Female; D006801:Humans; D006962:Hyperparathyroidism, Secondary / Q000097:blood / Q000188:drug therapy*; D007676:Kidney Failure, Chronic / Q000150:complications*; D008297:Male; D008875:Middle Aged; D009281:Naphthalenes / Q000008:administration & dosage* / Q000009:adverse effects; D010281:Parathyroid Hormone / Q000097:blood; D010758:Phosphorus / Q000097:blood; D016896:Treatment Outcome; D014807:Vitamin D / Q000008:administration & dosage / Q000009:adverse effects
D002614:Chelating Agents; D009281:Naphthalenes; D010281:Parathyroid Hormone; D014807:Vitamin D; D010758:Phosphorus; D002118:Calcium; D000069449:Cinacalcet