title: The OPTIMA study: assessing a new cinacalcet (Sensipar/Mimpara) treatment algorithm for secondary hyperparathyroidism.
abstract: 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.
authors.affiliation: Nephrology Division, CROFF Policlinico di Milano, Via Della Commenda, 20122 Milano, Italy. pmessa@policlinico.mi.it
authors.forename: Piergiorgio
authors.initials: P
authors.lastname: Messa
authors.forename: Fernando
authors.initials: F
authors.lastname: Macário
authors.forename: Magdi
authors.initials: M
authors.lastname: Yaqoob
authors.forename: Koen
authors.initials: K
authors.lastname: Bouman
authors.forename: Johann
authors.initials: J
authors.lastname: Braun
authors.forename: Beat
authors.initials: B
authors.lastname: von Albertini
authors.forename: Hans
authors.initials: H
authors.lastname: Brink
authors.forename: Francisco
authors.initials: F
authors.lastname: Maduell
authors.forename: Helmut
authors.initials: H
authors.lastname: Graf
authors.forename: João M
authors.initials: JM
authors.lastname: Frazão
authors.forename: Willem Jan
authors.initials: WJ
authors.lastname: Bos
authors.forename: Vicente
authors.initials: V
authors.lastname: Torregrosa
authors.forename: Heikki
authors.initials: H
authors.lastname: Saha
authors.forename: Helmut
authors.initials: H
authors.lastname: Reichel
authors.forename: Martin
authors.initials: M
authors.lastname: Wilkie
authors.forename: Valter J
authors.initials: VJ
authors.lastname: Zani
authors.forename: Bart
authors.initials: B
authors.lastname: Molemans
authors.forename: Dave
authors.initials: D
authors.lastname: Carter
authors.forename: Francesco
authors.initials: F
authors.lastname: Locatelli
mesh_terms: 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
chemical_list: D002614:Chelating Agents; D009281:Naphthalenes; D010281:Parathyroid Hormone; D014807:Vitamin D; D010758:Phosphorus; D002118:Calcium; D000069449:Cinacalcet