title: Efficacy of cinacalcet with low-dose vitamin D in incident haemodialysis subjects with secondary hyperparathyroidism.
abstract: BACKGROUND
  Treatment with cinacalcet improves the control of secondary hyperparathyroidism (SHPT) and the achievement of calcium and phosphorus targets. Most data come from subjects receiving cinacalcet after several years of dialysis treatment. We therefore compared the efficacy of treatment with cinacalcet and low doses of active vitamin D to flexible doses of active vitamin D alone for the management of SHPT in patients recently initiating haemodialysis.
  
  
  METHODS
  This open-label trial randomized subjects (n = 309) with parathyroid hormone (PTH) >300 pg/mL on dialysis for 3-12 months to either cinacalcet with low-dose active vitamin D, if prescribed (cinacalcet); or usual care without cinacalcet (control). Randomized subjects were stratified by PTH at screening (300-450, >450-600, >600 pg/mL) and by the use of active vitamin D at enrolment. Treatment duration was 12 months, with primary efficacy endpoint (mean PTH reduction ≥ 30% from baseline) assessed at 6 months.
  
  
  RESULTS
  The mean [standard deviation (SD)] haemodialysis vintage at enrolment was 7.2 (2.7) months; 53% of subjects were not receiving active vitamin D at enrolment. There was a significant difference in the achievement of the primary endpoint (≥ 30% PTH reduction at 6 months) between cinacalcet-treated subjects and controls in both the entire cohort (63 versus 38%; n = 304; P < 0.0001) and the subgroup of subjects not receiving active vitamin D at enrolment (70 versus 44%; n = 161; P < 0.01). Hypocalcaemia and gastrointestinal adverse events were more commonly observed in cinacalcet-treated subjects.
  
  
  CONCLUSIONS
  These results indicate that cinacalcet with low-dose active vitamin D, if prescribed, provides a more effective treatment approach than usual care without cinacalcet for SHPT in incident haemodialysis patients, even in relatively treatment-naive patients.
authors: Clinique Du Landy, Saint-Ouen, France. urena.pablo@wanadoo.fr
authors: Pablo
authors: P
authors: Ureña-Torres
authors: Ian
authors: I
authors: Bridges
authors: Cynthia
authors: C
authors: Christiano
authors: Serge H
authors: SH
authors: Cournoyer
authors: Kerry
authors: K
authors: Cooper
authors: Mourad
authors: M
authors: Farouk
authors: Nelson P
authors: NP
authors: Kopyt
authors: Mariano
authors: M
authors: Rodriguez
authors: Daniel
authors: D
authors: Zehnder
authors: Adrian
authors: A
authors: Covic
mesh_terms: D000328:Adult; D000368:Aged; D002118:Calcium / Q000097:blood; D016022:Case-Control Studies; D000069449:Cinacalcet; D015331:Cohort Studies; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D006962:Hyperparathyroidism, Secondary / Q000150:complications / Q000188:drug therapy*; D007390:International Agencies; D008297:Male; D008875:Middle Aged; D009281:Naphthalenes / Q000627:therapeutic use*; D010281:Parathyroid Hormone / Q000097:blood; D010758:Phosphorus / Q000097:blood; D011379:Prognosis; D006435:Renal Dialysis; D051436:Renal Insufficiency, Chronic / Q000150:complications / Q000188:drug therapy*; D014807:Vitamin D / Q000627:therapeutic use*; D014815:Vitamins / Q000627:therapeutic use*
chemical_list: D009281:Naphthalenes; D010281:Parathyroid Hormone; D014815:Vitamins; D014807:Vitamin D; D010758:Phosphorus; D002118:Calcium; D000069449:Cinacalcet
keywords: cinacalcet; incident dialysis; secondary hyperparathyroidism; vitamin D