title: Cinacalcet reduces serum calcium concentrations in patients with intractable primary hyperparathyroidism.
abstract: BACKGROUND
  Patients with persistent primary hyperparathyroidism (PHPT) after parathyroidectomy or with contraindications to parathyroidectomy often require chronic treatment for hypercalcemia.
  
  
  OBJECTIVE
  The objective of the study was to assess the ability of the calcimimetic, cinacalcet, to reduce serum calcium in patients with intractable PHPT.
  
  
  METHODS
  This was an open-label, single-arm study comprising a titration phase of variable duration (2-16 wk) and a maintenance phase of up to 136 wk.
  
  
  METHODS
  The study was conducted at 23 centers in Europe, the United States, and Canada.
  
  
  METHODS
  The study included 17 patients with intractable PHPT and serum calcium greater than 12.5 mg/dl (3.1 mmol/liter).
  
  
  METHODS
  During the titration phase, cinacalcet dosages were titrated every 2 wk (30 mg twice daily to 90 mg four times daily) for 16 wk until serum calcium was 10 mg/dl or less (2.5 mmol/liter). If serum calcium increased during the maintenance phase, additional increases in the cinacalcet dose were permitted.
  
  
  METHODS
  The primary end point was the proportion of patients experiencing a reduction in serum calcium of 1 mg/dl or greater (0.25 mmol/liter) at the end of the titration phase.
  
  
  RESULTS
  Mean +/- sd baseline serum calcium was 12.7 +/- 0.8 mg/dl (3.2 +/- 0.2 mmol/liter). At the end of titration, a 1 mg/dl or greater reduction in serum calcium was achieved in 15 patients (88%). Fifteen patients (88%) experienced treatment-related adverse events, none of which were serious. The most common adverse events were nausea, vomiting, and paresthesias.
  
  
  CONCLUSIONS
  In patients with intractable PHPT, cinacalcet reduces serum calcium, is generally well tolerated, and has the potential to fulfill an unmet medical need.
authors.affiliation: Department of Endocrinology and Metabolism, University of Pisa, Via Paradisa 2, Pisa, Italy. c.marcocci@endoc.med.unipi.it
authors.forename: Claudio
authors.initials: C
authors.lastname: Marcocci
authors.forename: Philippe
authors.initials: P
authors.lastname: Chanson
authors.forename: Dolores
authors.initials: D
authors.lastname: Shoback
authors.forename: John
authors.initials: J
authors.lastname: Bilezikian
authors.forename: Laureano
authors.initials: L
authors.lastname: Fernandez-Cruz
authors.forename: Jacques
authors.initials: J
authors.lastname: Orgiazzi
authors.forename: Christoph
authors.initials: C
authors.lastname: Henzen
authors.forename: Sunfa
authors.initials: S
authors.lastname: Cheng
authors.forename: Lulu Ren
authors.initials: LR
authors.lastname: Sterling
authors.forename: John
authors.initials: J
authors.lastname: Lu
authors.forename: Munro
authors.initials: M
authors.lastname: Peacock
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D002118:Calcium / Q000097:blood*; D000069449:Cinacalcet; D005260:Female; D006304:Health Status; D006801:Humans; D049950:Hyperparathyroidism, Primary / Q000097:blood / Q000188:drug therapy* / Q000523:psychology; D008297:Male; D008875:Middle Aged; D009281:Naphthalenes / Q000009:adverse effects / Q000627:therapeutic use*; D010281:Parathyroid Hormone / Q000097:blood; D011788:Quality of Life
chemical_list: D009281:Naphthalenes; D010281:Parathyroid Hormone; D002118:Calcium; D000069449:Cinacalcet