title: Cinacalcet efficacy in patients with moderately severe primary hyperparathyroidism according to the European Medicine Agency prescription labeling.
abstract: BACKGROUND
  Patients with primary hyperparathyroidism (PHPT) with contraindications to parathyroidectomy (PTx) or persistent PHPT have few non surgical options.
  
  
  OBJECTIVE
  The aim of the study was to investigate the efficacy of cinacalcet in reducing serum calcium in patients with PHPT, for whom PTx would be indicated according to serum calcium levels, but in whom PTx is not clinically appropriate or is contraindicated [European Medicines Agency (EMA) prescription labeling].
  
  
  METHODS
  The study (open-label prospective, conducted in a single tertiary center) included 12 sporadic and 2 multiple endocrine neoplasia type 1 PHPT patients with serum calcium greater than 11.2 mg/dl. Cinacalcet was administered in increasing doses until normal serum calcium was reached or side effects preventing a further increase occurred. Serum calcium, PTH, phosphate, 25OHD, markers of bone turnover, 24h-urinary calcium and areal bone mineral density (BMD) were measured. Safety biochemical indices and adverse events were monitored.
  
  
  RESULTS
  The maintenance cinacalcet dose [median 30 mg twice daily (range 30 daily-60 mg twice daily)] was maintained constant during follow-up (median 12 months). Mean±SE baseline serum calcium was 12.2±0.3 mg/dl. Serum calcium decreased by at least 1 mg/dl in all patients and normalized in 10. Serum calcium at the last observation was 9.9±0.2 mg/dl (p<0.0001 vs baseline). PTH decreased by 17.1% compared to baseline (p=0.13), and never reached a normal value. BMD was unchanged. Adverse events occurred in 6 patients (43%) and required treatment withdrawal in 2.
  
  
  CONCLUSIONS
  Cinacalcet reduced and often normalized serum calcium in PHPT patients who met the EMA labeling.
authors.affiliation: Department of Endocrinology and Metabolism, Section of Endocrinology and Bone Metabolism, University of Pisa, Via Paradisa 2, 56124 Pisa, Italy.
authors.forename: F
authors.initials: F
authors.lastname: Cetani
authors.forename: F
authors.initials: F
authors.lastname: Saponaro
authors.forename: C
authors.initials: C
authors.lastname: Banti
authors.forename: L
authors.initials: L
authors.lastname: Cianferotti
authors.forename: E
authors.initials: E
authors.lastname: Vignali
authors.forename: S
authors.initials: S
authors.lastname: Chiavistelli
authors.forename: G
authors.initials: G
authors.lastname: Viccica
authors.forename: A
authors.initials: A
authors.lastname: Pinchera
authors.forename: C
authors.initials: C
authors.lastname: Marcocci
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D015415:Biomarkers / Q000097:blood; D000069449:Cinacalcet; D000075202:Contraindications; D004348:Drug Labeling; D005062:European Union; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D006934:Hypercalcemia / Q000209:etiology / Q000517:prevention & control*; D049950:Hyperparathyroidism, Primary / Q000097:blood / Q000188:drug therapy* / Q000209:etiology / Q000503:physiopathology; D060046:Maintenance Chemotherapy; D049990:Membrane Transport Modulators / Q000009:adverse effects / Q000627:therapeutic use*; D008875:Middle Aged; D018761:Multiple Endocrine Neoplasia Type 1 / Q000503:physiopathology; D009281:Naphthalenes / Q000009:adverse effects / Q000627:therapeutic use*; D016105:Parathyroidectomy; D017410:Practice Guidelines as Topic; D011446:Prospective Studies; D044169:Receptors, Calcium-Sensing / Q000819:agonists*; D012720:Severity of Illness Index
chemical_list: D015415:Biomarkers; D049990:Membrane Transport Modulators; D009281:Naphthalenes; D044169:Receptors, Calcium-Sensing; D000069449:Cinacalcet