title: Cinacalcet in the management of primary hyperparathyroidism: post marketing experience of an Italian multicentre group.
abstract: OBJECTIVE
  To report the Italian experience on cinacalcet use following its approval by the European Medical Agency (EMA) to control hypercalcaemia in patients with primary hyperparathyroidism (PHPT).
  
  
  METHODS
  Retrospective data collection from 100 patients with sporadic (sPHPT) and 35 with familial PHPT (fPHPT) followed in eight Italian centres between October 2008 and March 2011.
  
  
  METHODS
  Albumin-adjusted serum calcium, PTH, 25OHD, daily cinacalcet dose and adverse events were recorded during the follow-up (1-46 months).
  
  
  RESULTS
  Baseline serum calcium was 2·90 ± 0·27 nmol/l in sPHPT and 2·75 ± 0·17 nmol/l in fPHPT patients (P = 0·007). The cinacalcet EMA labelling was met in 53% sPHPT and 26% fPHPT patients. High surgical risk (34%), negative preoperative imaging (19%), control of hypercalcaemia before parathyroidectomy (PTx) (24%), and refusal of PTx (19%) accounted for cinacalcet prescription in 96% of sPHPT patients. Conversely, initial treatment (34%), persistent/relapsing PHPT after surgery (31%), and refusal of PTx (14%) were the indications in 79% fPHPT patients. Cinacalcet was started at 30 mg/daily in 64% of sPHPT and 91% of fPHPT and increased until normocalcaemia was reached or side effects occurred. The final daily dose ranged between 15 and 120 mg. The majority of patients (65% of sPHPT and 80% of fPHPT) become normocalcaemic. Treatment was withdrawn in six patients because of side effects.
  
  
  CONCLUSIONS
  There is a wide heterogeneity in the prescription of cinacalcet in PHPT patients in Italy and the EMA labelling is not always followed, particularly in fPHPT patients. Cinacalcet effectively reduces serum calcium in patients with either sPHPT or fPHPT.
authors.affiliation: Dipartimento di Endocrinologia e Metabolismo, Università di Pisa, Pisa, Italy.
authors.forename: Federica
authors.initials: F
authors.lastname: Saponaro
authors.forename: Antongiulio
authors.initials: A
authors.lastname: Faggiano
authors.forename: Franco
authors.initials: F
authors.lastname: Grimaldi
authors.forename: Giorgio
authors.initials: G
authors.lastname: Borretta
authors.forename: Maria Luisa
authors.initials: ML
authors.lastname: Brandi
authors.forename: Salvatore
authors.initials: S
authors.lastname: Minisola
authors.forename: Andrea
authors.initials: A
authors.lastname: Frasoldati
authors.forename: Enrico
authors.initials: E
authors.lastname: Papini
authors.forename: Alfredo
authors.initials: A
authors.lastname: Scillitani
authors.forename: Chiara
authors.initials: C
authors.lastname: Banti
authors.forename: Michela
authors.initials: M
authors.lastname: Del Prete
authors.forename: Fabio
authors.initials: F
authors.lastname: Vescini
authors.forename: Laura
authors.initials: L
authors.lastname: Gianotti
authors.forename: Loredana
authors.initials: L
authors.lastname: Cavalli
authors.forename: Elisabetta
authors.initials: E
authors.lastname: Romagnoli
authors.forename: Annamaria
authors.initials: A
authors.lastname: Colao
authors.forename: Filomena
authors.initials: F
authors.lastname: Cetani
authors.forename: Claudio
authors.initials: C
authors.lastname: Marcocci
mesh_terms: D000368:Aged; D002118:Calcium / Q000097:blood; D000069449:Cinacalcet; D004305:Dose-Response Relationship, Drug; D005260:Female; D005500:Follow-Up Studies; D005767:Gastrointestinal Diseases / Q000139:chemically induced; D006801:Humans; D049950:Hyperparathyroidism, Primary / Q000097:blood / Q000188:drug therapy*; D006996:Hypocalcemia / Q000139:chemically induced; D007558:Italy; D008297:Male; D008875:Middle Aged; D009281:Naphthalenes / Q000009:adverse effects / Q000627:therapeutic use*; D016105:Parathyroidectomy; D011358:Product Surveillance, Postmarketing; D012189:Retrospective Studies; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D009281:Naphthalenes; D002118:Calcium; D000069449:Cinacalcet