Cinacalcet reduces serum calcium concentrations in patients with intractable primary hyperparathyroidism.
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.
Marcocci
Claudio
C
Department of Endocrinology and Metabolism, University of Pisa, Via Paradisa 2, Pisa, Italy. c.marcocci@endoc.med.unipi.it
Chanson
Philippe
P
Shoback
Dolores
D
Bilezikian
John
J
Fernandez-Cruz
Laureano
L
Orgiazzi
Jacques
J
Henzen
Christoph
C
Cheng
Sunfa
S
Sterling
Lulu Ren
LR
Lu
John
J
Peacock
Munro
M
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
D009281:Naphthalenes; D010281:Parathyroid Hormone; D002118:Calcium; D000069449:Cinacalcet