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Cinacalcet in the management of primary hyperparathyroidism: post marketing experience of an Italian multicentre group
Author(s) -
Saponaro Federica,
Faggiano Antongiulio,
Grimaldi Franco,
Borretta Giorgio,
Brandi Maria Luisa,
Minisola Salvatore,
Frasoldati Andrea,
Papini Enrico,
Scillitani Alfredo,
Banti Chiara,
Prete Michela Del,
Vescini Fabio,
Gianotti Laura,
Cavalli Loredana,
Romagnoli Elisabetta,
Colao Annamaria,
Cetani Filomena,
Marcocci Claudio
Publication year - 2013
Publication title -
clinical endocrinology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.055
H-Index - 147
eISSN - 1365-2265
pISSN - 0300-0664
DOI - 10.1111/cen.12108
Subject(s) - cinacalcet , primary hyperparathyroidism , medicine , parathyroidectomy , hypercalcaemia , hyperparathyroidism , urology , surgery , parathyroid hormone , secondary hyperparathyroidism , calcium
Summary 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 ). Design Retrospective data collection from 100 patients with sporadic (s PHPT ) and 35 with familial PHPT (f PHPT ) followed in eight Italian centres between October 2008 and March 2011. Measurements Albumin‐adjusted serum calcium, PTH , 25 OHD , 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 s PHPT and 2·75 ± 0·17 nmol/l in f PHPT patients ( P = 0·007). The cinacalcet EMA labelling was met in 53% s PHPT and 26% f PHPT patients. High surgical risk (34%), negative preoperative imaging (19%), control of hypercalcaemia before parathyroidectomy ( PT x) (24%), and refusal of PT x (19%) accounted for cinacalcet prescription in 96% of s PHPT patients. Conversely, initial treatment (34%), persistent/relapsing PHPT after surgery (31%), and refusal of PTx (14%) were the indications in 79% f PHPT patients. Cinacalcet was started at 30 mg/daily in 64% of s PHPT and 91% of f PHPT 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 s PHPT and 80% of f PHPT ) 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 Treatment was withdrawn in six patients because of side effects.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 f PHPT patients. Cinacalcet effectively reduces serum calcium in patients with either s PHPT or f PHPT .