Cinacalcet efficacy in patients with moderately severe primary hyperparathyroidism according to the European Medicine Agency prescription labeling View Full Text


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Article Info

DATE

2012-07

AUTHORS

F. Cetani, F. Saponaro, C. Banti, L. Cianferotti, E. Vignali, S. Chiavistelli, G. Viccica, A. Pinchera, C. Marcocci

ABSTRACT

BACKGROUND: Patients with primary hyperparathyroidism (PHPT) with contraindications to parathyroidectomy (PTx) or persistent PHPT have few non surgical options. AIM: 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]. SUBJECTS AND 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. More... »

PAGES

655-660

References to SciGraph publications

  • 2008-06. A patient with MEN1-associated hyperparathyroidism, responsive to cinacalcet in NATURE REVIEWS ENDOCRINOLOGY
  • 2008-07. A patient with MEN1-associated hyperparathyroidism, responsive to cinacalcet in NATURE REVIEWS ENDOCRINOLOGY
  • 2008-10. Cardiovascular aspects of primary hyperparathyroidism in JOURNAL OF ENDOCRINOLOGICAL INVESTIGATION
  • Identifiers

    URI

    http://scigraph.springernature.com/pub.10.3275/7970

    DOI

    http://dx.doi.org/10.3275/7970

    DIMENSIONS

    https://app.dimensions.ai/details/publication/pub.1078458752

    PUBMED

    https://www.ncbi.nlm.nih.gov/pubmed/21971564


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