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

摘要: Background: Patients with primary hyperparathyroidism (PHPT) contraindications to parathyroidectomy (PTx) or persistent PHPT have few non surgical options. Aim: The aim of the study was investigate efficacy cinacalcet in reducing serum calcium patients PHPT, for whom PTx would be indicated according levels, but is not clinically appropriate contraindicated [European Medicines Agency (EMA) prescription labeling]. Subjects and methods: (open-label prospective, conducted a single tertiary center) included 12 sporadic 2 multiple endocrine neoplasia type 1 greater than 11.2 mg/dl. Cinacalcet administered increasing doses until normal reached side effects preventing further increase occurred. Serum calcium, PTH, phosphate, 25OHD, markers bone turnover, 24h-urinary areal mineral density (BMD) were measured. Safety biochemical indices adverse events monitored. Results: maintenance dose [median 30 mg twice daily (range daily-60 daily)] maintained constant during follow-up (median months). Mean±SE baseline 12.2±0.3 decreased by at least mg/dl all normalized 10. last observation 9.9±0.2 (p<0.0001 vs baseline). PTH 17.1% compared (p=0.13), never value. BMD unchanged. Adverse occurred 6 (43%) required treatment withdrawal 2. Conclusions: reduced often who met EMA labeling.