Abstract | OBJECTIVE: DESIGN: This is a randomized, crossover, double-blind study carried out in the University Hospitals. METHODS: Fifteen MEN1 patients with PHPT were randomized to two groups, one administered with 30 mg daily cinacalcet, titrated until calcium normalization, and one with placebo. After 3 months, patients were reassessed and after washout switched to the other treatment. For comparison, 20 sPHPT patients with similar calcium levels were administered with cinacalcet for 3 months. Ionized and total calcium, phosphate, and parathyroid hormone (PTH) were evaluated. CASR Arg990Gly was genotyped on blood DNA by direct sequencing. RESULTS:
Cinacalcet normalized calcium, increased phosphate, and reduced PTH levels in all patients. Cinacalcet dosage required to normalize calcium in MEN1 and sPHPT was not significantly different (45±21 vs 54±25 mg/day). Few mild adverse events, not requiring drug withdrawal, were observed in both the groups. No association between Arg990Gly CASR polymorphism and response to cinacalcet was found. CONCLUSIONS: This short-term prospective study demonstrated that the efficacy profile of cinacalcet in patients with MEN1-related PHPT and in those with sPHPT was similar and was not influenced by the 990 CASR variant. Although long-term safety and efficacy data are required, cinacalcet might be considered a treatment option in MEN1 patients who have contraindications to surgery or persistent PHPT after surgery.
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Authors | Marcello Filopanti, Uberta Verga, Federica Ermetici, Luca Olgiati, Cristina Eller-Vainicher, Sabrina Corbetta, Luca Persani, Paolo Beck-Peccoz, Anna Spada |
Journal | European journal of endocrinology
(Eur J Endocrinol)
Vol. 167
Issue 2
Pg. 157-64
(Aug 2012)
ISSN: 1479-683X [Electronic] England |
PMID | 22577108
(Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Calcimimetic Agents
- Naphthalenes
- Receptors, Calcium-Sensing
- Arginine
- Glycine
- Cinacalcet
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Topics |
- Adenoma
(complications, diagnosis, drug therapy, genetics)
- Adult
- Amino Acid Substitution
(genetics, physiology)
- Arginine
(genetics)
- Calcimimetic Agents
(therapeutic use)
- Cinacalcet
- Cross-Over Studies
- Double-Blind Method
- Female
- Glycine
(genetics)
- Humans
- Hyperparathyroidism, Primary
(diagnosis, drug therapy, etiology, genetics)
- Male
- Middle Aged
- Multiple Endocrine Neoplasia Type 1
(complications, diagnosis, drug therapy, genetics)
- Naphthalenes
(therapeutic use)
- Parathyroid Neoplasms
(complications, diagnosis, drug therapy, genetics)
- Polymorphism, Single Nucleotide
(physiology)
- Prognosis
- Receptors, Calcium-Sensing
(genetics)
- Treatment Outcome
- Young Adult
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