Impact of vitamin D dose on biochemical parameters in patients with secondary hyperparathyroidism receiving cinacalcet.

Abstract

BACKGROUND/AIMS:

The calcimimetic cinacalcet (Mimpara/Sensipar) simultaneously lowers parathyroid hormone (PTH), phosphorus (P) and calcium (Ca) levels in patients with secondary hyperparathyroidism. The OPTIMA study demonstrated that cinacalcet and adjusted doses of vitamin D maximized control of these parameters. This post-hoc analysis of OPTIMA data assessed the impact of reducing or increasing the dose of concomitant vitamin D on PTH, P and Ca in patients receiving cinacalcet.

METHODS:

Dialysis patients with mean baseline intact PTH (iPTH) 300-800 pg/ml (31.8-84.8 pM) received doses of cinacalcet titrated to achieve an iPTH of 150-300 pg/ml (15.9-31.8 pM). The dose of vitamin D could then be decreased to further reduce serum P or Ca, or increased/initiated to further decrease PTH levels if iPTH >300 pg/ml or to increase Ca if Ca <8.0 mg/dl (2.0 mM).

RESULTS:

Vitamin D dose was assessed for 345 patients during a 23-week period. A total of 91 and 129 patients had an increase or decrease in vitamin D dose, respectively. By study end, mean iPTH, P, and Ca were similar in both vitamin D groups, although there were differences in biochemical parameters between groups at the start of the study. There were statistically significant reductions from baseline to study end in iPTH and Ca in both groups (p < 0.001). Although P was significantly reduced by week 23 in the group in which vitamin D dose was decreased (p = 0.007), the reduction in P was less and did not achieve significance in the group in which vitamin D dose was increased (p = 0.71).

CONCLUSIONS:

After initiating cinacalcet, the dose of vitamin D can be adjusted to maximize reductions in PTH, P and Ca; however, vitamin D-induced decreases in PTH need to be balanced with the diminished response in P and Ca.

• Authors: Martin Wilkie, Giuseppe Pontoriero, Fernando Macário, Magdi Yaqoob, Koen Bouman, Johann Braun, Beat von Albertini, Hans Brink, Francisco Maduell, Helmut Graf, João M Frazão, Willem Jan Bos, Vicente Torregrosa, Heikki Saha, Helmut Reichel, Valter J Zani, Dave Carter, Piergiorgio Messa
• Journal: Nephron. Clinical practice (Nephron Clin Pract) Vol. 112 Issue 1 Pg. c41-50 ( 2009) ISSN: 1660-2110 [Electronic] Switzerland
• PMID: 19365139 (Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Copyright 2009 S. Karger AG, Basel.

Chemical References

• Naphthalenes
• Parathyroid Hormone
• Vitamin D
• Phosphorus
• Calcium
• Cinacalcet

Topics

• Adult
• Calcium (blood)
• Cinacalcet
• Dose-Response Relationship, Drug
• Female
• Humans
• Hypercalcemia (drug therapy, etiology)
• Hyperparathyroidism, Secondary (blood, drug therapy, etiology)
• Hyperphosphatemia (drug therapy, etiology)
• Kidney Failure, Chronic (blood, complications, therapy)
• Male
• Naphthalenes (therapeutic use)
• Parathyroid Hormone (blood)
• Phosphorus (blood)
• Renal Dialysis
• Vitamin D (administration & dosage, pharmacology, therapeutic use)