The calcimimetic AMG 073 reduces parathyroid hormone and calcium x phosphorus in secondary hyperparathyroidism.

Abstract

BACKGROUND:

A need exists for a therapy that lowers parathyroid hormone (PTH) without increasing calcium x phosphorus in patients with secondary hyperparathyroidism. The calcimimetic AMG 073 increases the sensitivity of the parathyroid calcium-sensing receptor to extracellular calcium, thereby reducing PTH secretion. Consequently, AMG 073 may provide a novel therapy for secondary hyperparathyroidism.

METHODS:

Seventy-eight hemodialysis patients with secondary hyperparathyroidism were enrolled into this 18-week, double-blind, randomized, placebo-controlled, dose titration study. Daily oral AMG 073 doses were administered to determine the effect on PTH, serum calcium, phosphorus, and calcium x phosphorus.

RESULTS:

The mean baseline PTH was similar in patients administered AMG 073 or placebo (632 +/- 280.1 pg/mL vs. 637 +/- 455.9 pg/mL, respectively). PTH decreased by 26.0% in the AMG 073-treated group, compared with an increase of 22.0% in the placebo group (P < 0.001). A greater proportion in the AMG 073 group (38%) had a decrease in PTH >or=30%, compared with the placebo group (8%) (P = 0.001). Decreases in PTH were independent of baseline vitamin D usage. Patients receiving AMG 073 had an 11.9% decrease in calcium x phosphorus compared with a 10.9% increase in the placebo group (P < 0.001). Use of vitamin D sterols, as well as both calcium and noncalcium-containing phosphate binders. were similar between treatment groups. Administration of AMG 073 was safe and well tolerated in this 18-week study.

CONCLUSIONS:

The calcimimetic AMG 073 decreases both PTH and calcium x phosphorus levels in hemodialysis patients with secondary hyperparathyroidism.

• Authors: Jill S Lindberg, Sharon M Moe, William G Goodman, Jack W Coburn, Stuart M Sprague, Wei Liu, Peter W Blaisdell, Robert M Brenner, Stewart A Turner, Kevin J Martin
• Journal: Kidney international (Kidney Int) Vol. 63 Issue 1 Pg. 248-54 (Jan 2003) ISSN: 0085-2538 [Print] United States
• PMID: 12472790 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Calcium Channel Agonists
• Naphthalenes
• Parathyroid Hormone
• Phosphorus
• Calcitriol
• Calcium
• Cinacalcet

Topics

• Adult
• Aged
• Calcitriol (administration & dosage)
• Calcium (blood)
• Calcium Channel Agonists (administration & dosage)
• Cinacalcet
• Female
• Humans
• Hyperparathyroidism, Secondary (blood, drug therapy)
• Kidney Failure, Chronic (complications, therapy)
• Male
• Middle Aged
• Naphthalenes (administration & dosage, adverse effects)
• Parathyroid Hormone (blood)
• Phosphorus (blood)
• Renal Dialysis
• Titrimetry