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Comparison of dietary phosphate absorption after single doses of lanthanum carbonate and sevelamer carbonate in healthy volunteers: a balance study.

Author(s): Martin P, Wang P, Robinson A, Poole L, Dragone J, Smyth M, Pratt R

Affiliation(s): Shire Pharmaceuticals, Wayne, PA 19087-5637, USA. pmartin@shire.com

Publication date & source: 2011-05, Am J Kidney Dis., 57(5):700-6. Epub 2011 Feb 26.

Publication type: Comparative Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't

BACKGROUND: Lanthanum carbonate and sevelamer carbonate are noncalcium phosphate binders used to treat hyperphosphatemia in patients with chronic kidney disease. This is the first study to compare phosphate absorption from a standardized meal ingested with a typical clinical dose of these binders. STUDY DESIGN: Randomized open-label crossover study. SETTINGS &#38; PARTICIPANTS: Healthy volunteers were confined to a clinical research center during 4 study periods. Of 31 volunteers randomly assigned, 19 completed all treatments and 18 were analyzed in the pharmacodynamic set (1 was excluded because of vomiting). INTERVENTION: Participants were assigned in random order to meal alone, meal plus lanthanum carbonate (1 tablet containing 1,000 mg of elemental lanthanum), and meal plus sevelamer carbonate (three 800-mg tablets). The gastrointestinal tract was cleared, the meal was ingested (+/- treatment), and rectal effluent was collected. In a fourth period, volunteers repeated the study procedures while fasting. OUTCOMES: The primary end point, net phosphate absorption, was analyzed using a mixed-effect linear model. MEASUREMENTS: Phosphorus content of effluent and duplicate meal samples were measured using inductively coupled plasma-optical emission spectroscopy. RESULTS: The standard meal contained approximately 375 mg of phosphate, 75% of which was absorbed (net absorption, 281.7 +/- 14.1 mg [adjusted mean +/- standard error]). Lanthanum carbonate decreased net phosphate absorption by 45% (net absorption, 156.0 +/- 14.2 mg) compared with 21% (net absorption, 221.8 +/- 14.1 mg) for sevelamer carbonate (P < 0.001). Lanthanum carbonate bound 135.1 +/- 12.3 mg of phosphate, whereas sevelamer carbonate bound 63.2 +/- 12.3 mg, a 71.9-mg difference (95% CI, 40.0-103.8; P < 0.001). Per tablet, this equates to 135 mg of phosphate bound with lanthanum carbonate versus 21 mg with sevelamer carbonate. LIMITATIONS: A single-dose study. CONCLUSIONS: In healthy volunteers, 1,000 mg of lanthanum carbonate decreased phosphate absorption by 45% compared with a 21% decrease with 2,400 mg of sevelamer carbonate. Copyright (c) 2011 National Kidney Foundation, Inc. Published by Elsevier Inc. All rights reserved.

Page last updated: 2011-12-09

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