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Higher Strength Lanthanum Carbonate Provides Serum Phosphorus Control With a Low Tablet Burden and Is Preferred by Patients and Physicians: A Multicenter Study

Rajnish Mehrotra^*, Kevin J. Martin, Steven Fishbane, Stuart M. Sprague, Steven Zeig^||, Michael Anger^¶; for the Fosrenol Overview Research Evaluation Study for Early Experience (FORESEE) Study Group

^* Division of Nephrology and Hypertension, Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center, Torrance, California; Division of Nephrology, Saint Louis University, Saint Louis, Missouri; Winthrop-University Hospital, Mineola, New York; Division of Nephrology and Hypertension, Northwestern University Feinberg School of Medicine, Chicago, Illinois; ^|| Pines Clinical Research, Inc., Pembroke Pines, Florida; and ^¶ Division of Nephrology, University of Colorado Health Sciences Center, Denver, Colorado

Correspondence: Dr. Rajnish Mehrotra, Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center, Division of Nephrology and Hypertension, 1124 W. Carson Street, Torrance, CA 90502. Phone: 310-222-3891; Fax: 310-782-1837; E-mail: rmehrotra{at}labiomed.org

Background and objectives: Management of hyperphosphatemia, a predictor of mortality in chronic kidney disease, is challenging. Nonadherence to dietary phosphate binders, in part, contributes to uncontrolled serum phosphorus levels. This phase IIIb trial assessed the efficacy of increased dosages (3000 to 4500 mg/d) of reformulated lanthanum carbonate (500-, 750-, and 1000-mg tablets) in nonresponders to dosages of up to 3000 mg/d.

Design, setting, participants, & measurements: This 8-wk study with a 4-mo open-label extension enrolled 513 patients who were undergoing maintenance hemodialysis. Patients who achieved serum phosphorus control at week 4 with 3000 mg/d lanthanum carbonate entered cohort A; nonresponders were randomly assigned to receive 3000, 3750, or 4500 mg/d (cohort B). The primary outcome measure was the control rate for predialysis serum phosphorus levels at the end of week 8, among patients in cohort B.

Results: At the end of week 4, 54% of patients achieved serum phosphorus control at dosages 3000 mg/d administered as one tablet per meal. Among patients who entered cohort B, control rates of 25, 38, and 32% for patients who were randomly assigned to 3000, 3750, or 4500 mg/d lanthanum carbonate, respectively, were achieved, with no increase in adverse events. Patients and physicians reported significantly higher levels of satisfaction with reformulated lanthanum carbonate compared with previous phosphate binders, partly because of reduced tablet burden with higher dosage strengths. Physicians and patients also expressed a preference for lanthanum carbonate over previous medication.

Conclusions: Reformulated lanthanum carbonate is an effective phosphate binder that may reduce daily tablet burden.