Effective in the treatment of native dialysis patients and in patients for whom other commonly used phosphate binders are intolerable or ineffective

Two retrospective data analyses from patients treated in a dialysis center were presented at the National Kidney Foundation (NKF) Spring Clinical Meeting, (March 25-29 in Nashville, TN) by Shire, the makers of FOSRENOL^® (lanthanum carbonate). These data demonstrated that FOSRENOL treatment in conjunction with patient education was shown to be effective in lowering and maintaining serum phosphorus levels in patients with chronic kidney disease (CKD) within the National Kidney Foundationís Kidney Disease Outcomes Quality Initiative (K/DOQI) guidelines of <5.5 mg/dL.^1,2

The first poster, presented by Linda Noto, Western New York Dialysis Center, LLC, Orchard Park, New York, reported on a retrospective study of 16 patients with elevated serum phosphorous levels to determine the efficacy of treatment with FOSRENOL (lanthanum carbonate) in conjunction with patient education, in controlling serum phosphate levels in patients who had not previously been treated with phosphate binders either before starting dialysis (n=5) or as primary treatment after starting dialysis (n=11).¹ These data showed the control of serum phosphorus levels, maintained within the KDOQI guideline of ?5.5 mg/dL, after primary treatment with FOSRENOL in conjunction with patient education was rapid (within 1 month) and sustained (after 6 months) in 81.3% of patients previously untreated with phosphorus binders after starting dialysis.

• Of the 16 patients in the study 88% (n=14) met the guideline 1 month after starting dialysis and 81% (n=13) maintained control after 6 months.¹
• Of the 11 patients who began treatment with FOSRENOL after the start of dialysis 82% (n=9) reached this level within 1 month and maintained control after 6 months.¹
• Patient nutritional status was maintained throughout treatment.¹*

The second poster, also presented by Linda Noto, reported on a retrospective observational study of 17 CKD patients on dialysis for 1 year who were changed to FOSRENOL (lanthanum carbonate) therapy in conjunction with patient education when treatment with other phosphate binders (calcium acetate n=8; sevelamer hydrochloride n=7; or calcium carbonate n=2) became ineffective or intolerable² The findings suggest:

FOSRENOL may be a choice for patients for whom other phosphate binders were ineffective or poorly tolerated.

• Of the 14 patients who were above the K/DOQI guidelines of <5.5 mg/dL before changing therapies:²
• 43% (n=6) were within the guidelines by 1 to 3 months after the change;
• 78% (n=11) were within the guidelines at 10 to 12 months after the change.

The proportion of patients with serum phosphorus levels within K/DOQI guidelines increased from 18% of patients (n=3) before changing to FOSRENOL to 65% of patients (n=11) by 1 year after receiving FOSRENOL treatment.²

Hyperphosphatemia in CKD Stage 5 is predictor of mortality^3,4,5; therefore, managing elevated serum phosphorus levels (hyperphosphatemia), and maintaining serum phosphate levels within the K/DOQI guidelines for dialysis dependent CKD Stage 5 patients is an important goal. In addition, maintaining the nutritional status of patients is critical.

FOSRENOL (lanthanum carbonate) is indicated to reduce serum phosphate in patients with end-stage renal disease.

Important Safety Information

The most common adverse events were gastrointestinal, such as nausea and vomiting, and generally abated over time with continued dosing.
• The most common side effects leading to discontinuation in clinical trials were gastrointestinal events (nausea, vomiting, and diarrhea). Other side effects reported in trials included dialysis graft complications, headache, abdominal pain, and hypotension.
• Although studies were not designed to detect differences in risk of fracture and mortality, there were no differences demonstrated in patients treated with FOSRENOL compared to alternative therapy for up to 3 years.
• The duration of treatment exposure and time of observation in the clinical program were too short to conclude that FOSRENOL does not affect the risk of fracture or mortality beyond 3 years.
• While lanthanum has been shown to accumulate in the GI tract, liver, and bone in animals, the clinical significance in humans is unknown.
• Patients with acute peptic ulcer, ulcerative colitis, Crohnís disease, or bowel obstruction were not included in FOSRENOL clinical studies.
• Caution should be used in patients with these conditions.
• FOSRENOL should not be taken by patients who are nursing or pregnant.
• FOSRENOL should not be taken by patients who are under 18 years of age.
• You are encouraged to report negative side affects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
• For full prescribing information, please visit www.fosrenol.com.

References

1. Noto L. Rapid and Sustained Reduction of Phosphorous Levels with Lanthanum Carbonate Treatment in Phosphorous Binder-NaÔve Patients. Presented at the National Kidney Foundation Spring Clinical Meeting, March 25-29, 2009, Nashville, TN.
2. Noto L. Improved Phosphorous Control in Patients Switched in Lanthanum Carbonate from Other Binders. Presented at the National Kidney Foundation Spring Clinical Meeting, March 25-29, 2009, Nashville, TN.
3. Moe SM, Dr¸eke T, Lameire N, Eknoyan G. Chronic kidney diseaseñmineral-bone disorder: a new paradigm. Adv Chronic Kidney Dis. 2007;14(1):3-12.
4. Block GA, Klassen PA, Lazarus JM, et al. Mineral metabolism, mortality, and morbidity in maintenance hemodialysis. J Am Soc Nephrol. 2004; 15:2208-2218.
5. Danese MD, Belozeroff V, Smirnakis K, Rothman KJ. Consistent control of mineral and bone disorder in incident hemodialysis patients. Clin J Am Soc Nephrol. 2008; 3(5): 1423-1429.