The FOSRENOL^®
Community Bulletin Program

A Program For Your Patients to Help Make the Lifestyle Changes of CKD Stage 5 Part of Their Daily Routine

Preference

Physicians And Patients Prefer FOSRENOL^®

After 4 weeks, physicians overwhelmingly preferred FOSRENOL^® over previous therapies including sevelamer HCl and calcium acetate^{†,‡,§,||,1}

Physicians preferred FOSRENOL® by more than 11 to 1

Patients preferred FOSRENOL® by more than 4 to 1

Physicians and patients reported significantly higher satisfaction with calcium-free FOSRENOL^®

After 24 weeks of therapy, FOSRENOL^® provided significantly greater satisfaction (P<.0001) vs other previous therapies including sevelamer HCl and calcium acetate (physicians: 88% vs 65%; 82% vs 61%, respectively)^†,‡,¶,1

FOSRENOL^® is indicated to reduce serum phosphate in patients with end-stage renal disease.

* Maintenance of reduction was observed for up to 3 years in patients treated with FOSRENOL^®.

† These data reflect an analysis of patient and physician preference and satisfaction during a 24-week, extended, dose-ranging, Phase IIIb, multicenter, parallel-group study assessing treatment with lanthanum carbonate. Physician and patient preference was assessed at Week 4 and physician and patient satisfaction was assessed at Weeks 4, 8, and 24.

‡ 43.5% of patients were previously taking sevelamer HCl; 31.5% of patients were previously taking calcium acetate.

§ Preference is based on responses to a questionnaire that asked whether physicians and patients preferred the "new medication," "previous medication," or had "equal preference."

|| 21% of patients and 27% of physicians had equal preference.

¶ Satisfaction was assessed via the 6-point Likert scale questionnaire. Physician (n=215) and patient (n=211) satisfaction is based on responses from those who responded with "strongly agree" or "agree."

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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, Crohn's 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

Reference

Mehotra R, on behalf of the SPD405-312 Lanthanum Study Group. Preference and satisfaction with reformulated higher dosage strength lanthanum carbonate. Poster presented at: the 39^th Annual Meeting of the American Society of Nephrology: November 14-19, 2006; San Diego, Calif.

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FOS1726 1/15/2008

The FOSRENOL® Community Bulletin Program