Higher Initial Doses of FOSRENOL Result in More Rapid Control of Mean Serum Phosphorus
By Shire plc
Apr 23, 2006, 19:11
According to data presented today at the National Kidney Foundation's (NKF) 2006 clinical meeting in Chicago, IL, a conversion to the non-calcium phosphate binder FOSRENOL (lanthanum carbonate) from other phosphate binder therapies provides continued mean serum phosphorus control for end-stage renal disease (ESRD) patients with hyperphosphatemia, while significantly reducing their daily tablet burden and the total daily dose of phosphate binder medication.
This naturalistic ("real world"), large-scale phase IV, open-label, multicenter trial (n=2,520), was designed to evaluate efficacy, patient and physician satisfaction, and daily dose and tablet burden compared with previous phosphate binder therapy. In addition to reducing tablet burden, changing to FOSRENOL from other therapies resulted in significant improvements in both patient and physician satisfaction with phosphate binder therapy. Both patients and physicians preferred FOSRENOL (lanthanum carbonate) over sevelamer hydrochloride (HCI) and calcium-based phosphate binders in a naturalistic study.
"Successfully managing hyperphosphatemia is a challenge for most ESRD patients due to the exceedingly restrictive diet they must follow and the high tablet burden associated with traditional phosphate binder therapies," said Nirupama Vemuri, MD, South Florida Nephrology Group, Coral Springs, FL. "By significantly reducing phosphate binder tablet burden, FOSRENOL may help improve patient compliance, as well as clinical outcomes for patients with hyperphosphatemia."
At baseline, 52 percent of physicians expressed overall satisfaction with their phosphate binder therapies compared with 84 percent following 12 weeks of treatment with FOSRENOL. Among patients who completed 12 weeks of treatment (n=1,862), baseline satisfaction was 67 percent, and this increased to 84 percent after 12 weeks of treatment with FOSRENOL.
This study showed approximately a 30 to 40 percent reduction in tablet burden overall, and up to a 56 percent reduction in tablet burden compared with combination therapy. Since early 2006, a new higher dosage formulation of FOSRENOL has been available. The new formulation, which offers a reduced tablet size, may allow an additional 50 percent reduction over the FOSRENOL doses used in the study. Patients may be able to take just one tablet per meal. (Dosing based on three meals per day. Number of meals per day may vary. To achieve certain doses, additional tablets may be required.)
Higher Initial Doses of FOSRENOL More Rapidly Control Mean Serum Phosphorus Additional data being presented at the NKF meeting (an analysis of two previously reported clinical studies) demonstrate that higher initial doses of FOSRENOL can help ESRD patients more rapidly control hyperphosphatemia, without a dose-related increase in adverse events. Patients taking 1,350 mg of FOSRENOL per day achieved phosphorus control after a median treatment duration of 14 days, whereas those taking 2,250 mg/day achieved control in just seven days. (The recommended initial daily dose of FOSRENOL is 750-1,500 mg and the dose should be titrated every two to three weeks until an acceptable serum phosphate level is reached.)
Further, the study found that the doses of FOSRENOL needed to control mean serum phosphorus levels were related to patients' baseline mean serum phosphorus levels, with higher baseline values predicting the need for higher FOSRENOL doses.
"To prevent the serious, long-term complications of hyperphosphatemia, patients must achieve and maintain target mean serum phosphorus levels--a difficult goal for many ESRD patients," said George Porter, MD, FACP, Division of Nephrology and Hypertension, Oregon Health Sciences University. "This study shows that adjusting initial FOSRENOL doses according to pretreatment serum phosphorous levels may help accelerate serum phosphorus control in ESRD patients."
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