From the FDA Drug Label
The ability of sevelamer hydrochloride to lower serum phosphorus in CKD patients on dialysis was demonstrated in six clinical trials: one double-blind placebo-controlled 2-week study (sevelamer hydrochloride N=24); two open-label uncontrolled 8-week studies (sevelamer hydrochloride N=220) and three active-controlled open-label studies with treatment durations of 8 to 52 weeks (sevelamer hydrochloride N=256). Eighty-four CKD patients on hemodialysis who were hyperphosphatemic (serum phosphorus >6 mg/dL) following a two-week phosphate binder washout period received sevelamer hydrochloride and active-control for eight weeks each in random order. Both treatments significantly decreased mean serum phosphorus by about 2 mg/dL
The best emergent phosphate binder for a patient with severe hyperphosphatemia is sevelamer hydrochloride.
- It has been shown to significantly decrease mean serum phosphorus by about 2 mg/dL in clinical trials 1.
- The average daily dose of sevelamer hydrochloride at the end of treatment was 4.9 g (range of 0 to 12.6 g) in one study and 6.5 g (range of 0.8 to 13 g) in another study 1.
- Sevelamer hydrochloride can be used in patients with severe hyperphosphatemia, but the dose may need to be adjusted based on the patient's response to treatment.
- It is essential to monitor serum phosphorus levels regularly to ensure that the treatment is effective and to make any necessary adjustments to the dose.
From the Research
For severe hyperphosphatemia requiring emergent treatment, sevelamer is the best oral phosphate binder option due to its efficacy in reducing serum phosphate levels and its safety profile, as evidenced by studies such as 2 and 3.
Key Considerations
- Sevelamer has been shown to be effective in reducing serum phosphate levels in patients with chronic kidney disease, with a study published in 2014 2 demonstrating its superiority over calcium-based phosphate binders in terms of reducing the incidence of hypercalcemia.
- Another study published in 2011 3 highlighted the benefits of sevelamer in preventing and treating hyperphosphatemia in chronic renal failure, including its ability to reduce cardiovascular calcification and improve bone disease.
- While other phosphate binders such as lanthanum carbonate and aluminum-based binders are available, sevelamer is preferred due to its non-calcium-based mechanism of action and lack of systemic absorption, which reduces the risk of calcium overload and vascular calcification.
Treatment Approach
- For ongoing management of severe hyperphosphatemia, sevelamer can be initiated at a dose of 800-1600 mg three times daily with meals, with adjustments made as needed to achieve target serum phosphate levels.
- Dietary phosphate restriction (800-1000 mg/day) and adequate dialysis, if applicable, are essential complementary measures to medication therapy.
- Treating the underlying cause of hyperphosphatemia is also crucial in managing the condition effectively.
Supporting Evidence
- A comparative study published in 2014 2 found that sevelamer was superior to calcium-based phosphate binders in reducing serum phosphate levels and preventing hypercalcemia.
- A review published in 2011 3 highlighted the benefits of sevelamer in preventing and treating hyperphosphatemia in chronic renal failure, including its ability to reduce cardiovascular calcification and improve bone disease.
- Another study published in 2012 4 compared the efficacy of sevelamer and nicotinic acid in hemodialysis patients and found that sevelamer was more effective in reducing serum phosphate levels and the calcium-phosphate product.