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Sevelamer Versus Calcium-Based Binders for Treatment of Hyperphosphatemia in CKD: A Meta-Analysis of Randomized
Leena Patel1, Lisa M Bernard1, Grahame J Elder2
1Cornerstone Research Group, Burlington, Ontario, Canada;
Insights
Sevelamer, a non-calcium-based phosphate binder, significantly reduced all-cause mortality in patients with chronic kidney disease (CKD) stages 3-5D compared to calcium-based binders. Further research is needed for CKD patients not on dialysis.
Area of Science:
- Nephrology
- Pharmacology
- Clinical Trials
Background:
- Patients with chronic kidney disease (CKD) stages 3-5, particularly those on dialysis (5D), face elevated mortality risks.
- Hyperphosphatemia is a significant contributor to mortality in CKD patients.
- Oral phosphate binders, including sevelamer and calcium-based binders (CBBs), are crucial for managing serum phosphate levels.
Purpose of the Study:
- To conduct an updated meta-analysis comparing the efficacy and safety of sevelamer (a non-CBB) versus CBBs in CKD stages 3-5D.
- To evaluate patient-level outcomes such as mortality, cardiovascular events, and hospitalizations.
- To assess intermediate and biochemical outcomes, including vascular calcification, bone changes, and serum levels of phosphate, calcium, and parathyroid hormone.
Main Methods:
- Systematic review and meta-analysis of randomized controlled trials.
- Identification of studies through MEDLINE and the Cochrane Central Register of Controlled Trials.
- Inclusion of patient-level data on mortality, cardiovascular events, hospitalizations, adverse effects, and biochemical markers.
Main Results:
- Sevelamer use was associated with a significant reduction in all-cause mortality (RR, 0.54; 95% CI, 0.32 to 0.93).
- No significant difference in cardiovascular mortality was observed.
- Sevelamer led to lower serum cholesterol, LDL-cholesterol, and calcium levels, with a reduced risk of hypercalcemia.
- Serum phosphate levels showed no significant difference between groups, while intact parathyroid hormone was higher with sevelamer.
Conclusions:
- Sevelamer demonstrates a survival benefit in patients with CKD stages 3-5D compared to CBBs.
- The study highlights the need for placebo-controlled trials to clarify the benefits of phosphate binders in CKD patients not on dialysis.
Background And Objectives:
People with CKD stages 3-5 and on dialysis (5D) have dramatically increased mortality, which has been associated with hyperphosphatemia in many studies. Oral phosphate binders are commonly prescribed to lower serum phosphate. We conducted an updated meta-analysis of the noncalcium-based binder (non-CBB) sevelamer versus CBBs in CKD stages 3-5D.
Design, Setting, Participants, & Measurements:
Randomized, controlled trials comparing sevelamer with CBBs were identified through MEDLINE and the Cochrane Central Register of Controlled Trials. Patient-level outcomes included all-cause mortality, cardiovascular events and mortality, hospitalization, and adverse effects. Intermediate outcomes included vascular calcification and bone changes. Biochemical outcomes included serum phosphate, calcium, parathyroid hormone, lipids, and hypercalcemia. We conducted and reported this review according to Cochrane guidelines.
Results:
We included 25 studies to March 31, 2015 with 4770 participants (88% on hemodialysis). Patients receiving sevelamer had lower all-cause mortality (risk ratio [RR], 0.54; 95% confidence interval [95% CI], 0.32 to 0.93), no statistically significant difference in cardiovascular mortality (n=2712; RR, 0.33; 95% CI, 0.07 to 1.64), and an increase in combined gastrointestinal events of borderline statistical significance (n=384; RR, 1.42; 95% CI, 0.97 to 2.08). For biochemical outcomes, patients receiving sevelamer had lower total serum cholesterol (mean difference [MD], -20.2 mg/dl; 95% CI, -25.9 to -14.5 mg/dl), LDL-cholesterol (MD, -21.6 mg/dl; 95% CI, -27.9 to -15.4 mg/dl), and calcium (MD, -0.4 mg/dl; 95% CI, -0.6 to -0.2 mg/dl) and a reduced risk of hypercalcemia (RR, 0.30; 95% CI, 0.19 to 0.48). End of treatment intact parathyroid hormone was significantly higher for sevelamer (MD, 32.9 pg/ml; 95% CI, 0.1 to 65.7 pg/ml). Serum phosphate values showed no significant differences.
Conclusions:
Patients with CKD stages 3-5D using sevelamer have lower all-cause mortality compared with those using CBBs. Because of a lack of placebo-controlled studies, questions remain regarding phosphate binder benefits for patients with CKD stages 3-5 and not on dialysis.
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