Sevelamer Carbonate

Sevelamer carbonate is a non-absorbed phosphate binding crosslinked polymer, with the same polymeric structure as sevelamer hydrochloride, in which carbonate replaces chloride as the counterion.

Pharmacodynamic Effects of Sucroferric Oxyhydroxide and Sevelamer Carbonate on Vitamin D Receptor Agonist Bioactivity in Dialysis Patients.[Pubmed:27434393]

Am J Nephrol. 2016;44(2):104-12.

BACKGROUND: Many patients with chronic kidney disease are prescribed vitamin D receptor agonists (VDRAs) for the management of secondary hyperparathyroidism. Oral phosphate binders may interact with, and potentially reduce the therapeutic activity of, oral VDRAs. This post hoc analysis of a Phase 3 study evaluated the pharmacodynamic effects of the iron-based phosphate binder sucroferric oxyhydroxide (SFOH) and sevelamer (SEV) carbonate on VDRA activity in dialysis patients. METHODS: One thousand and fifty nine patients were randomized to SFOH 1.0-3.0 g/day (n = 710) or SEV 2.4-14.4 g/day (n = 349) for up to 52 weeks. Potential interactions of SFOH and SEV with VDRAs were assessed using serum intact parathyroid hormone (iPTH) concentrations as a pharmacodynamic biomarker. Three populations of SFOH- and SEV-treated patients were analyzed: Population 1 (n = 187), patients taking concomitant stable doses of oral VDRAs only; Population 2 (n = 250), patients taking no concomitant VDRAs; Population 3 (n = 68), patients taking concomitant stable doses of intravenous paricalcitol only. Populations were compared using a mixed-effects model to obtain the least squares mean change in iPTH from baseline to Week 52. Differences between treatment groups were also compared. RESULTS: In Population 1, iPTH decreased from baseline to Week 52 in the SFOH group (-25.3 pg/ml) but increased in the SEV group (89.8 pg/ml) (p = 0.02). In Population 2, iPTH increased to a similar extent in both treatment groups. In Population 3, iPTH concentrations in both treatment groups decreased to a similar degree (-29.6 and -11.4 pg/ml for SFOH and SEV, respectively; p = 0.87). CONCLUSIONS: In contrast with SEV, SFOH did not appear to impact the iPTH-lowering effect of oral VDRAs.

Incremental cost-utility of sevelamer relative to calcium carbonate for treatment of hyperphosphatemia among pre-dialysis chronic kidney disease patients.[Pubmed:27121505]

BMC Nephrol. 2016 Apr 28;17(1):45.

BACKGROUND: Sevelamer is an alternative to calcium carbonate for the treatment of hyperphosphatemia among non-dialysis dependent patients with chronic kidney disease (CKD). Although some studies show that it may reduce mortality and delay the onset of dialysis when compared to calcium carbonate, it is also significantly more expensive. Prior studies looking at the incremental cost-effectiveness of sevelamer versus calcium carbonate in pre-dialysis patients are based on data from a single clinical trial. The goal of our study is to use a wider range of clinical data to achieve a more contemporary and robust cost-effectiveness analysis. METHODS: We used a Markov model to estimate the lifetime costs and quality-adjusted life years (QALYs) gained for treatment with sevelamer versus calcium carbonate. The model simulated transitions among three health states (CKD not requiring dialysis, end-stage renal disease, and death). Data on transition probabilities and utilities were obtained from the published literature. Costs were calculated from a third party payer perspective and included medication, hospitalization, and dialysis. Sensitivity analyses were also run to encompass a wide range of assumptions about the dose, costs, and effectiveness of sevelamer. RESULTS: Over a lifetime, the average cost per patient treated with sevelamer is S$180,724. The estimated cost for patients treated with calcium carbonate is S$152,988. A patient treated with sevelamer gains, on average, 6.34 QALYs relative to no treatment, whereas a patient taking calcium carbonate gains 5.81 QALYs. Therefore, sevelamer produces an incremental cost-effectiveness ratio (ICER) of S$51,756 per QALY gained relative to calcium carbonate. CONCLUSION: Based on established benchmarks for cost-effectiveness, sevelamer is cost effective relative to calcium carbonate for the treatment of hyperphosphatemia among patients with chronic kidney disease initially not on dialysis.

Sevelamer carbonate reduces the risk of hypomagnesemia in hemodialysis-requiring end-stage renal disease patients.[Pubmed:27274837]

Clin Kidney J. 2016 Jun;9(3):481-5.

BACKGROUND: Sevelamer has been associated with less progression of vascular calcifications. This effect could be due to a reduction in serum phosphate levels but also to other additive effects. Magnesium has been also shown to prevent vascular calcification but the effect of sevelamer on serum magnesium levels has not been thoroughly evaluated. Our aim was to analyze whether the use of sevelamer reduces the risk of hypomagnesemia in hemodialysis (HD)-requiring end-stage renal disease patients. METHODS: All prevalent patients from the dialysis unit of the Hospital Italiano de Buenos Aires as of 1 June 2015 were evaluated. They were on three times per week bicarbonate/citrate-buffered HD. They were not receiving phosphate binders or magnesium-containing drugs. The average of three successive monthly magnesium serum levels was considered as the baseline magnesium concentration. Sevelamer Carbonate use was retrieved from the patient's clinical records. RESULTS: One hundred and fifty-one patients were included. A large proportion of individuals were on proton pump inhibitors (PPIs) (66%) and more than 50% were using Sevelamer Carbonate. Serum magnesium levels were significantly higher in those receiving sevelamer compared with those who did not (2.05 +/- 0.3 versus 1.8 +/- 0.4 mg/dL; P < 0.05). A larger proportion of individuals receiving sevelamer were among those with normal serum magnesium (P = 0.02), while among those with hypomagnesemia, a larger proportion were on PPIs. In the multivariate model including the use of PPIs, Sevelamer Carbonate resulted in an independent protective factor for hypomagnesemia (odds ratio: 0.44; 95% confidence interval: 0.21-0.87). CONCLUSIONS: Hemodialysis patients receiving sevelamer show higher serum magnesium levels and a reduced risk of hypomagnesemia. This effect remains even after adjustment for PPI use. This effect could contribute to the still controversial superiority of sevelamer in preventing vascular calcifications.

Sevelamer Carbonate and Lanthanum Usage Evaluation and Cost Considerations at a Veteran's Affairs Medical Center.[Pubmed:27303079]

Hosp Pharm. 2016 Apr;51(4):312-9.

BACKGROUND: Hyperphosphatemia is a common problem in patients with chronic kidney disease (CKD). Calcium-containing phosphate binders are typically used as first-line therapy, primarily due to cost considerations. Non-calcium phosphate binders such as sevelamer and lanthanum may be considered in the appropriate setting. It is hypothesized that lanthanum is less costly and has a lower pill burden compared to Sevelamer Carbonate. OBJECTIVE: Determine the difference in cost (outcome 1) and tablet burden (outcome 2) between Sevelamer Carbonate and lanthanum within the Veteran population. METHODS: Patients with an active prescription for lanthanum or Sevelamer Carbonate on October 22, 2014 were evaluated. Chi-square analysis was used to analyze categorical data, and 2-sided t test was used for continuous data. An alpha of 0.05 determined significance. RESULTS: One hundred fifty patients were included in the evaluation. Patients were predominately male (96%) and had a diagnosis of end stage renal disease (ESRD; 78%). The combined rate of non-dialysis CKD (ND-CKD) stage 5 and ESRD was similar between lanthanum and Sevelamer Carbonate groups. Both groups achieved similar phosphorus control (56% vs 65%, with phosphorus level less than or equal to 5.5 mg/dL, respectively; P = .23). Lanthanum prescriptions required significantly fewer tablets per day (4 lanthanum tablets daily vs 7 Sevelamer Carbonate tablets daily; P < .001). A potential prescription cost savings of approximately $4,500 monthly or $54,000 annually was seen when considering conversion of patients in this study population from Sevelamer Carbonate to lanthanum therapy, with appreciable savings beginning at sevelamer daily doses of at least 4,800 mg. CONCLUSIONS: Compared to Sevelamer Carbonate, lanthanum use was associated with reduced pill burden and lower absolute drug cost while maintaining similar phosphorus control.

Sevelamer carbonate is a non-absorbed phosphate binding crosslinked polymer, with the same polymeric structure as sevelamer hydrochloride, in which carbonate replaces chloride as the counterion.

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