Chronic Acid–Base Perturbations in Hemodialysis Patients Treated with Sevelamer Hydrochloride: A Two‐year Follow‐up Study

Vlahakos, Demetrios; Retsa, Kalliopi; Kalogeropoulou, Sofia; Katsoudas, Spiros; Bacharaki, Dimitra; Agroyannis, B.

doi:10.1111/j.1525-1594.2007.00484.x

“…For 2 years, the Greek investigators tracked 14 patients who were stabilized with hemodialysis and either sevelamer hydrochloride or a calcium-based regimen. 16 The authors reported that serum bicarbonate concentrations in the sevelamer group were significantly lower early and remained lower than those observed in the calcium-based group throughout the study (p<0.01). Results were a bit difficult to interpret, as the researchers never reported the mean serum bicarbonate concentrations for either group.…”

Section: Risk Of Metabolic Acidosis With Sevelamer Hydrochloridementioning

confidence: 87%

“…However, reported drawbacks of this agent are metabolic acidosis, high pill burden, and a relatively low affinity and selectivity for phosphate. 11,[15][16][17][18] Sevelamer carbonate ( Figure 2) is a new buffered formulation that does not increase the risk of metabolic acidosis. 19 As such, it may be a better treatment alternative than sevelamer hydrochloride for patients who require sevelamer therapy.…”

Section: Mechanism Of Action and Pharmacology Of Nonabsorbable Exchanmentioning

confidence: 99%

Comparison of Sevelamer Hydrochloride and Sevelamer Carbonate: Risk of Metabolic Acidosis and Clinical Implications

Pai

¹

,

Shepler

²

2009

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Hyperphosphatemia is highly prevalent in patients with chronic kidney disease (CKD), particularly in those with advanced or end-stage renal disease. Sevelamer hydrochloride is an ion-exchange resin that reduces serum phosphorus concentrations. The agent also produces favorable lipid profile effects and does not cause hypercalcemia. However, reported drawbacks of this agent are metabolic acidosis, high pill burden, and a relatively low affinity and selectivity for phosphate anions. Sevelamer carbonate is a new buffered formulation that does not increase the risk of metabolic acidosis. To determine the roles of these two agents in the treatment of hyperphosphatemia in patients with CKD, we performed a MEDLINE search (June 1995-June 2008) focusing on the mechanism of action of resin binding with phosphate and the development of metabolic acidosis. We also reviewed studies that evaluated the effects of sevelamer hydrochloride or sevelamer carbonate on serum bicarbonate concentrations. Several studies in patients with CKD and hyperphosphatemia who received hemodialysis or peritoneal dialysis found decreases in serum bicarbonate concentrations with the use of sevelamer hydrochloride, whereas sevelamer carbonate did not have this negative effect on bicarbonate concentrations. Both drugs appear to be equivalent in their abilities to lower serum phosphorus concentrations. However, as sevelamer carbonate does not decrease serum bicarbonate levels, it may be more appropriate for patients at risk for metabolic acidosis who require phosphate binders that do not contain calcium or aluminum.

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“…Confounding any studies is the concomitant use of sodium bicarbonate supplementation, and underlying deterioration in renal production of bicarbonate. Vlahakos et al56 demonstrated a drop in serum pH and serum bicarbonate levels with sevelamer introduction, followed by a partial but incomplete recuperation over a 2-year period. In contrast, the use of calcium carbonate had no effect on these measurements.…”

Section: Safety and Tolerabilitymentioning

confidence: 99%

Update and critical appraisal of sevelamer in the management of chronic renal failure

Grinfeld

¹

,

Inaba²,

Hutchison

³

2010

OAJU

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Sevelamer (Renagel and Renvela), is an orally administered weakly basic anion exchange resin that binds dietary phosphate in the gastrointestinal tract, and is approved for use in the US, Europe and many other countries for the treatment of hyperphosphatemia in adult patients on hemodialysis or peritoneal dialysis. Clinical evidence shows that sevelamer is at least as effective as calcium-based oral phosphate binders in controlling serum phosphate, but with a lower incidence of hypercalcemia. Whilst sevelamer hydrochloride is associated with mild acidosis, sevelamer carbonate does not have this drawback. Use of sevelamer and avoidance of calcium-based binders may slow the progression of vascular calcification in hemodialysis patients, and it also reduces serum low-density lipoprotein-cholesterol levels. There was no between-group difference in all-cause mortality between sevelamer and calcium-based phosphate binder therapy in the primary efficacy analysis of the large (n >2100), 3-year DCOR trial. In the smaller (n = 109) nonblind RIND trial in patients new to hemodialysis, data suggest there may be an overall survival benefit with sevelamer versus calcium-based phosphate binder treatment but the evidence on the efficacy of sevelamer in reducing mortality and hospitalization is not strong. The balance of evidence, however, does not strongly support the use of sevelamer over the much less costly calcium-based binders except in patients at risk of hypercalcemic episodes. Further research into cardiovascular and all-cause mortality over a longer time period would be needed to settle this issue, and the relative survival benefits and cost effectiveness of all phosphate binder therapies remains to be fully determined. Despite the relative paucity of data available, sevelamer has established itself as the most widely used binder in the United States and the most widely used noncalcium-based binder worldwide. However, affordability is a major issue for most health economies and in the light of recent economic events is likely to become more prominent.

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“…With the exception of one earlier study by Chertow et al 53 which showed a slight initial increase in sodium bicarbonate concentrations in a 46-week trial, there is general consensus that metabolic acidosis develops in the weeks after commencing sevelamer hydrochloride. [54][55][56][57] However, the chronicity of the acidosis is unclear. Confounding any studies is the concomitant use of sodium bicarbonate supplementation, and underlying deterioration in renal production of bicarbonate.…”

Section: Safety and Tolerability Metabolic Acidosismentioning

confidence: 99%

Update and critical appraisal of sevelamer in the management of chronic renal failure

Hutchison¹

2010

RRU

0

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Sevelamer (Renagel and Renvela), is an orally administered weakly basic anion exchange resin that binds dietary phosphate in the gastrointestinal tract, and is approved for use in the US, Europe and many other countries for the treatment of hyperphosphatemia in adult patients on hemodialysis or peritoneal dialysis. Clinical evidence shows that sevelamer is at least as effective as calcium-based oral phosphate binders in controlling serum phosphate, but with a lower incidence of hypercalcemia. Whilst sevelamer hydrochloride is associated with mild acidosis, sevelamer carbonate does not have this drawback. Use of sevelamer and avoidance of calcium-based binders may slow the progression of vascular calcification in hemodialysis patients, and it also reduces serum low-density lipoprotein-cholesterol levels. There was no between-group difference in all-cause mortality between sevelamer and calcium-based phosphate binder therapy in the primary efficacy analysis of the large (n >2100), 3-year DCOR trial. In the smaller (n = 109) nonblind RIND trial in patients new to hemodialysis, data suggest there may be an overall survival benefit with sevelamer versus calcium-based phosphate binder treatment but the evidence on the efficacy of sevelamer in reducing mortality and hospitalization is not strong. The balance of evidence, however, does not strongly support the use of sevelamer over the much less costly calcium-based binders except in patients at risk of hypercalcemic episodes. Further research into cardiovascular and all-cause mortality over a longer time period would be needed to settle this issue, and the relative survival benefits and cost effectiveness of all phosphate binder therapies remains to be fully determined. Despite the relative paucity of data available, sevelamer has established itself as the most widely used binder in the United States and the most widely used noncalcium-based binder worldwide. However, affordability is a major issue for most health economies and in the light of recent economic events is likely to become more prominent.

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Chronic Acid–Base Perturbations in Hemodialysis Patients Treated with Sevelamer Hydrochloride: A Two‐year Follow‐up Study

Cited by 10 publications

References 14 publications

Comparison of Sevelamer Hydrochloride and Sevelamer Carbonate: Risk of Metabolic Acidosis and Clinical Implications

Comparison of Sevelamer Hydrochloride and Sevelamer Carbonate: Risk of Metabolic Acidosis and Clinical Implications

Update and critical appraisal of sevelamer in the management of chronic renal failure

Update and critical appraisal of sevelamer in the management of chronic renal failure

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