Sevelamer 'carbonate': what's in a name?

Harland, C. E.; Wrong, Oliver

doi:10.1093/ndt/gfp686

Cited by 5 publications

(4 citation statements)

References 6 publications

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“…Sevelamer is a polymeric ion-exchange phosphate binder, available as sevelamer hydrochloride and, more recently, also as sevelamer “carbonate.” Technically, sevelamer carbonate is not an accurate name, because the resin exists only as a mix of the free amine and bicarbonate forms—the carbonate form being too unstable, except in very alkaline conditions (13). In the present study, we followed convention and used the name “sevelamer carbonate” per the product monograph.…”

mentioning

confidence: 99%

Pre-Treatment of Dairy and Breast Milk with Sevelamer Hydrochloride and Sevelamer Carbonate to Reduce Phosphate

et al. 2013

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♦ Introduction: Young children and infants with chronic kidney disease are at increased risk of hyperphosphatemia because of high intake of dairy products. Hyperphos phatemia leads to metastatic calcifications and an increased risk of cardiovascular complications. Sevelamer is an effec tive phosphate binder, but for children it has important practical disadvantages: it clogs enteral feeding tubes and can cause gastrointestinal complaints. Pretreatment of dairy products to reduce their phosphate content might solve those problems. ♦ Methods: Sevelamer hydrochloride and sevelamer carbon ate were suspended in various dairy products (cow's milk, breast milk, baby formula, and tubefeeding formula). Each product was tested with varying concentrations of sevelamer. After suspension, each sample was stored for 10 minutes, allowing the sevelamer to precipitate. The supernatant was decanted and analyzed for pH and for phosphate, calcium, magnesium, potassium, sodium, and chloride content. ♦ Results: We observed a significant decrease in the phosphate content of all tested products. With sevelamer hydrochloride, the phosphate reduction was 48% -91% in the various products, and with sevelamer carbonate, it was 22% -87%. The highest effectiveness was found in breast milk. A pH increase was found in all products. With sevelamer hydrochloride, a significant increase in chloride occurred. Notably, a significant decrease in calcium content (-75%) was observed in treated breast milk. ♦ Conclusions: Pretreatment of a variety of dairy products with either sevelamer hydrochloride or sevelamer carbon ate effectively reduced their phosphate content and might avoid troublesome ingestion of sevelamer in children. The change in pH with sevelamer hydrochloride was remark able, reflecting buffering mechanisms. The reduction in the calcium content of breast milk is a potential concern and should be carefully considered and monitored during clinical use of sevelamer.

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confidence: 99%

Pre-Treatment of Dairy and Breast Milk with Sevelamer Hydrochloride and Sevelamer Carbonate to Reduce Phosphate

et al. 2013

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“…52 It should be mentioned that there are some concerns about the name of sevelamer "carbonate", as the resin dissociates into free sevelamer and sevelamer "bicarbonate" in the acidic pH of gastrointestinal tract, which is well below the isoelectric pH of sevelamer "carbonate". 53 The other side effect of sevelamer is increased risk of gastrointestinal upset, including abdominal bloating, diarrhea, and constipation compared with calcium salts (RR: 1.39). 39…”

Section: Safety Issue: Metabolic Acidosismentioning

confidence: 99%

Clinical and economic aspects of sevelamer therapy in end-stage renal disease patients

Ossareh

2014

IJNRD

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Phosphate control is still a great challenge in chronic kidney disease (CKD), and in spite of the great improvements in dialysis techniques, achievement of the goals for mineral metabolism control is still far from ideal. Aluminum hydroxide has been largely abandoned due to the high risk of aluminum toxicity, while the use of calcium-based phosphate binders may cause hypercalcemia, overzealous parathyroid suppression, and extraskeletal calcification. Sevelamer hydrochloride has been introduced as an efficient medication for phosphate control, with a lower risk of hypercalcemia and parathyroid suppression. Various clinical trials have compared the risk of vascular calcification between sevelamer and calcium salts with inconsistent results. In spite of these inconsistencies, the Kidney Disease Outcomes Quality Initiative (KDOQI) suggests non-calcium phosphate binders as the preferred phosphate binder in dialysis patients with severe vascular and/or other soft-tissue calcifications and in those with hypercalcemia or parathyroid hormone (PTH) <150 mg/dL. The Kidney Disease Improving Global Outcome (KDIGO) limits the use of non-calcium phosphate binders to patients with hypercalcemia. Regarding the effect on mortality, the results of clinical trials are again inconsistent. The other important aspect of using sevelamer is the issue of price, which is substantially higher than calcium-based phosphate binders. Reviewing the studies on economic aspects shows that sevelamer increases quality-adjusted life-years (QALY) and possibly life years, with a higher cost compared to calcium-based phosphate binders. In conclusion, sevelamer is a very useful drug for phosphate control, reduction of hypercalcemia, and lessening the risk of adynamic bone disease, with probable reduction in vascular calcification and possible reduction in mortality rate. It has a higher economic burden on health care systems compared to calcium-based phosphate binders. This may affect its extensive use according to guideline recommendations, and will be influenced by local health care budgets and the decision of health care strategists.

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“…However, Renvela is not currently available in most European countries, and Harland58 argues that it is misnamed since it does not contain carbonate.…”

Section: Safety and Tolerabilitymentioning

confidence: 99%

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

Grinfeld

Inaba²,

Hutchison

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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Sevelamer 'carbonate': what's in a name?

Cited by 5 publications

References 6 publications

Pre-Treatment of Dairy and Breast Milk with Sevelamer Hydrochloride and Sevelamer Carbonate to Reduce Phosphate

Pre-Treatment of Dairy and Breast Milk with Sevelamer Hydrochloride and Sevelamer Carbonate to Reduce Phosphate

Clinical and economic aspects of sevelamer therapy in end-stage renal disease patients

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

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