A Review of Sucroferric Oxyhydroxide for the Treatment of Hyperphosphatemia in Patients Receiving Dialysis

Bousher, Ava; Al-Makki, Akram; Sutton, James; Shepler, Brian

doi:10.1016/j.clinthera.2014.09.021

Cited by 5 publications

(4 citation statements)

References 16 publications

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“…However, generalizability has no value in the absence of internal validity, which is challenging to attain with a prevalent user design owing to risk of bias from depletion of susceptible patients. Second, USRDS data are released with a lag of 3 years, and we were thus not able to include the iron-based phosphate binders sucroferric oxyhydroxide (US Food and Drug Administration [FDA] approval in 2013) and ferric citrate (FDA approval in 2014) into our analyses . However, in 2018, less than 10% of patients in the United States undergoing HD were receiving these drugs .…”

Section: Discussionmentioning

confidence: 99%

Cardiovascular Outcomes of Calcium-Free vs Calcium-Based Phosphate Binders in Patients 65 Years or Older With End-stage Renal Disease Requiring Hemodialysis

et al. 2019

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IMPORTANCE Guidelines restricting use of calcium-based phosphate binders in all patients with end-stage renal disease owing to their potential contribution to increased cardiovascular risk shifted prescribing from calcium acetate toward the costlier sevelamer carbonate products. OBJECTIVE To compare cardiovascular events and mortality between patients with end-stage renal disease (ESRD) undergoing hemodialysis receiving sevelamer vs calcium acetate in real-world practice. DESIGN, SETTING, AND PARTICIPANTS An observational cohort study was conducted using the United States Renal Data System linked to Medicare claims data (May 1, 2012, to December 31, 2013). Data analysis was performed from October 2017 to September 2018. Participants included patients 65 years or older with ESRD within 180 days after starting hemodialysis (sevelamer, 2647; calcium acetate, 2074). EXPOSURES New use of sevelamer (calcium-free phosphate binder) vs calcium acetate (calcium-based phosphate binder). MAIN OUTCOMES AND MEASURES Hazard ratios (HRs) with 95% CIs were estimated for fatal or nonfatal cardiovascular events (myocardial infarction or ischemic stroke: primary outcome) and all-cause mortality (secondary outcome) using Cox proportional hazards regression with fine stratification on the propensity score to control for potential confounders, including phosphorus and calcium levels. RESULTS After propensity score weighting, 2639 patients initiating sevelamer treatment (1184 men [44.9%]; mean [SD] age, 75.6 [6.9] years) and 2065 patients initiating calcium acetate treatment (930 men [45.0%]; mean [SD] age, 75.5 [7.1] years) were included in the analysis. Crude incidence rates (IRs) for cardiovascular events of 458 per 1000 person-years for sevelamer and 464 per 1000 person-years for calcium acetate were observed. After propensity score fine-stratification weighting, HRs of 0.96 (95% CI, 0.84-1.10) for cardiovascular events were observed. Results were consistent within subgroups of age (<75 y: primary outcome, HR, 1.02; 95% CI, 0.85-1.24; vs Ն75 years: primary outcome, HR, 0.83; 95% CI, 0.69-1.01) and sex (primary outcome in men: HR, 1.02; 95% CI, 0.83-1.26). CONCLUSIONS AND RELEVANCE The results of the study do not suggest increased cardiovascular safety of sevelamer in the routine clinical practice of patients with ESRD compared with calcium acetate; this study's findings suggest that well-designed, long-term, randomized clinical trials are needed.

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Section: Discussionmentioning

confidence: 99%

Cardiovascular Outcomes of Calcium-Free vs Calcium-Based Phosphate Binders in Patients 65 Years or Older With End-stage Renal Disease Requiring Hemodialysis

et al. 2019

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“…Current clinical guidelines recommend strict dietary restriction of phosphate intake in addition to maintenance dialysis to control hyperphosphataemia in patients with advanced CKD 6,7 . These, however, provide insufficient phosphorus‐lowering capacity in serum, emphasizing the importance of treatment with phosphate binders to prevent additional absorption of dietary phosphate via the gastrointestinal (GI) tract.…”

Section: Introductionmentioning

confidence: 99%

“…5 Current clinical guidelines recommend strict dietary restriction of phosphate intake in addition to maintenance dialysis to control hyperphosphataemia in patients with advanced CKD. 6,7 These, however, provide insufficient phosphorus-lowering capacity in serum, emphasizing the importance of treatment with phosphate binders to prevent additional absorption of dietary phosphate via the gastrointestinal (GI) tract. Currently, different classes of phosphate binders are prescribed to CKD patients, but there are still some underlying drawbacks associated with each class that may affect patient compliance and safety.…”

Section: Introductionmentioning

confidence: 99%

Ferric citrate in the management of hyperphosphataemia and iron deficiency anaemia: A meta‐analysis in patients with chronic kidney disease

Choi

Noh

Shin

2020

Brit J Clinical Pharma

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Aims Phosphate‐lowering effects of ferric citrate were reported in several clinical trials, but mostly in small‐scale studies. The aim of this meta‐analysis was to investigate the efficacy and safety of ferric citrate in controlling hyperphosphataemia and iron‐deficiency anaemia in chronic kidney disease (CKD) patients. Methods PubMed, Embase and Cochrane Library were searched for clinical trials that enrolled CKD patients receiving ferric citrate for hyperphosphataemia. Two investigators performed systematic literature search to identify eligible studies, evaluated risk of bias and extracted relevant data. Results Sixteen studies were included in the meta‐analysis. Phosphate‐lowering effects of ferric citrate were greater compared to no active treatment (standardized mean difference [SMD] = −1.15; P < 0.001) and comparable to other phosphate binders (SMD = 0.03; P = 0.61). Calcium concentrations post ferric citrate treatment did not differ compared to no active treatment (SMD = 0.15; P = 0.21) but were significantly lower compared to other phosphate binders (SMD = −0.14; P = 0.01). These led to significant reductions in calcium‐phosphorus product with ferric citrate versus no active control (SMD = −1.02; P < 0.001) but no difference versus active control (SMD = −0.01; P = 0.93). Intact parathyroid hormone showed no substantial between‐group difference in both comparison against no active and active controls. Ferric citrate improved iron stores and anaemia parameters, but increased risk of diarrhoea, abdominal pain and discoloured faeces. Conclusion Ferric citrate was effective in lowering phosphorus and phosphorus‐calcium product versus no active treatment and had comparable effects versus other phosphate binders. Calcium levels were significantly lower with ferric citrate than with other phosphate‐lowering treatment. Ferric citrate had additive effects on iron repletion and anaemia control and was associated with mostly gastrointestinal side effects.

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“…PA21, as well as other phosphate binders, exhibits reducing effects on serum phosphorus levels by combining with phosphates derived from food and inhibiting phosphate absorption in the gastrointestinal (GI) tract [13]. Recent clinical studies indicated that it reduced serum phosphorus levels remarkably [14].…”

Section: Introductionmentioning

confidence: 99%

PA21, a novel phosphate binder, improves renal osteodystrophy in rats with chronic renal failure

et al. 2017

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The effects of PA21, a novel iron-based and non-calcium-based phosphate binder, on hyperphosphatemia and its accompanying bone abnormality in chronic kidney disease-mineral and bone disorder (CKD-MBD) were evaluated. Rats with adenine-induced chronic renal failure (CRF) were prepared by feeding them an adenine-containing diet for four weeks. They were also freely fed a diet that contained PA21 (0.5, 1.5, and 5%), sevelamer hydrochloride (0.6 and 2%) or lanthanum carbonate hydrate (0.6 and 2%) for four weeks. Blood biochemical parameters were measured and bone histomorphometry was performed for femurs, which were isolated after drug treatment. Serum phosphorus and parathyroid hormone (PTH) levels were higher in the CRF rats. Administration of phosphate binders for four weeks decreased serum phosphorus and PTH levels in a dose-dependent manner and there were significant decreases in the AUC0–28 day of these parameters in 5% PA21, 2% sevelamer hydrochloride, and 2% lanthanum carbonate hydrate groups compared with that in the CRF control group. Moreover, osteoid volume improved significantly in 5% of the PA21 group, and fibrosis volume and cortical porosity were ameliorated in 5% PA21, 2% sevelamer hydrochloride, and 2% lanthanum carbonate hydrate groups. These results suggest that PA21 is effective against hyperphosphatemia, secondary hyperparathyroidism, and bone abnormalities in CKD-MBD as sevelamer hydrochloride and lanthanum carbonate hydrate are, and that PA21 is a new potential alternative to phosphate binders.

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A Review of Sucroferric Oxyhydroxide for the Treatment of Hyperphosphatemia in Patients Receiving Dialysis

Cited by 5 publications

References 16 publications

Cardiovascular Outcomes of Calcium-Free vs Calcium-Based Phosphate Binders in Patients 65 Years or Older With End-stage Renal Disease Requiring Hemodialysis

Cardiovascular Outcomes of Calcium-Free vs Calcium-Based Phosphate Binders in Patients 65 Years or Older With End-stage Renal Disease Requiring Hemodialysis

Ferric citrate in the management of hyperphosphataemia and iron deficiency anaemia: A meta‐analysis in patients with chronic kidney disease

PA21, a novel phosphate binder, improves renal osteodystrophy in rats with chronic renal failure

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