An evaluation of sodium zirconium cyclosilicate as a treatment option for hyperkalemia

References

• Bastl C, Hayslett JP, Binder HJ. Increased large intestinal secretion of potassium in renal insufficiency. Kidney Int. 1977;12(1):9–16.
   PubMed Web of Science ®Google Scholar
• Sarafidis P, Blacklock R, Wood E, et al. Prevalence and factors associated with hyperkalemia in predialysis patients followed in a low clearance clinic. Clin J Am Soc Nephrol. 2012;7(8):1234–1241.
   PubMed Web of Science ®Google Scholar
• Grodzinsky A, Goyal A, Kosiborod. Prevalence and prognosis of hyperkalemia in patients with acute myocardial infarction. Am J Med. 2016;129(8):858–865.
   PubMed Web of Science ®Google Scholar
• Goyal A, Spertus JA, Gosch K, et al. Serum potassium levels and mortality in acute myocardial infarction. JAMA. 2012;307:157–164.
   PubMed Web of Science ®Google Scholar
• Einhorn LM, Zhan M, Hsu VD, et al. The frequency of hyperkalemia and its significance in chronic kidney disease. Arch Intern Med. 2009;169(12):1156–1162.
   PubMed Web of Science ®Google Scholar
• Lazich I, Bakris GL. Prediction and management of hyperkalemia across the spectrum of chronic kidney disease. Semin Nephrol. 2014;34(3):333–339.
   PubMed Web of Science ®Google Scholar
• Kovesdy CP. Management of hyperkalaemia in chronic kidney disease. Nat Rev Nephrol. 2014;10:653–662.
   PubMed Web of Science ®Google Scholar
• Makani H, Bangalore S, Desouza KA, et al. Efficacy and safety of dual blockade of the renin-angiotensin system: meta-analysis of randomised trials. BMJ. 2013;346:f360.
   PubMedGoogle Scholar
• Epstein M. Reduction of cardiovascular risk in chronic kidney disease by mineralocorticoid receptor antagonism. Lancet Diabetes Endocrinol. 2015;3:993–1003.
   PubMed Web of Science ®Google Scholar
• Kovesdy CP. Updates in hyperkalemia: outcomes and therapeutic strategies. Rev Endocr Metab Disord. 2017 Mar;18(1):41–44.
   PubMed Web of Science ®Google Scholar
• Yildirim T, Arici M, Piskinpasa S, et al. Major barriers against renin angiotensin- aldosterone system blocker use in chronic kidney disease stages 3–5 in clinical practice: a safety concern? Ren Fail. 2012;34:1095–1099.
   PubMed Web of Science ®Google Scholar
• Krantz MJ, Ambardekar AV, Kaltenbach L, et al. Patterns and predictors of evidence-based medication continuation among hospitalized heart failure patients (from Get With the Guidelines – heart Failure). Am J Cardiol. 2011;107:1818–1823.
   PubMed Web of Science ®Google Scholar
• Clase CM 1, Carrero JJ 2, Ellison DH 3, et al. Potassium homeostasis and management of dyskalemia in kidney diseases: conclusions from a kidney disease: improving global outcomes (KDIGO) controversies conference. Kidney Int. 2019 Oct 10:S0085-2538(19)31012–9. [Epub ahead of print]. DOI:https://doi.org/10.1016/j.kint.2019.09.018.
   Google Scholar
• Palmer BF, Clegg DJ. Achieving the benefits of a high-potassium, paleolithic diet, without the toxicity. Mayo Clin Proc. 2016;91:496–508.
   PubMed Web of Science ®Google Scholar
• Uribarri J, Oh M. The key to halting progression of CKD might be in the produce market, not in the pharmacy. Kidney Int. 2012;81:7–9.
   PubMed Web of Science ®Google Scholar
• Chauveau P, Lasseur C. Plant-based protein intake and kidney function in diabetic patients. Kidney Int Rep. 2019;4:638–639.
   PubMed Web of Science ®Google Scholar
• Sterns RH, Rojas M, Bernstein P, et al. Ion-exchange resins for the treatment of hyperkalemia: are they safe and effective? J Am Soc Nephrol. 2010;21:733–735.
   PubMed Web of Science ®Google Scholar
• Parks M, Grady D. Sodium polystyrene sulfonate for hyperkalemia. JAMA Intern Med. 2019;179:1023–1024.
   PubMed Web of Science ®Google Scholar
• Scherr L, Ogden DA, Mead AW, et al. Management of hyperkalemia with a cation-exchange resin. N Engl J Med. 1961;264:115–119.
   PubMed Web of Science ®Google Scholar
• Flinn RB, Merrill JP, Welzan WR. Treatment of the oliguric patient with a new sodium ion-exchange resin and sorbitol: a preliminary report. N Engl J Med. 1961;264:111–115.
   PubMed Web of Science ®Google Scholar
• Lepage L, Dufour AC, Doiron J, et al. Randomized clinical trial of sodium polystyrene sulfonate for the treatment of mild hyperkalemia in CKD. Clin J Am Soc Nephrol. 2015;12:2136–2142.
   Google Scholar
• Watson M, Abbott KC, Yuan CM. Damned if you do, damned if you don’t: potassium binding resins in hyperkalemia. Clin J Am Soc Nephrol. 2010;5:1723–1726.
   PubMed Web of Science ®Google Scholar
• Chernin G, Gal-Oz A, Ben-Assa E, et al. Secondary prevention of hyperkalemia with sodium polystyrene sulfonate in cardiac and kidney patients on renin-angiotensin-aldosterone system inhibition therapy. Clin Cardiol. 2012;35:32–36.
   PubMed Web of Science ®Google Scholar
• Kayexalate (sodium polystyrene sulfonate, USP). [package insert]. Bridgewater, NJ: Sanofi-Aventis; 2009.
   Google Scholar
• Gerstman BB, Kirkman R, Platt R. Intestinal necrosis associated with postoperative orally administered sodium polystyrene sulfonate in sorbitol. Am J Kidney Dis. 1992;2:159–161.
   Google Scholar
• Cheng ES, Stringer KM, Pegg SP. Colonic necrosis and perforation following oral sodium polystyrene sulfonate (Resonium A/Kayexalate) in a burn patient. Burns. 2002;2:189–190.
   Google Scholar
• US food and drug administration: kayexalate (sodium polystyrene sulfonate) powder. Available from: http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm186845
   Google Scholar
• Harel Z, Harel S, Shah PS, et al. Gastrointestinal adverse events with sodium polystyrene sulfonate (Kayexalate) use: a systematic review. Am J Med. 2013;3(264):e9–24.
   Google Scholar
• McGowan CE, Saha S, Chu G, et al. Intestinal necrosis due to sodium polystyrene sulfonate (Kayexalate) in sorbitol. South Med J. 2009;102:493–497.
   PubMed Web of Science ®Google Scholar
• Weir MR, Bakris GL, Bushinsky DA, et al. Patiromer in patients with kidney disease and hyperkalemia receiving RAAS inhibitors. N Engl J Med. 2015;372:211.
   PubMed Web of Science ®Google Scholar
• Bakris GL, Pitt B, Weir MR, et al. Effect of patiromer on serum potassium level in patients with hyperkalemia and diabetic kidney disease: the AMETHYST-DN randomized clinical trial. JAMA. 2015;314:151.
   PubMed Web of Science ®Google Scholar
• Bushinsky DA, Spiegel DM, Gross C, et al. Effect of patiromer on urinary ion excretion in healthy adults. Clin J Am Soc Nephrol. 2016;11:1769.
   PubMed Web of Science ®Google Scholar
• AULesko LJ, Offman E, Brew CT, et al. Evaluation of the potential for drug interactions with patiromer in healthy volunteers. SO J Cardiovasc Pharmacol Ther. 2017;22(5):434.
   PubMed Web of Science ®Google Scholar
• Veltessa (patiromer) for oral suspension. 2015 Full Prescribing Information Redwood City, California: Relypsa, Inc. updated 2015 Oct; cited 2015 Oct; cited 2015 Oct; cited 2015 Dec 2 Available from: http://www.relypsa.com/veltassa/prescribing-information
   Google Scholar
• Bushinsky DA, Williams GH, Pitt B, et al. Patiromer induces rapid and sustained potassium lowering in patients with chronic kidney disease and hyperkalemia. Kidney Int. 2015 Dec;88(6):1427–1433.
   PubMed Web of Science ®Google Scholar
• Rafique Z, Liu M, Staggers KA, et al. Patiromer for treatment of hyperkalemia in the emergency department: a pilot study. Acad Emerg Med. 2020 Jan;27(1):54–60.
   PubMed Web of Science ®Google Scholar
• Stavros F, Yang A, Leon A, et al. Characterization of structure and function of ZS-9, a K+ selective ion trap. PLoS ONE. 2014;9(12):e114686..
   PubMed Web of Science ®Google Scholar
• Linder KE, Krawczynski MA, Laskey D. Sodium zirconium cyclosilicate (ZS-9): a novel agent for the treatment of hyperkalemia. Pharmacotherapy. 2016 Aug;36(8):923–933.
   PubMed Web of Science ®Google Scholar
• Kosiborod M, Rasmussen HS, Lavin P, et al. Effect of sodium zirconium cyclosilicate on potassium lowering for 28 days among outpatients with hyperkalemia: the HARMONIZE randomized clinical trial. JAMA. 2014;312(21):2223–2233.
   PubMed Web of Science ®Google Scholar
• Packham DK, Rasmussen HS, Lavin PT, et al. Sodium zirconium cyclosilicate in hyperkalemia. N Engl J Med. 2015;372:222–231.
   PubMed Web of Science ®Google Scholar
• AstraZeneca. Lokelma (sodium zirconium cyclosilicate) for oral suspension: EU summary of product characteristics. 2018. [cited 2018 Aug 3]. http://www.ema.europ a.eu/ema/
   Google Scholar
• AstraZeneca. Lokelma™ (sodium zirconium cyclosilicate) for oral suspension: US prescribing information. 2018 cited 2018 Aug 3 http://www. fda.gov/
   Google Scholar
• Ash SR, Singh B, Lavin PT, et al. A phase 2 study on the treatment of hyperkalemia in patients with chronic kidney disease suggests that the selective potassium trap, ZS-9, is safe and efficient. Kidney Int. 2015;88:404–411.
   PubMed Web of Science ®Google Scholar
• Roger SD, Rasmussen HS, Lavin PT, et al. Effect of ZS-9 on serum bicarbonate and BUN in a Phase 3 randomized, double-blind, placebo-controlled trial. Am Soc Nephrol Kidney Week. 2014:2743. abstract.
   Google Scholar
• Hoy S. Sodium zirconium cyclosilicate: a review in hyperkalaemia. Drugs. 2018;78:1605–1613.
   PubMed Web of Science ®Google Scholar
• Pitt B, Anker SD, Bushinsky DA, et al. Evaluation of the efficacy and safety of RLY5016, a polymeric potassium binder, in a double-blind, placebo-controlled study in patients with chronic heart failure (the PEARL-HF) trial. Eur Heart J. 2011;32:820–828.
   PubMed Web of Science ®Google Scholar
• Pergola PE, Spiegel DM, Warren S, et al. Patiromer lowers serum potassium when taken without food: comparison to dosing with food from an open-label, randomized, parallel group hyperkalemia study. Am J Nephrol. 2017;46:323–332.
   PubMed Web of Science ®Google Scholar
• Anker SD, Kosiborod M, Zannad F, et al. Maintenance of serum potassium with sodium zirconium cyclosilicate (ZS-9) in heart failure patients: results from a phase 3 randomized, double-blind, placebo-controlled trial. Eur J Heart Fail. 2015 Oct;17(10):1050–1056.
   PubMed Web of Science ®Google Scholar
• Spinowitz BS, Fishbane S, Pergola PE, et al. Sodium zirconium cyclosilicate among individuals with hyperkalemia: a 12-month phase 3 study. Clin J Am Soc Nephrol. 2019 Jun 7;14(6):798–809.
   PubMed Web of Science ®Google Scholar
• Fishbane S, Ford M, Fukagawa M, et al. A phase 3b, randomized, double-blind, placebo-controlled study of sodium zirconium cyclosilicate for reducing the incidence of predialysis hyperkalemia. J Am Soc Nephrol. 2019 Sep;30(9):1723–1733.
   PubMed Web of Science ®Google Scholar
• Pitt B, Bakris GL, Bushinsky DA, et al. Effect of patiromer on reducing serum potassium and preventing recurrent hyperkalaemia in patients with heart failure and chronic kidney disease on RAAS inhibitors. Eur J Heart Fail. 2015;17:1057–1065.
   PubMed Web of Science ®Google Scholar
• Peacock WF, Rafique Z, Vishnevskiy K, et al. Emergency potassium normalization treatment including sodium zirconium cyclosilicate: a phase II, randomized, double-blind, placebo-controlled study (ENERGIZE). Acad Emerg Med. 2020 Jun;27(6):475–486. Epub 2020 Mar 28.
   PubMed Web of Science ®Google Scholar