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

European Journal of Heart Failure

Volumn 17, Issue 10, 2015, Pages 1050-1056

  Anker, Stefan D ^a   Kosiborod, Mikhail ^b   Zannad, Faiez ^c   Piña, Ileana L ^d   McCullough, Peter A ^e,l   Filippatos, Gerasimos ^f   Van Der Meer, Peter ^g   Ponikowski, Piotr ^h   Rasmussen, Henrik S ⁱ   Lavin, Philip T ^j   Singh, Bhupinder ⁱ   Yang, Alex ⁱ   Deedwania, Prakash ^k  

^a UNIVERSITY MEDICAL CENTER GÖTTINGEN   (Germany)

^b UNIVERSITY OF MISSOURI KANSAS CITY   (United States)

^c UNIVERSITÉ DE LORRAINE   (France)

^d MONTEFIORE MEDICAL CENTER   (United States)

^e BAYLOR UNIVERSITY MEDICAL CENTER   (United States)

^f NATIONAL AND KAPODISTRIAN UNIVERSITY OF ATHENS   (Greece)

^g UNIVERSITY MEDICAL CENTER GRONINGEN   (Netherlands)

^h WROCLAW MEDICAL UNIVERSITY   (Poland)

ⁱ ZS Pharma   (United States)

^j Boston Biostatistics Research Foundation   (United States)

^k UNIVERSITY OF CALIFORNIA   (United States)

^l The Heart Hospital   (United States)

more..

Author keywords

heart failure; hyperkalaemia; RAAS; ZS 9

Indexed keywords

ANGIOTENSIN RECEPTOR ANTAGONIST; DIPEPTIDYL CARBOXYPEPTIDASE INHIBITOR; DIURETIC AGENT; MINERALOCORTICOID ANTAGONIST; PLACEBO; POTASSIUM; SODIUM ZIRCONIUM CYCLOSILICATE; SILICATE; ZS-9 COMPOUND;

ADULT; AGED; ANEMIA; ARTICLE; CONTROLLED STUDY; DISEASE CONTROL; DIZZINESS; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; DRUG WITHDRAWAL; EDEMA; FATIGUE; FEMALE; GASTROINTESTINAL DISEASE; GENERALIZED EDEMA; HEART FAILURE; HUMAN; HYPERKALEMIA; HYPERTENSION; HYPOKALEMIA; MAJOR CLINICAL STUDY; MALE; NAUSEA; OPEN STUDY; PHASE 3 CLINICAL TRIAL; POTASSIUM BLOOD LEVEL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; REFERENCE VALUE; RHINOPHARYNGITIS; TREATMENT DURATION; UPPER RESPIRATORY TRACT INFECTION; BLOOD; CLINICAL TRIAL;

DOUBLE-BLIND METHOD; HEART FAILURE; HUMANS; HYPERKALEMIA; POTASSIUM; SILICATES;

EID: 84946482152     PISSN: 13889842     EISSN: 18790844     Source Type: Journal    
DOI: 10.1002/ejhf.300     Document Type: Article

References (34)

1. An JN, Lee JP, Jeon HJ, Kim DH, Oh YK, Kim YS, Lim CS,. Severe hyperkalemia requiring hospitalization: predictors of mortality. Crit Care 2012; 16: R225.
2. Khanagavi J, Gupta T, Aronow WS, Shah T, Garg J, Ahn C, Sule S, Peterson S,. Hyperkalemia among hospitalized patients and association between duration of hyperkalemia and outcomes. Arch Med Sci 2014; 10: 251-257.
3. Jain N, Kotla S, Little BB, Weideman RA, Brilakis ES, Reilly RF, Banerjee S,. Predictors of hyperkalemia and death in patients with cardiac and renal disease. Am J Cardiol 2012; 109: 1510-1513.
4. Navaneethan SD, Nigwekar SU, Sehgal AR, Strippoli GFM,. Aldosterone antagonists for preventing the progression of chronic kidney disease: a systematic review and meta-analysis. Clin J Am Soc Nephrol 2009; 4: 542-551.
5. Svensson M, Gustafsson F, Galatius S, Hildebrandt PR, Atar D,. How prevalent is hyperkalemia and renal dysfunction during treatment with spironolactone in patients with congestive heart failure? J Card Fail 2004; 10: 297-303.
6. Juurlink DN, Mamdani MM, Lee DS, Kopp A, Austin PC, Laupacis A, Redelmeier DA,. Rates of hyperkalemia after publication of the Randomized Aldactone Evaluation Study. New Engl J Med 2004; 351: 543-551.
7. Kessler C, Ng J, Valdez K, Xie H, Geiger B,. The use of sodium polystyrene sulfonate in the inpatient management of hyperkalemia. J Hosp Med 2011; 6: 136-140.
8. Scherr L, Ogden DA, Mead AW, Spritz N, Rubin AL,. Management of hyperkalemia with a cation-exchange resin. New Engl J Med 1961; 264: 115-119.
9. Flinn RB, Merrill JP, Welzant WR,. Treatment of the oliguric patient with a new sodium-exchange resin and sorbitol; a preliminary report. New Engl J Med 1961; 264: 111-115.
10. Harel Z, Harel S, Shah PS, Wald R, Perl J, Bell CM,. Gastrointestinal adverse events with sodium polystyrene sulfonate (Kayexalate) use: a systematic review. Am J Med 2013; 126: 264.e9-e24.
11. Yuan CM, Nee R, Little DJ, Abbott KC,. Incidence of sodium polystyrene sulfonate-associated colonic necrosis. Am J Med 2013; 126: e13.
12. Watson MA, Baker TP, Nguyen A, Sebastianelli ME, Stewart HL, Oliver DK, Abbott KC, Yuan CM,. Association of prescription of oral sodium polystyrene sulfonate with sorbitol in an inpatient setting with colonic necrosis: a retrospective cohort study. Am J Kidney Dis 2012; 60: 409-416.
13. Castillo-Cejas MD, De-Torres-Ramírez I, Alonso-Cotoner C,. Colonic necrosis due to calcium polystyrene sulfonate (Kalimate) not suspended in sorbitol. Rev Esp Enferm Dig 2013; 105: 232-234.
14. Fordjour KN, Walton T, Doran JJ,. Management of hyperkalemia in hospitalized patients. Am J Med Sci 2014; 347: 93-100.
15. Goraya N, Wesson DE,. Dietary management of chronic kidney disease: protein restriction and beyond. Curr Opin Nephrol Hypertens 2012; 21: 635-640.
16. Łoniewski I, Wesson DE,. Bicarbonate therapy for prevention of chronic kidney disease progression. Kidney Int 2014; 85: 529-535.
17. Pitt B, Remme W, Zannad F, Neaton J, Martinez F, Roniker B, Bittman R, Hurley S, Kleiman J, Gatlin M,. Eplerenone, a selective aldosterone blocker, in patients with left ventricular dysfunction after myocardial infarction. New Engl J Med 2003; 348: 1309-1321.
18. The SOLVD, Investigators. Effect of enalapril on survival in patients with reduced left ventricular ejection fractions and congestive heart failure. New Engl J Med 1991; 325: 293-302.
19. Pfeffer MA, Braunwald E, Moyé LA, Basta L, Brown EJ, Cuddy TE, Davis BR, Geltman EM, Goldman S, Flaker GC,. Effect of captopril on mortality and morbidity in patients with left ventricular dysfunction after myocardial infarction. Results of the survival and ventricular enlargement trial. The SAVE Investigators. New Engl J Med. 1992; 327: 669-677.
20. Konstam MA, Neaton JD, Dickstein K, Drexler H, Komajda M, Martinez FA, Riegger GAJ, Malbecq W, Smith RD, Guptha S, Poole-Wilson PA,. Effects of high-dose versus low-dose losartan on clinical outcomes in patients with heart failure (HEAAL study): a randomised, double-blind trial. Lancet 2009; 374: 1840-1848.
21. Packer M, Poole-Wilson PA, Armstrong PW, Cleland JG, Horowitz JD, Massie BM, Rydén L, Thygesen K, Uretsky BF,. Comparative effects of low and high doses of the angiotensin-converting enzyme inhibitor, lisinopril, on morbidity and mortality in chronic heart failure. ATLAS Study Group. Circulation 1999; 100: 2312-2318.
22. Pitt B, Pfeffer MA, Assmann SF, Boineau R, Anand IS, Claggett B, Clausell N, Desai AS, Diaz R, Fleg JL, Gordeev I, Harty B, Heitner JF, Kenwood CT, Lewis EF, O'Meara E, Probstfield JL, Shaburishvili T, Shah SJ, Solomon SD, Sweitzer NK, Yang S, McKinlay SM,. Spironolactone for heart failure with preserved ejection fraction. New Engl J Med 2014; 370: 1383-1392.
23. Lenzen MJ, Boersma E, Reimer WJMSO, Balk AHMM, Komajda M, Swedberg K, Follath F, Jimenez-Navarro M, Simoons ML, Cleland JGF,. Under-utilization of evidence-based drug treatment in patients with heart failure is only partially explained by dissimilarity to patients enrolled in landmark trials: a report from the Euro Heart Survey on Heart Failure. Eur Heart J 2005; 26: 2706-2713.
24. Peters-Klimm F, Laux G, Campbell S, Müller-Tasch T, Lossnitzer N, Schultz J-H, Remppis A, Jünger J, Nikendei C,. Physician and patient predictors of evidence-based prescribing in heart failure: a multilevel study. PloS One 2012; 7: e31082.
25. Bungard TJ, McAlister FA, Johnson JA, Tsuyuki RT,. Underutilisation of ACE inhibitors in patients with congestive heart failure. Drugs 2001; 61: 2021-2033.
26. Edep ME, Shah NB, Tateo IM, Massie BM,. Differences between primary care physicians and cardiologists in management of congestive heart failure: relation to practice guidelines. J Am Coll Cardiol 1997; 30: 518-526.
27. Echemann M, Zannad F, Briançon S, Juillière Y, Mertès PM, Virion JM, Villemot JP,. Determinants of angiotensin-converting enzyme inhibitor prescription in severe heart failure with left ventricular systolic dysfunction: the EPICAL study. Am Heart J 2000; 139: 624-631.
28. Houghton AR, Cowley AJ,. Why are angiotensin converting enzyme inhibitors underutilised in the treatment of heart failure by general practitioners? Int J Card 1997; 59: 7-10.
29. Albert NM, Yancy CW, Liang L, Zhao X, Hernandez AF, Peterson ED, Cannon CP, Fonarow GC,. Use of aldosterone antagonists in heart failure. JAMA 2009; 302: 1658-1665.
30. Maggioni AP, Anker SD, Dahlström U, Filippatos G, Ponikowski P, Zannad F, Amir O, Chioncel O, Leiro MC, Drozdz J, Erglis A, Fazlibegovic E, Fonseca C, Fruhwald F, Gatzov P, Goncalvesova E, Hassanein M, Hradec J, Kavoliuniene A, Lainscak M, Logeart D, Merkely B, Metra M, Persson H, Seferovic P, Temizhan A, Tousoulis D, Tavazzi L,. Are hospitalized or ambulatory patients with heart failure treated in accordance with European Society of Cardiology guidelines? Evidence from 12,440 patients of the ESC Heart Failure Long-Term Registry. Eur J Heart Fail 2013; 15: 1173-1184.
31. Sterns RH, Rojas M, Bernstein P, Chennupati S,. Ion-exchange resins for the treatment of hyperkalemia: are they safe and effective? J Am Soc Nephrol 2010; 21: 733-735.
32. + selective ion trap. PloS One 2014; 9: e114686.
33. Packham DK, Rasmussen HS, Lavin PT, El-Shahawy MA, Roger SD, Block G, Qunibi W, Pergola P, Singh B,. Sodium zirconium cyclosilicate in hyperkalemia. New Engl J Med 2014; 372: 222-231.
34. Kosiborod M, Rasmussen HS, Lavin P, Qunibi WY, Spinowitz B, Packham D, Roger SD, Yang A, Lerma E, Singh B,. Effect of sodium zirconium cyclosilicate on potassium lowering for 28 days among outpatients with hyperkalemia. JAMA 2014; 312: 2223-2233.