Efficacy and safety of the pharmacotherapy used in the management of hyperkalemia: a systematic review
Main Article Content
Keywords
Abstract
Background: Although the management of hyperkalemia follows expert guidelines, treatment approaches are based on traditionally accepted practice standards. New drugs have been assessed such as sodium zirconium cyclosilicate and patiromer; however, their safety and efficacy or effectiveness have not yet been compared to traditional pharmacotherapy.
Objective: The present systematic review had the purpose to evaluate the efficacy, effectiveness, and safety of hyperkalemia pharmacotherapies.
Methods: PubMed, LILACS, Cochrane Library, and ClinicalTrials were searched through November 2018. Clinical trial, cohort and case-control were searched. The risk of bias (RoB v2.0 and ROBINS-I) and quality of evidence (GRADE) at the level of outcomes were assessed.
Results: Sixteen clinical trials and one retrospective cohort were identified regarding efficacy and safety of 24 different alternatives. The management of hyperkalemia remains empirical and off-label, since sodium zirconium cyclosilicate and patiromer are not available in several countries and further studies are required to assess efficacy, effectiveness and safety. Sodium or calcium polystyrene sulfonate (moderate confidence), sodium zirconium cyclosilicate (moderate confidence), and insulin plus dextrose (moderate confidence) showed superior efficacy to, respectively, placebo, no treatment, placebo, and dextrose. Other therapies (low confidence) showed similar efficacy compared to active or inactive alternatives. Most of the adverse events reported were nonspecific, so it was not possible to assign the cause and to classify as defined or probable.
Conclusions: Comparative cohort and case-control studies are need to evaluate the safety and effectiveness of new and traditional pharmacotherapies to support the development of guidelines about acute and chronic hyperkalemia, with high-quality evidence.
References
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2. Cada DJ, Dang J, Baker DE. Patiromer. Hosp Pharm. 2016;51(4):328-336. https://dx.doi.org/10.1310/hpj5104-328
3. Lazich I, Bakris GL. Prediction and Management of Hyperkalemia across the Spectrum of Chronic Kidney Disease. Semin Nephrol. 2014;34(3):333-339. https://dx.doi.org/10.1016/j.semnephrol.2014.04.008
4. Kovesdy CP. Updates in hyperkalemia: Outcomes and therapeutic strategies. Rev Endocr Metab Disord. 2017;18(1):41-47. https://dx.doi.org/10.1007/s11154-016-9384-x
5. Palmer BF. Managing hyperkalemia caused by inhibitors of the renin-angiotensin-aldosterone system. N Engl J Med. 2004;351(6):585-592. https://dx.doi.org/10.1056/NEJMra035279
6. Sterns RH, Grieff M, Bernstein PL. Treatment of hyperkalemia: something old, something new. Kidney Int. 2016;89(3):546-554. https://dx.doi.org/10.1016/j.kint.2015.11.018
7. Georgianos PI, Liampas I, Kyriakou A, Vaios V, Raptis V, Savvidis N, Sioulis A, Liakopoulos V, Balaskas EV, Zebekakis PE. Evaluation of the tolerability and efficacy of sodium polystyrene sulfonate for long-term management of hyperkalemia in patients with chronic kidney disease. Int Urol Nephrol. 2017;49(12):2217-2221. https://dx.doi.org/10.1007/s11255-017-1717-5
8. 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(3):264.e9-e24. https://dx.doi.org/10.1016/j.amjmed.2012.08.016
9. Rozich JD, Haraden CR, Resar RK. Adverse drug event trigger tool: a practical methodology for measuring medication related harm. Qual Saf Health Care. 2003;12(3):194-200.
10. Palaka E, Leonard S, Buchanan-Hughes A, Bobrowska A, Langford B, Grandy S. Evidence in support of hyperkalaemia management strategies: A systematic literature review. Int J Clin Pract. 2018;72(2). https://dx.doi.org/10.1111/ijcp.13052
11. Meaney CJ, Beccari M V, Yang Y, Zhao J. Systematic review and meta-analysis of patiromer and sodium zirconium cyclosilicate: a new armamentarium for the treatment of hyperkalemia. Pharmacotherapy. 2017;37(4):401-411. https://dx.doi.org/10.1002/phar.1906
12. Das S, Dey JK, Sen S, Mukherjee R. Efficacy and safety of patiromer in hyperkalemia: a systematic review and meta-analysis. J Pharm Pract. 2018;31(1):6-17. https://dx.doi.org/10.1177/0897190017692921
13. Montford JR, Linas S. How Dangerous Is Hyperkalemia? J Am Soc Nephrol. 2017;28(11):3155-3165. https://dx.doi.org/10.1681/ASN.2016121344
14. Rossignol P, Legrand M, Kosiborod M, Hollenberg SM, Peacock WF, Emmett M, Epstein M7, Kovesdy CP, Yilmaz MB, Stough WG, Gayat E, Pitt B, Zannad F, Mebazaa A. Emergency management of severe hyperkalemia: Guideline for best practice and opportunities for the future. Pharmacol Res. 2016;113(Pt A):585-591. https://dx.doi.org/10.1016/j.phrs.2016.09.039
15. Moher D, Liberati A, Tetzlaff J, Altman DG. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. PLoS Med. 2009;6(7):e1000097. https://dx.doi.org/10.1371/journal.pmed.1000097
16. McGowan J, Sampson M, Salzwedel DM, Cogo E, Foerster V, Lefebvre C. PRESS Peer Review of Electronic Search Strategies: 2015 Guideline Statement. J Clin Epidemiol. 2016;75:40-6. https://dx.doi.org/10.1016/j.jclinepi.2016.01.021
17. Trombotto V, Mastroianni P, Varallo F, Lucchetta R. Efficacy and safety of hyperkalemia therapy: systematic review and meta-analysis. PROSPERO. 2017;CRD4201705. Available at: https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=50710 (accessed Aug 31, 2018).
18. Batterink J, Cessford TA, Taylor RA. Pharmacological interventions for the acute management of hyperkalaemia in adults. Cochrane Database Syst Rev. 2015;27(10):CD010344. https://dx.doi.org/10.1002/14651858.CD010344.pub2
19. Mahoney BA, Smith WAD, Lo DS, Tsoi K, Tonelli M, Clase CM. Emergency interventions for hyperkalaemia. Cochrane database Syst Rev. 2005;(2):CD003235. https://dx.doi.org/10.1002/14651858.CD003235.pub2
20. Higgins JPT, Sterne JAC, Savović J, Page MJ, Hróbjartsson A, Boutron I, Reeves B, Eldridge S. A revised tool for assessing risk of bias in randomized trials In: Chandler J, McKenzie J, Boutron I, Welch V (editors). Cochrane Methods. Cochrane Database of Systematic Reviews 2016, Issue 10 (Suppl 1). https://dx.doi.org/10.1002/14651858.CD201601
21. Sterne JA, et al. ROBINS-I: a tool for assessing risk of bias in non-randomised studies of interventions. BMJ. 2016;355:i4919. https://dx.doi.org/10.1136/bmj.i4919
22. Atkins D, et al. Grading quality of evidence and strength of recommendations. BMJ. 2004;328(7454):1490. https://dx.doi.org/10.1136/bmj.328.7454.1490
23. Oschman A, Gansen A, Kilbride H, Sandritter T. Safety and efficacy of two potassium cocktail formulations for treatment of neonatal hyperkalemia. Ann Pharmacother. 2011;45(11):1371-7. https://dx.doi.org/10.1345/aph.1Q292
24. Lens XM, Montoliu J, Cases A, Campistol JM, Revert L. Treatment of hyperkalaemia in renal failure: salbutamol v. insulin. Nephrol Dial Transplant. 1989;4(3):228-232.
25. Ngugi NN, McLigeyo SO, Kayima JK. Treatment of hyperkalaemia by altering the transcellular gradient in patients with renal failure: effect of various therapeutic approaches. East Afr Med J. 1997;74(8):503-509.
26. Singh BS, Sadiq HF, Noguchi A, Keenan WJ. Efficacy of albuterol inhalation in treatment of hyperkalemia in premature neonates. J Pediatr. 2002;141(1):16-20.
27. Mushtaq M, Masood M. Treatment of hyperkalemia with salbutamol and insulin. Pak J Med Sci. 2006;22(2):176-179.
28. Chothia M-Y, Halperin ML, Rensburg MA, Hassan MS, Davids MR. Bolus administration of intravenous glucose in the treatment of hyperkalemia: a randomized controlled trial. Nephron Physiol. 2014;126(1):1-8. https://dx.doi.org/10.1159/000358836
29. Ramos-Peñafiel CO, Tovilla-Ruiz CK, Galván-Flores F, Castañeda-Rodríguez R, Espinoza MÁÁ, Durán-Guzmán R, et al. Eficacia de hiperK-cocktail vs insulina regular en el tratamiento de la hipercalemia. Med Interna Mex. 2015;31(1):50-56.
30. Saw HP, Chiu CD, Chiu YP, Ji HR, Chen JY. Nebulized salbutamol diminish the blood glucose fluctuation in the treatment of non-oliguric hyperkalemia of premature infants. J Chin Med Assoc. 2018 [Epub ahead of print]. https://dx.doi.org/10.1016/j.jcma.2018.04.002
31. Nasir K, Ahmad A. Treatment of hyperkalemia in patients with chronic kidney disease: a comparison of calcium polystyrene sulphonate and sodium polystyrene sulphonate. J Ayub Med Coll Abbottabad. 2014;26(4):455-458.
32. Lepage L, Dufour A-C, Doiron J, Handfield K, Desforges K, Bell R, Vallée M, Savoie M, Perreault S, Laurin LP, Pichette V, Lafrance JP. Randomized Clinical Trial of Sodium Polystyrene Sulfonate for the Treatment of Mild Hyperkalemia in CKD. Clin J Am Soc Nephrol. 2015;10(12):2136-42. https://dx.doi.org/10.2215/CJN.03640415
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. N Engl J Med. 2015;372(3):222-231. https://dx.doi.org/10.1056/NEJMoa1411487
34. Ash SR, Singh B, Lavin PT, Stavros F, Rasmussen HS. 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(2):404-411. https://dx.doi.org/10.1038/ki.2014.382
35. Kaisar MO, Wiggins KJ, Sturtevant JM, Hawley CM, Campbell SB, Isbel NM, Mudge DW, Bofinger A, Petrie JJ, Johnson DW. A randomized controlled trial of fludrocortisone for the treatment of hyperkalemia in hemodialysis patients. Am J Kidney Dis. 2006;47(5):809-814. https://dx.doi.org/10.1053/j.ajkd.2006.01.014
36. Kim D-M, Chung JH, Yoon SH, Kim HL. Effect of fludrocortisone acetate on reducing serum potassium levels in patients with end-stage renal disease undergoing haemodialysis. Nephrol Dial Transplant. 2007;22(11):3273-3276. https://dx.doi.org/10.1093/ndt/gfm386
37. Nakayama Y, Ueda K, Yamagishi S-I, Sugiyama M, Yoshida C, Kurokawa Y, Nakamura N, Moriyama T, Kodama G, Minezaki T, Ito S, Nagata A, Taguchi K, Yano J, Kaida Y, Shibatomi K, Fukami K. Compared effects of calcium and sodium polystyrene sulfonate on mineral and bone metabolism and volume overload in pre-dialysis patients with hyperkalemia. Clin Exp Nephrol. 2018;22(1):35-44. https://dx.doi.org/10.1007/s10157-017-1412-y
38. Wang J, Lv MM, Zach O, Wang LY, Zhou MY, Song GR, Zhang X, Lin HL. Calcium-polystyrene sulfonate decreases inter-dialytic hyperkalemia in patients undergoing maintenance hemodialysis: a prospective, randomized, crossover study. Ther Apher Dial. 2018;22(6):609-616. https://dx.doi.org/10.1111/1744-9987.12723
39. Kerr PC, Cowie RI. Acquired deafness: a multi-dimensional experience. Br J Audiol. 1997;31(3):177-188.
40. De Nicola L, Di Lullo L, Paoletti E, Cupisti A, Bianchi S. Chronic hyperkalemia in non-dialysis CKD: controversial issues in nephrology practice. J Nephrol. 2018;31(5):653-664. https://dx.doi.org/10.1007/s40620-018-0502-6
41. Rafique Z, Peacock WF, LoVecchio F, Levy PD. Sodium zirconium cyclosilicate (ZS-9) for the treatment of hyperkalemia. Expert Opin Pharmacother. 2015;16(11):1727-1734. https://dx.doi.org/10.1517/14656566.2015.1066334
42. Driver BE, Klein LR, Chittineni C, Cales EK, Scott N. Is transcellular potassium shifting with insulin, albuterol, or sodium bicarbonate in emergency department patients with hyperkalemia associated with recurrent hyperkalemia after dialysis? J Emerg Med. 2018;55(1):15-22. https://dx.doi.org/10.1016/j.jemermed.2018.02.012
43. Sarafidis PA, Georgianos PI, Bakris GL. Advances in treatment of hyperkalemia in chronic kidney disease. Expert Opin Pharmacother. 2015;16(14):2205-2215. https://dx.doi.org/10.1517/14656566.2015.1083977
44. 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(3):264.e9-e24. https://dx.doi.org/10.1016/j.amjmed.2012.08.016
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Efficacy and safety of the pharmacotherapy used in the management of hyperkalemia: a systematic review. Pharm Pract (Granada) [Internet]. 2019 Mar. 4 [cited 2024 Dec. 2];17(1):1361. Available from: https://www.pharmacypractice.org/index.php/pp/article/view/1361
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How to Cite
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Efficacy and safety of the pharmacotherapy used in the management of hyperkalemia: a systematic review. Pharm Pract (Granada) [Internet]. 2019 Mar. 4 [cited 2024 Dec. 2];17(1):1361. Available from: https://www.pharmacypractice.org/index.php/pp/article/view/1361