Risks and Benefits of Sodium Polystyrene Sulfonate for Hyperkalemia in Patients on Maintenance Hemodialysis

Nakamura, Teruko; Fujisaki, Taisei; Miyazono, Motoaki; Yoshihara, Maki; Jinnouchi, Hiroshi; Fukunari, Kenichi; Awanami, Yuki; Ikeda, Yuki; Hashimoto, Kohei; Yamasaki, M.; Nonaka, Yasunori; Fukuda, Makoto; Kishi, Tomoya; Ikeda, Yûji

doi:10.1007/s40268-018-0244-x

Cited by 9 publications

(11 citation statements)

References 11 publications

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“…SPS exhibits an advantage over CPS because a smaller amount is sufficient to treat hyperkalemia (5–15 g/day). However, if a higher-dose ion-exchange resin is required, physicians should select the type and amount of resin according to the sodium and/or calcium load [ 41 ]. Serious gastrointestinal complications from SPS, given with and without sorbitol, have been reported, including fatal colonic perforation and mortality being up to 33% [ 42 ].…”

Section: Hyperkalemia In Dialysis Patientsmentioning

confidence: 99%

Management of hyperkalemia in patients with kidney disease: a position paper endorsed by the Italian Society of Nephrology

Bianchi

Aucella

Nicola³

et al. 2019

J Nephrol

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Hyperkalemia (HK) is the most common electrolyte disturbance observed in patients with kidney disease, particularly in those in whom diabetes and heart failure are present or are on treatment with renin-angiotensin-aldosterone system inhibitors (RAASIs). HK is recognised as a major risk of potentially life threatening cardiac arrhythmic complications. When an acute reduction of renal function manifests, both in patients with chronic kidney disease (CKD) and in those with previously normal renal function, HK is the main indication for the execution of urgent medical treatment and the recourse to extracorporeal replacement therapies. In patients with end-stage renal disease, the presence of HK not responsive to medical therapy is an indication at the beginning of chronic renal replacement therapy. HK can also be associated indirectly with the progression of CKD, because the finding of high potassium values leads to withdrawal of treatment with RAASIs, which constitute the first choice nephro-protective treatment. It is therefore essential to identify patients at risk of developing HK, and to implement therapeutic interventions aimed at preventing and treating this dangerous complication of kidney disease. Current strategies aimed at the prevention and treatment of HK are still unsatisfactory, as evidenced by the relatively high prevalence of HK also in patients under stable nephrology care, and even in the ideal setting of randomized clinical trials where optimal treatment and monitoring are mandatory. This position paper will review the main therapeutic interventions to be implemented for the prevention, detection and treatment of HK in patients with CKD on conservative care, in those on dialysis, in patients in whom renal disease is associated with diabetes, heart failure, resistant hypertension and who are on treatment with RAASIs, and finally in those presenting with severe acute HK.

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Section: Hyperkalemia In Dialysis Patientsmentioning

confidence: 99%

Management of hyperkalemia in patients with kidney disease: a position paper endorsed by the Italian Society of Nephrology

Bianchi

Aucella

Nicola³

et al. 2019

J Nephrol

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“…Options for managing hyperkalemia in Japan are limited, relying on dietary restrictions, cessation or modification of inciting agents, and potassium elimination with non-specific exchange resins, e.g., sodium polystyrene sulfonate (SPS) and calcium polystyrene sulfonate (CPS) [ 11 , 12 ]. Although SPS and CPS have been widely used for several decades, their efficacy and safety have been questioned [ 13 – 16 ].…”

Section: Introductionmentioning

confidence: 99%

Correction of serum potassium with sodium zirconium cyclosilicate in Japanese patients with hyperkalemia: a randomized, dose–response, phase 2/3 study

Kashihara

Nishio²,

Osonoi

et al. 2020

Clin Exp Nephrol

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Background Sodium zirconium cyclosilicate (SZC) is an oral potassium binder approved to treat hyperkalemia in adults in a number of countries, including Japan. Methods This phase 2/3, randomized, double-blind, placebo-controlled, dose–response study (ClinicalTrials.gov: NCT03127644) was designed to determine the efficacy and safety of SZC in Japanese adults with hyperkalemia. Patients with serum potassium (sK+) concentrations ≥ 5.1– ≤ 6.5 mmol/L were randomized 1:1:1 to SZC 5 g, SZC 10 g, or placebo three times daily for 48 h (six doses total). The primary efficacy endpoint was the exponential rate of change in sK+ over 48 h. The proportion of patients with normokalemia (sK+ 3.5–5.0 mmol/L) at 48 h and adverse events (AEs) were also evaluated. Results Overall, 103 patients (mean age, 73.2 years; range 50–89 years) received SZC 5 g (n = 34), SZC 10 g (n = 36), or placebo (n = 33). The exponential rate of sK+ change from 0 to 48 h versus placebo was − 0.00261 (SZC 5 g) and – 0.00496 (SZC 10 g; both P < 0.0001). At 48 h, the proportions of patients with normokalemia were 85.3%, 91.7%, and 15.2% with SZC 5 g, SZC 10 g, and placebo, respectively. No serious AEs were reported. Hypokalemia (sK+ < 3.5 mmol/L) occurred in two patients in the SZC 10 g group; normokalemia was re-established within 6 days and no treatment-related AEs were reported. Conclusion SZC is effective and well tolerated in Japanese patients with hyperkalemia.

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“…After applying the exclusion criteria and removal of duplicates, 30 articles were eligible for inclusion ( Table 1 ). 10 , 12 , 15 , 28 - 54 Of the included studies, 4 studies were RCTs, 21 were observational studies ( Table 2 ), and 5 studies were nonrandomized interventional study designs (quasi-experimental study designs) ( Table 3 ). Most of the literature was published since 2010: 4 articles were published before 1990, 1 between 1990 and 2000, 3 between 2000 and 2010, and 22 were published since 2010.…”

Section: Resultsmentioning

confidence: 99%

Polysulfonate Resins in Hyperkalemia: A Systematic Review

Wong

Zhang

Norman³

et al. 2020

Can J Kidney Health Dis

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Background: Hyperkalemia is a potentially life-threatening electrolyte abnormality defined as a serum potassium above the lab reference range (usually >5.0-5.5 mEq/L). Polystyrene resins, including sodium polystyrene sulfonate (SPS) and calcium polystyrene sulfonate (CPS), have long been used to treat hyperkalemia. Sodium polystyrene sulfonate/calcium polystyrene sulfonate act by exchanging a cation for potassium within the intestinal lumen. While SPS and CPS have been available since the 1960s, there are rising concerns about the validity of the data supporting its use and about serious adverse gastrointestinal effects. Objective: The objective of this systematic review was to quantify the efficacy and safety of polystyrene sulfonate resins (SPS/CPS) in the treatment of adults with hyperkalemia. This review focuses on the randomized control trial (RCT), interventional non-RCT, and observational data available on SPS/CPS use. Design: Systematic review. Setting: Any country of origin. Both inpatient and outpatient settings. Patients: Adults with hyperkalemia treated with polystyrene sulfonate resins. Measurements: The primary outcome was change in serum potassium. The secondary outcomes included adverse effects of SPS/CPS and prevention of recurrent hyperkalemia. Methods: We conducted a systematic review using Cochrane Library, EMBASE (1947-2019), and Medline (1946-2019) databases. Literature reviews, systematic reviews, case studies, case series, and editorial pieces were excluded. Included studies were assessed for risk of bias. Results: Four RCTs, 21 observational studies, and 5 quasi-experimental trials were included. A total of 212 351 patients were included. Two thousand and fifty-eight patients were studied for the primary outcome and 210 293 patients were studied for the secondary outcomes. Study designs were heterogeneous and not amenable to meta-analysis. Most studies included nonhemodialysis outpatients older than 65 years. Of the included studies, 22/25 (88%) demonstrated a reduction of serum potassium >0.5 mEq/L over the study period. The magnitude of reduction in serum potassium of potassium resin compared with placebo or matched controls in the 3 low-risk studies identified was 0.14 to 1.04 mEq/L. However, each study used different dosing regimens. Ten of 22 studies reported the effects of polystyrene resins on serum potassium within 24 hours. A few high-quality observational studies suggest an increased risk of serious adverse gastrointestinal events with a relative risk of 2.10 and a hazard ratio of 1.25 to 1.94; however, the absolute risk remains low. The incidence of adverse gastrointestinal events is 16 to 23 events per 1000 person-years. Limitations: We acknowledge several limitations in this study. Case studies and case series were excluded from the search results. Large case series may have been excluded despite having comparable sample sizes to studies included due to lack of a comparator and calculated estimates. Due to the heterogeneity of the studies, the data were unable to be meta-analyzed and as such the potassium-lowering effect of polystyrene sulfonate resins remains founded on small studies with potential confounders. Conclusions: This systematic review demonstrates a continued lack of high-quality evidence for the use of SPS/CPS in hyperkalemia. Studies investigated highly variable timelines and the most robust evidence for SPS/CPS use is in chronic hyperkalemia. While the absence of high-quality evidence does not exclude the possibility of benefit, prescribers must understand that the use of SPS/CPS in acute hyperkalemia is not supported by high-quality evidence. Trial registration: The protocol for this systematic review was not registered.

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Risks and Benefits of Sodium Polystyrene Sulfonate for Hyperkalemia in Patients on Maintenance Hemodialysis

Cited by 9 publications

References 11 publications

Management of hyperkalemia in patients with kidney disease: a position paper endorsed by the Italian Society of Nephrology

Management of hyperkalemia in patients with kidney disease: a position paper endorsed by the Italian Society of Nephrology

Correction of serum potassium with sodium zirconium cyclosilicate in Japanese patients with hyperkalemia: a randomized, dose–response, phase 2/3 study

Polysulfonate Resins in Hyperkalemia: A Systematic Review

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