Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Observational Study
. 2020 Sep 1;35(9):1518-1526.
doi: 10.1093/ndt/gfz150.

Initiation of sodium polystyrene sulphonate and the risk of gastrointestinal adverse events in advanced chronic kidney disease: a nationwide study

Paola Laureati  1   2 , Yang Xu  1 , Marco Trevisan  1 , Lovisa Schalin  3 , Illaria Mariani  1   2 , Rino Bellocco  1   2 , Manish M Sood  4 , Peter Barany  5 , Arvid Sjölander  1 , Marie Evans  5 , Juan J Carrero  1
Affiliations
Observational Study

Initiation of sodium polystyrene sulphonate and the risk of gastrointestinal adverse events in advanced chronic kidney disease: a nationwide study

Paola Laureati et al. Nephrol Dial Transplant. .

Abstract

Background: Despite long-standing clinical use of sodium polystyrene sulphonate (SPS) for hyperkalaemia management in chronic kidney disease (CKD), its safety profile remains poorly investigated.

Methods: We undertook an observational analysis of nephrology-referred adults with incident CKD Stage 4+ in Sweden during 2006-16 and with no previous SPS use. We studied patterns of use and adverse events associated to SPS initiation during follow-up. Patterns of SPS use were defined by chronicity of treatment and by prescribed dose. We estimated hazard ratios (HRs) and 95% confidence intervals (CIs) associated with SPS initiation (time-varying exposure) for the risk of severe (intestinal ischaemia, thrombosis or ulceration/perforation) and minor (de novo dispensation of laxatives or anti-diarrheal drugs) gastrointestinal (GI) events.

Results: Of 19 530 SPS-naïve patients with CKD, 3690 initiated SPS during follow-up. A total of 59% took SPS chronically, with an average of three dispensations/year. The majority (85%) were prescribed lower dosages than specified on the product label. During follow-up, 202 severe and 1149 minor GI events were recorded. SPS initiation was associated with a higher incidence of severe adverse events [adjusted HR 1.25 95% CI 1.05-1.49)], particularly in those receiving per label doses [1.54 (1.09-2.17)] and mainly attributed to ulcers and perforations. SPS initiation was also associated with higher incidence of minor GI events [adjusted HR 1.11 (95% CI 1.03-1.19)], regardless of dose, and mainly accounted for by de novo dispensation of laxatives.

Conclusions: Initiation of SPS in patients with advanced CKD is associated with a higher risk of severe GI complications as well as the initiation of GI-related medications, particularly when prescribed at per label doses.

Keywords: CKD; chronic haemodialysis; chronic renal failure; epidemiology; hyperkalaemia.

PubMed Disclaimer

Figures

FIGURE 1
FIGURE 1
Flow chart of patient selection to the study.
FIGURE 2
FIGURE 2
Distribution of (A) the number of days between the first and second SPS dispensation and (B) the percentage of patients dispensing a single SPS package or receiving chronic treatment, as well as dosages used. In (A), the dashed line represents the median number of days between dispensations, which was 70 days.
FIGURE 3
FIGURE 3
Forest plot for the severe and minor GI adverse events associated with SPS initiation in advanced CKD.
See this image and copyright information in PMC

Comment in

References

    1. Gasparini A, Evans M, Barany P. et al. Plasma potassium ranges associated with mortality across stages of chronic kidney disease: the Stockholm CREAtinine Measurements (SCREAM) project. Nephrol Dial Transplant 2019; 34: 1534–1541 - PMC - PubMed
    1. Kovesdy CP, Matsushita K, Sang Y. et al. Serum potassium and adverse outcomes across the range of kidney function: a CKD Prognosis Consortium meta-analysis. Eur Heart J 2018; 39: 1535–1542 - PMC - PubMed
    1. Nilsson E, Gasparini A, Arnlov J. et al. Incidence and determinants of hyperkalemia and hypokalemia in a large healthcare system. Int J Cardiol 2017; 245: 277–284 - PubMed
    1. Kovesdy CP, Appel LJ, Grams ME. et al. Potassium homeostasis in health and disease: a scientific workshop cosponsored by the National Kidney Foundation and the American Society of Hypertension. Am J Kidney Dis 2017; 70: 844–858 - PubMed
    1. 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

Publication types