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. 2023 Jun 21:10:20543581231172405.
doi: 10.1177/20543581231172405. eCollection 2023.

Adverse Gastrointestinal Events With Sodium Polystyrene Sulfonate Use in Patients on Maintenance Hemodialysis: An International Cohort Study

Ana Cecilia Farfan Ruiz  1 , Ranjeeta Malick  1 , Emily Rhodes  1   2 , Edward Clark  1 , Greg Hundemer  1 , Angelo Karaboyas  3 , Bruce Robinson  3 , Roberto Pecoits  3 , Manish M Sood  1
Affiliations

Adverse Gastrointestinal Events With Sodium Polystyrene Sulfonate Use in Patients on Maintenance Hemodialysis: An International Cohort Study

Ana Cecilia Farfan Ruiz et al. Can J Kidney Health Dis. .

Abstract
in English, French

Background: There are concerns regarding the gastrointestinal (GI) safety of sodium polystyrene sulfonate (SPS), a medication commonly used in the management of hyperkalemia.

Objective: To compare the risk of GI adverse events among users versus non-users of SPS in patients on maintenance hemodialysis.

Design: International prospective cohort study.

Setting: Seventeen countries (Dialysis Outcomes and Practice Patterns Study [DOPPS] phase 2-6 from 2002 to 2018).

Patients: 50 147 adults on maintenance hemodialysis.

Measurements: An adverse GI event defined by a GI hospitalization or GI fatality with SPS prescription compared with no SPS prescription.

Methods: Overlap propensity score-weighted Cox models.

Results: Sodium polystyrene sulfonate prescription was present in 13.4% of patients and ranged from 0.42% (Turkey) to 20.6% (Sweden) with 12.5% use in Canada. A total of 935 (1.9%) adverse GI events (140 [2.1%] with SPS, 795 [1.9%] with no SPS; absolute risk difference 0.2%) occurred. The weighted hazard ratio (HR) of a GI event was not elevated with SPS use compared with non-use (HR = 0.93, 95% confidence interval = 0.83-1.6). The results were consistent when examining fatal GI events and/or GI hospitalization separately.

Limitations: Sodium polystyrene sulfonate dose and duration were unknown.

Conclusions: Sodium polystyrene sulfonate use in patients on hemodialysis was not associated with a higher risk of an adverse GI event. Our findings suggest that SPS use is safe in an international cohort of maintenance hemodialysis patients.

Contexte: Des préoccupations sont soulevées quant à l’innocuité gastro-intestinale (GI) du sulfonate de polystyrène sodique (SPS), un médicament couramment utilisé dans la gestion de l’hyperkaliémie.

Objectif: Comparer dans une population de patients sous hémodialyse d’entretien le risque d’effets indésirables gastro-intestinaux chez les utilisateurs du SPS par rapport aux patients non-utilisateurs.

Conception: Étude de cohorte prospective internationale.

Cadre: 17 pays (phases 2 à 6 de l’essai DOPPS [de 2002 à 2018]).

Sujets: 50 147 adultes sous hémodialyse d’entretien.

Mesures: La comparaison entre les événements gastro-intestinaux indésirables, définis par une hospitalisation ou un décès en lien avec un problème gastro-intestinal, selon que les patients avaient ou non une prescription de SPS.

Méthodologie: Modèles de Cox pondérés par le score de propension au chevauchement.

Résultats: Dans l’ensemble de la cohorte, 13,4 % des patients avaient une prescription de SPS; l’usage de SPS variait selon les pays entre 0,42 % (Turquie) et 20,6 % (Suède) avec 12,5 % au Canada. En tout, 935 (1,9 %) événements GI indésirables sont survenus dans l’ensemble de la cohorte, soit 140 (2,1 %) chez les patients avec prescription de SPS et 795 (1,9 %) chez les patients sans prescription de SPS (différence de risque absolue: 0,2 %). Le rapport de risque (RR) pondéré d’un événement GI n’était pas plus élevé avec l’utilisation de SPS (RR = 0,93; IC 95 %: 0,83-1,6). Les résultats étaient cohérents lorsque l’on a examiné séparément les événements gastro-intestinaux (hospitalisation et/ou décès).

Limites: La dose et la durée du traitement par SPS étaient inconnues.

Conclusion: L’utilisation de SPS chez les patients sous hémodialyse n’a pas été associée à un risque plus élevé d’événements indésirables d’origine gastro-intestinale. Nos résultats suggèrent que l’utilisation du SPS est sans danger dans la cohorte internationale de patients sous hémodialyse d’entretien étudiée.

Keywords: DOPPS; SPS; gastrointestinal events; hemodialysis; hyperkalemia; international.

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Conflict of interest statement

The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: M.M.S. has received a speaker fee from AstraZeneca. All other authors declare that they have no relevant financial interests.

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