Administration of sodium polystyrene sulfonate, commonly prescribed for hyperkalemia, is associated with adverse gastrointestinal (GI) events and hospitalization in elderly patients, show the results of a study published in JAMA.
Case reports of intestinal injury after administration of sodium polystyrene sulfonate with sorbitol resulted in a US Food and Drug Administration (FDA) warning and discontinuation of combined 70% sorbitol–sodium polystyrene sulfonate formulations. There are ongoing concerns about the gastrointestinal (GI) safety of sodium polystyrene sulfonate use.
The study was conducted to investigate the risk of hospitalization for adverse GI events associated with sodium polystyrene sulfonate use in patients of advanced age.
The researchers conducted a population-based, retrospective matched cohort study of eligible adults of advanced age (≥66 years) dispensed sodium polystyrene sulfonate from April 1, 2003, to September 30, 2015, in Ontario, Canada, with maximum follow-up to March 31, 2016. Initial data analysis was conducted from August 1, 2018, to October 3, 2018; revision analysis was conducted from February 25, 2019, to April 2, 2019. Cox proportional hazards regression models were used to examining the association of sodium polystyrene sulfonate use with a composite of GI adverse events compared with nonuse that was matched via a high-dimensional propensity score. Additional analyses were limited to a subpopulation with baseline laboratory values of estimated glomerular filtration rate and serum potassium level.
The primary outcome was a composite of adverse GI events (hospitalization or emergency department visit with intestinal ischemia/thrombosis, GI ulceration/perforation, or resection/ostomy) within 30 days of initial sodium polystyrene sulfonate prescription.
Key finding of the study
- From a total of 1 853 866 eligible adults, 27 704 individuals were dispensed sodium polystyrene sulfonate, and 20 020 sodium polystyrene sulfonate users were matched to 20 020 nonusers.
- Sodium polystyrene sulfonate use compared with nonuse was associated with a higher risk of an adverse GI event over the following 30 days in 37 events; the incidence rate was, 22.97 per 1000 person-years whereas the incidence was comparatively low in the group with nonuse.
- Results were consistent in additional analyses, including the subpopulation with baseline laboratory values, and intestinal ischemia/thrombosis was the most common type of GI injury.
The authors concluded that the use of sodium polystyrene sulfonate is associated with a higher risk of hospitalization for serious adverse GI events. They added that these findings require confirmation and suggest caution with the ongoing use of sodium polystyrene sulfonate.
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