Risk of Intestinal Necrosis With Sodium Polystyrene Sulfonate: A Systematic Review and Meta-analysis.

Background: Reports of severe gastrointestinal side effects associated with sodium polystyrene sulfonate (SPS), particularly intestinal necrosis, have led some to recommend costlier alternative medications. No prior systematic review has included studies with controls reporting intestinal necrosis rates associated with SPS.

Methods: A systematic literature search was conducted using Cochrane Library, Embase, Medline, Google Scholar, PubMed, Scopus, and Web of Science Core Collection from database inception through October 4, 2020. We included any clinical trial, cohort, or case-control study reporting an association between SPS and intestinal necrosis or severe gastrointestinal side effects.

Results: Six studies including 26,716 patients treated with SPS with controls met inclusion criteria. The pooled odds ratio (OR) of intestinal necrosis was 1.43 (95% CI, 0.39-5.20). The pooled hazard ratio (HR) for intestinal necrosis from the two studies that performed survival analysis was 2.00 (95% CI, 0.45-8.78). The pooled HR for the composite outcome of severe gastrointestinal adverse events was 1.46 (95% CI, 1.01-2.11).

Conclusion: Based on our review of six studies, the risk of intestinal necrosis with SPS is not statistically greater than controls, although there was a statistically significantly increased risk for the composite outcome of severe gastrointestinal side effects based on two studies. Because of the risk of bias from potential confounding and selective reporting, the overall strength of evidence to support an association between SPS and intestinal necrosis or other severe gastrointestinal side effects is low. PROSPERO registration CRD42020213119.