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

• Published in: Nephrology, dialysis, transplantation dialysis, transplantation, 2020-09, Vol.35 (9), p.1518-1526
• Main Authors: Laureati, Paola, Xu, Yang, Trevisan, Marco, Schalin, Lovisa, Mariani, Illaria, Bellocco, Rino, Sood, Manish M, Barany, Peter, Sjölander, Arvid, Evans, Marie, Carrero, Juan J
• Format: Article
• Language: English
• Subjects: Aged; Aged, 80 and over; Female; Gastrointestinal Diseases - chemically induced; Gastrointestinal Diseases - epidemiology; Gastrointestinal Diseases - pathology; Humans; Incidence; Male; Medicin och hälsovetenskap; Middle Aged; ORIGINAL ARTICLES; Polystyrenes - adverse effects; Renal Insufficiency, Chronic - drug therapy; Renal Insufficiency, Chronic - pathology; Retrospective Studies; Risk Factors; Sweden - epidemiology
• ISSN: 0931-0509; 1460-2385; 1460-2385
• DOI: 10.1093/ndt/gfz150

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.