Adverse gastrointestinal events with sodium polystyrene sulphonate and calcium polystyrene sulphonate use in dialysis patients: a nationwide registry study

Abstract

Introduction: Sodium polystyrene sulphonate (SPS) and calcium polystyrene sulphonate (CPS) are commonly used cation-exchange resins for the treatment and control of hyperkalaemia. However, their use (particularly SPS) has been limited by reports of adverse gastrointestinal (GI) events. The safety of these compounds in patients undergoing dialysis requires larger investigation.

Aims: To study the occurrence of adverse GI events (occlusion, perforation, thrombosis/ischaemia) in the periods of SPS or CPS exposition versus the periods without exposition in dialysis patients.

Methods: Dialysis patients were extracted from the French National Registry and merged with the French hospital discharge database (between 2006 and 2017). For our primary analysis, we used patients who had any claim of SPS use (n = 43 771). Time-varying Cox models, negative binomial regression and pre- versus post-treatment average treatment effects.

Results: The mean age was 66 ± 15 years, 37% were female and 92% were undergoing haemodialysis. Over a 1-year follow-up, patients on periods with SPS (on-SPS) did not present an increased risk of adverse GI events versus the periods without SPS (off-SPS): incidence rate (IR) (per 1000 person years) = 7.4 (6.4-8.7) versus 9.5 (8.1-11.0); adjusted hazard ratio (HR) (95% CI) = 0.81 (0.60-1.09), P = 0.17. Patients exposed to SPS did not experience a higher rate of adverse GI events in the year after SPS initiation versus the year before SPS initiation; P-value for parallel trend = 0.87. Patients on-CPS also did not show an increased risk of adverse GI events versus off-CPS: IR (per 1000 py) = 8.6 (5.1-11.9) versus 7.8 (5.1-11.9); adjusted HR (95% CI) = 0.76 (0.31-1.80), P = 0.52. The rates of adverse GI events in the periods on and off exposure were also similar over a follow-up of 5 years.

Conclusion: Our large, nationwide study shows that the incidence of adverse GI events in patients undergoing dialysis was low and that neither the use of SPS nor CPS was associated with increased GI events risk.

Keywords: adverse gastrointestinal events; calcium polystyrene sulphonate; registry study; sodium polystyrene sulphonate.