Table 6.
Randomized controlled trials evaluating the efficacy and safety of newer potassium-binding resins in hyperkalemic patients already treated with RAAS-blockers
| Patient characteristics | n | Year | Design | Intervention | Follow-up | Effect on SK | Major adverse events | Ref |
|---|---|---|---|---|---|---|---|---|
| Studies with Patiromer | ||||||||
|
| ||||||||
| Outpatients with HF and a history of hyperkalemia or CKD receiving standard therapy and add-on spironolactone | 105 | 2011 | Double-blind RCT | Patiromer (30g/day) vs placebo | 4 wks | ↓ | GI disorders (flatulence, diarrhea, constipation and vomiting) were morefrequent in the patiromer than in the placebo group (21% vs 6%, respectively) | 46 |
| Hyperkalemic outpatients with CKD already treated with RAAS-blockers | 107 | 2014 | Randomized, placebo-controlled withdrawal | Patiromer (4.2gr or 8.4gr twice a day) vs placebo | 8 wks | ↓ | Constipation was the most frequently reported adverse event (incidence rate: 11%) | 47 |
| Hyperkalemic outpatients with CKD already treated with RAAS-blockers | 306 | 2015 | Open-Label, dose-ranging RCT | Patiromer (mild hyperkalemia stratum: 4.2, 8.4 or 12.6 gr twice daily; moderate hyperkalemia stratum: 8.4 or 12.6 gr twice daily) versus placebo | 52 wks | ↓ | Hypomagnesemia, constipation and diarrhea had an overall incidence of 8.6%, 6.3% and 5.6%, respectively | 48 |
|
| ||||||||
| Studies with ZS-9 | ||||||||
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| ||||||||
| Hyperkalemic outpatients with HF, CKD or diabetes | 237 | 2014 | Double-blind RCT | ZS-9 (5, 10 or 15 gr daily) vs placebo | 4 wks | ↓ | Dose-dependent increase in the incidence of edema | 49 |
| Hyperkalemic outpatients with HF, CKD or diabetes | 753 | 2015 | Double-blind RCT | ZS-9 (1.25, 2.5, 5, or 10 gr daily) vs placebo | 2 wks | ↓ | GI disorders, mainly diarrhea, were the most commonly reported drug-related complications | 50 |
Abbreviations: CKD= chronic kidney disease; GI= gastro-intestinal; HF= heart failure; RAAS= renin-angiotensin-aldosterone-system; RCT= randomized controlled trial; SK= serum potassium; ZS-9= sodium zirconium cyclosilicate;