Table 4. Summary of 3 clinical trials examining patiromer safety and efficacy.
Study | Patients | Drug | Outcome | Adverse effect |
---|---|---|---|---|
PEARL-HF [106] | 105 pts with CHF+CKD or prior discontinuation of RAAS blocker or beta blocker due to hyperkalemia | Spironolactome + patiromer or placebo, 4 weeks | Placebo: 25% K > 5.5 mEq/L Patiromer: 7% K > 5.5 mEq/L |
24% of patiromer patients Mg < 1.8 mg/dL |
OPAL-HK [107] | 237 pts with CKD stages 3/4 on RAAS blockade | Patiromer, 8 weeks Dose adjustments required in 60% of patients, mostly on days 3 and 7 |
After drug withdrawal: Hyperkalemia in 90% in placebo group vs. 43% in patiromer group Able to continue RAAS blocker: 44% in placebo group vs. 94% in patiromer group |
9 patients in patiromer group required Mg replacement |
AMETHYST-DN [108] | 306 pts with diabetic nephropathy on ACE-I/ARB + spironolactone | Patiromer, 1 year | Significant decrease in serum K+ throughout the study period | Hypomagnesemia; constipation; 30% of patients discontinued treatment |
CHF, congestive heart failure. CKD, chronic kidney disease. RAAS blocker, renin-angiotensin-aldosterone system blocker. ACE-I, angiotensin converting enzyme inhibitor. ARB, angiotensin receptor blocker.