- Adjunctive patiromer (Veltassa) allows persistent use of spironolactone (Aldactone) among patients with treatment-resistant hypertension and advanced chronic kidney disease (CKD).
Why this matters
- The potassium binder attenuates hyperkalemia, a cause of spironolactone restriction.
- AMBER phase 2, multinational, double-blind trial of 295 adults with CKD and uncontrolled resistant hypertension, randomly assigned to receive patiromer (8.4 g once daily) or placebo in addition to spironolactone (25 mg once daily).
- Dose titrations were allowed after 1 week (patiromer) and 3 weeks (spironolactone).
- Funding: Relypsa.
- 68.5% of patients were aged ≥65 years; ~50% were female, 49.1% had diabetes, and 44.7% had a history of heart failure.
- Estimated glomerular filtration rate ranged from 25 to ≤45 (mean, ~35.8) mL/minute/1.73 m2.
- At week 12, proportion remaining on spironolactone was significantly greater with patiromer vs placebo (86% vs 66%; Δ=19.5% [95% CI, 10.0%-29.0%]; P<.0001>
- Significantly more patients in the placebo group had serum potassium levels ≥5.5 mmol/L (P<.0001>
- The proportion of patients receiving 50 mg/day spironolactone was higher with patiromer (median dose, 9.8 g) vs placebo (69% vs 51%); mean cumulative dose was 384.7 mg higher (P=.0021).
- Adverse events were generally mild-moderate, and the rate was similar between groups (56% vs 53%).
- Short duration.