Key result
Patiromer reduces serum potassium by ~0.10 mmol/L versus placebo in HFrEF with RAASi-related hyperkalemia.
Why the study?
To investigate the impact of patiromer on serum potassium and its ability to enable specified target doses of RAASi therapy in patients with HFrEF.
Does patiromer reduce serum potassium and enable RAASi use in patients with HFrEF and RAASi-related hyperkalemia?
RCT (n=878)
Double-blind
1:1 ratio, permuted block design
Yes
Does patiromer reduce serum potassium and enable RAASi use in patients with HFrEF and RAASi-related hyperkalemia?
Mean Difference: -0.1 (95% CI -0.13–-0.07)
Absolute Event Rate: 0.03% vs 0.13%
p-value: p=<0.001
In patients with HFrEF and RAASi-related hyperkalemia, patiromer significantly reduced serum potassium levels and the risk of recurrent hyperkalemia compared to placebo, enabling higher utilization of MRAs.
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
“These data suggest that you can simultaneously control potassium and optimize RAASi therapy, and perhaps in the long run, it would improve clinical outcomes, but we did not have enough outcomes to make any definitive conclusion in that respect.”
“Hyperkalemia is one of the most common fears that clinicians articulate with regard to closing gaps in GDMT in HF patients.”
“Good polypharmacy helps us meet goals and initiatives. DIAMOND provides evidence that there are additional tools out there that might help clinicians to better meet therapy optimization goals.”
I need the trial identity and primary endpoint context before drafting the implication.This is DIAMOND. I’ll pull the primary-endpoint framing and whether outcomes were powered.I need the trial’s outcome limitation and conclusion wording so the implication stays accurate.Supports patiromer to sustain target-dose MRA in HFrEF at hyperkalemia risk; confirms binder efficacy and leaves open CV outcome
AIMS: To investigate the impact of patiromer on the serum potassium level and its ability to enable specified target doses of renin-angiotensin-aldosterone system inhibitor (RAASi) use in patients with heart failure and reduced ejection fraction (HFrEF). METHODS AND RESULTS: A total of 1642 patients with HFrEF and current or a history of RAASi-related hyperkalemia were screened and 1195 were enrolled in the run-in phase with patiromer and optimization of the RAASi therapy [≥50% recommended dose of angiotensin-converting enzyme inhibitor/angiotensin receptor blocker/angiotensin receptor-neprilysin inhibitor, and 50 mg of mineralocorticoid receptor antagonist (MRA) spironolactone or eplerenone]. Specified target doses of the RAASi therapy were achieved in 878 (84.6%) patients; 439 were randomized to patiromer and 439 to placebo. All patients, physicians, and outcome assessors were blinded to treatment assignment. The primary endpoint was between-group difference in the adjusted mean change in serum potassium. Five hierarchical secondary endpoints were assessed. At the end of treatment, the median (interquartile range) duration of follow-up was 27 (13-43) weeks, the adjusted mean change in potassium was +0.03 mmol/l in the patiromer group and +0.13 mmol/l in the placebo group [difference in the adjusted mean change between patiromer and placebo: -0.10 mmol/l (95% confidence interval, CI -0.13, 0.07); P < 0.001]. Risk of hyperkalemia >5.5 mmol/l [hazard ratio (HR) 0.63; 95% CI 0.45, 0.87; P = 0.006), reduction of MRA dose (HR 0.62; 95% CI 0.45, 0.87; P = 0.006), and total adjusted hyperkalemia events/100 person-years (77.7 vs. 118.2; HR 0.66; 95% CI 0.53, 0.81; P < 0.001) were lower with patiromer. Hyperkalemia-related morbidity-adjusted events (win ratio 1.53, P < 0.001) and total RAASi use score (win ratio 1.25, P = 0.048) favored the patiromer arm. Adverse events were similar between groups. CONCLUSION: Concurrent use of patiromer and high-dose MRAs reduces the risk of recurrent hyperkalemia (ClinicalTrials.gov: NCT03888066).
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Butler et al. (2022) conducted an RCT in Heart failure with reduced ejection fraction (HFrEF) and RAASi-related hyperkalemia (n=878). Patiromer vs. Placebo was evaluated on Adjusted mean change in serum potassium from baseline (MD -0.10, 95% CI -0.13, -0.07, p=<0.001). Patiromer significantly reduced serum potassium levels by a mean difference of -0.10 mmol/l compared to placebo in patients with heart failure with reduced ejection fraction and RAASi-related hyperkalemia.
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