Patiromer For The Management Of Hyperkalemia In Subjects Receiving RAAS-Inhibitors For Heart Failure With Reduced Ejection Fraction: Results From The DIAMOND Trial

Presented at ESC Heart Failure 2022 by Prof. Stefan Anker, MD, PhD (Berlin, Germany)

Introduction and methods

The DIAMOND trial enrolled HFrEF patients who had hyperkalemia on RAASi therapy or had a history of hyperkalemia due to RAASi therapy that resulted in downregulation of RAASi. First, 1195 patients entered the run-in phase, in which they were optimized on RAASi therapy, defined as requiring ≥50% doses of ACEi/ARB/ARNI and ≥50 mg dose of MRA, with the use of patiromer. 878 Patients that achieved optimized therapy were randomized to continuation of patiromer (n=439) or to withdrawal of patiromer and switched to placebo (n=439) in a double-blinded fashion.

When the trial was designed, the primary endpoint was determined as time to CV death or first CV hospitalization. But because of COVID-related issues, the primary endpoint was changed to the adjusted mean change in serum potassium levels at the end of the study.

End of study was in June 2021, average duration of follow-up was 266.6 days.

Results

• 85% of patients could be optimized to guideline-recommended doses of RAASi during the run-in phase of the study.
• The adjusted mean change in potassium was 0.03 (95%CI: -0.01 to 0.07) in the patiromer group and 0.13 (95%CI: 0.09 to 0.16) in the placebo group; a between group difference of -0.10 (95%CI: -0.13 to -0.07), P<0.001).
• The secondary endpoints time to first event of hyperkalemia, time to lowering of MRA dose below target, total investigator-reported adverse events of hyperkalemia, win-ratio for morbidity and mortality adjusted hyperkalemia-related outcomes, the win ratio of novel RAASi use-score were all significantly changed in favor of patiromer.

Conclusion

Use of patiromer resulted in maintenance of lower levels of potassium in patients with HFrEF who were optimized on RAASi therapy, and reduced the risk of hyperkalemia, and enabled guideline-recommended RAASi therapy.

– Our coverage of ESC Heart Failure 2022 is based on the information provided during the congress –