April 03, 2022
3 minute read
Butler J, et al. Joint American College of Cardiology/New England Journal of Medicine Last minute tests. Presented at the American College of Cardiology Scientific Session; April 2-4, 2022; Washington, DC (hybrid meeting).
Disclosures: The study was funded by Vifor Pharma. Butler reports financial ties to Abbott, Adrenomed, American Regent, Amgen, Applied Therapeutics, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Corvia, CVRx, Eli Lilly, FIRE1, G3 Pharmaceutical, Impulse Dynamics, Janssen, LivaNova, Medtronic , Merck, Novartis, Novo Nordisk, Occlutech, Pfizer, Roche and Vifor Pharma.
WASHINGTON – Patiromer, a new potassium binder, has been associated with reduced hyperkalemia in HF patients with reduced ejection fraction, leading to increased adherence to optimal medical therapy, the researchers reported.
“One of the reasons why it is difficult to obtain medical treatment according to guidelines for inhibitors of the renin-angiotensin-aldosterone system, all of which are treatments associated with improved mortality and morbidity in patients with HFrEF, is the risk of hyperkalemia, which tends to be higher in older patients or those with comorbidities such as diabetes and chronic kidney disease,” cardiology today Member of the editorial board Javed Butler, MD, MPH, MBA, FACC, FAHA, FESC, president of the Baylor Scott and White Research Institute, senior vice president of Baylor Scott and White Health and distinguished professor of medicine at the University of Mississippi, said during a press conference at the American College of Cardiology Scientific Session. “The issue is that we have these new potassium binders that are well tolerated, so we can donate them to optimize medical therapies for our patients with HFrEF.”
Patiromer (Vifor Pharma) has been shown to help prevent hyperkalemia and maintain normokalaemia, but its experience in patients with HFrEF is limited. The DIAMOND trial was designed to determine if the drug could control potassium levels and enable optimal RAAS inhibitor therapy, Butler said.
The trial included 878 patients (mean age, 67 years; 27% female) with HF and NYHA Class II-IV EF 5 mEq/L). If a patient had past hyperkalemia, that led to the discontinuation or dose reduction of at least one RAAS inhibitor, Butler said.
The original primary endpoint was time to CV death or first CV hospitalization, but this was changed during the COVID-19 pandemic due to concerns about listing, drug supply and others. factors, Butler said during a presentation. The revised primary endpoint was the adjusted mean change in serum potassium through the end of the study on June 24, 2021.
Of the cohort, 360 patients in the patiromer group and 367 patients in the placebo group completed the blinded study treatment, Butler said.
The change in serum potassium levels from baseline to endpoint was lower in the patiromer group than in the placebo group (patiromer, 0.03 mEq/L; 95% CI, -0.01 to 0 .07; placebo, 0.13 mEq/L; 95% CI, 0.09-0.16; difference, -0.1; 95% CI, -0.13 to -0.07; P
The rate of hyperkalemia > 5.5 mEq/L was lower in the patiromer group than in the placebo group (patiromer, 13.9%; placebo, 19.4%; HR = 0.63; 95% CI, 0 .45-0.87; P = .006), according to the researchers.
The endpoint of mineralocorticoid receptor antagonist dose reduction below target also occurred less often in the patiromer group than in the placebo group (patiromer, 13.9%; placebo, 18 .9%, HR=0.62, 95% CI, 0.45-0.87; P = 0.006), Butler said.
The total number of investigator-reported hyperkalemia events was 225 (77.7 per 100 person-years) in the patiromer group and 316 (118.2 per 100 person-years) in the placebo group (HR = 0.66, 95% CI, 0.53-0.81; P
The researchers also calculated the gain ratios for hyperkalemia-related outcomes and the RAAS inhibitor use score, and both favored patiromer (gain ratio for hyperkalemia = 1.53; CI to 95%, 1.23-1.91; P P = 0.048).
Results for the primary endpoint were consistent across the predefined subgroups except for region, Butler said. Compared to patients from the rest of the world, patients from Eastern Europe had less difference between the patiromer and placebo groups on the primary endpoint (P for interaction = 0.022), but the difference between patiromer and placebo remained significant in Eastern Europe, he said.
Serious adverse events occurred in 12.3% of the patiromer group and 13.2% in the placebo group, while 2.7% of the patiromer group and 2.5% of the placebo group had adverse events leading to withdrawal, Butler said.
“We did not have enough clinical events as the trial was stopped early to comment conclusively on clinical outcomes, but it stands to reason that optimizing RAAS inhibitor therapy without the concomitant risk of hyperkalemia may in the long term lead to better outcomes for these patients,” Butler said at the press conference.