TY - JOUR
T1 - Patiromer for the management of hyperkalemia in heart failure with reduced ejection fraction
T2 - the DIAMOND trial
AU - Butler, Javed
AU - Anker, Stefan D.
AU - Lund, Lars H.
AU - Coats, Andrew J.S.
AU - Filippatos, Gerasimos
AU - Siddiqi, Tariq Jamal
AU - Friede, Tim
AU - Fabien, Vincent
AU - Kosiborod, Mikhail
AU - Metra, Marco
AU - Piña, Ileana L.
AU - Pinto, Fausto
AU - Rossignol, Patrick
AU - van der Meer, Peter
AU - Bahit, Cecilia
AU - Belohlavek, Jan
AU - Böhm, Michael
AU - Brugts, Jasper J.
AU - Cleland, John G.F.
AU - Ezekowitz, Justin
AU - Bayes-Genis, Antoni
AU - Gotsman, Israel
AU - Goudev, Assen
AU - Khintibidze, Irakli
AU - Lindenfeld, Joann
AU - Mentz, Robert J.
AU - Merkely, Bela
AU - Montes, Eliodoro Castro
AU - Mullens, Wilfried
AU - Nicolau, Jose C.
AU - Parkhomenko, Aleksandr
AU - Ponikowski, Piotr
AU - Seferovic, Petar M.
AU - Senni, Michele
AU - Shlyakhto, Evgeny
AU - Cohen-Solal, Alain
AU - Szecsödy, Peter
AU - Jensen, Klaus
AU - Dorigotti, Fabio
AU - Weir, Matthew R.
AU - Pitt, Bertram
N1 - Funding Information:
This work was supported by Vifor Pharma. Funding to pay the Open Access publication charge for this article was provided by Vifor Pharma.
Publisher Copyright:
© 2022 The Author(s). Published by Oxford University Press on behalf of European Society of Cardiology.
PY - 2022/11/1
Y1 - 2022/11/1
N2 - 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).
AB - 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).
UR - http://www.scopus.com/inward/record.url?scp=85138342797&partnerID=8YFLogxK
U2 - 10.1093/eurheartj/ehac401
DO - 10.1093/eurheartj/ehac401
M3 - Article
C2 - 35900838
AN - SCOPUS:85138342797
SN - 0195-668X
VL - 43
SP - 4362
EP - 4373
JO - European Heart Journal
JF - European Heart Journal
IS - 41
ER -