Patiromer for the management of hyperkalemia in heart failure with reduced ejection fraction: the DIAMOND trial - Université Sorbonne Paris Nord Accéder directement au contenu
Article Dans Une Revue European Heart Journal Année : 2022

Patiromer for the management of hyperkalemia in heart failure with reduced ejection fraction: the DIAMOND trial

1 The University of Mississippi [Oxford]
2 Baylor Scott and White Research Institute [Dallas, TX, USA]
3 Charité - UniversitätsMedizin = Charité - University Hospital [Berlin]
4 DZHK - German Center for Cardiovascular Research
5 Charité Campus Virchow-Klinikum (CVK)
6 BCRT - Berlin-Brandenburg Center for Regenerative Medicine [Berlin, Germany]
7 Karolinska University Hospital [Stockholm]
8 Karolinska Institutet [Stockholm]
9 University of Warwick [Coventry]
10 NKUA - National and Kapodistrian University of Athens
11 “Attikon” University Hospital
12 UMG - University Medical Center Göttingen
13 Vifor Pharma Ltd [Glattbrugg, Switzerland]
14 Saint Luke's Mid America Heart Institute
15 UMKC - University of Missouri [Kansas City]
16 UniBs - Università degli Studi di Brescia = University of Brescia
17 Azienda Socio Sanitaria Territoriale Spedali Civili di Brescia [Brescia]
18 CMU - Central Michigan University
19 NOVA - Universidade Nova de Lisboa = NOVA University Lisbon
20 Faculdade de Medicina [Lisboa]
21 Hospital de Santa Maria [Lisboa]
22 DCAC - Défaillance Cardiovasculaire Aiguë et Chronique
23 CIC-P - Centre d'investigation clinique plurithématique Pierre Drouin [Nancy]
24 INI-CRCT - Cardiovascular and Renal Clinical Trialists [Vandoeuvre-les-Nancy]
25 Cardiovascular & Renal Clinical Trialists - CRCT - French-Clinical Research Infrastructure Network - F-CRIN [Paris]
26 UMCG - University Medical Center Groningen [Groningen]
27 INECO Neurociencias Oroño, Rosario
28 Medicine Charles University and General Faculty Hospital in Prague
29 Saarland University [Saarbrücken]
30 Erasmus MC - Erasmus University Medical Center [Rotterdam]
31 University of Glasgow
32 University of Alberta
33 GTPUH - Germans Trias i Pujol University Hospital [Badalona, Barcelona, Spain]
34 Hadassah Hebrew University Medical Center [Jerusalem]
35 Medical University of Sofia [Bulgarie]
36 Tbilisi State University
37 Vanderbilt University [Nashville]
38 Duke University [Durham]
39 Semmelweis University of Medicine [Budapest]
40 Heart Institute of Queretaro
41 UHasselt - Hasselt University
42 ZOL - Ziekenhuis Oost-Limburg
43 USP - Universidade de São Paulo = University of São Paulo
44 UWr - University of Wrocław [Poland]
45 SASA - Serbian Academy of Sciences and Arts
46 University of Belgrade [Belgrade]
47 UNIMI - Università degli Studi di Milano = University of Milan
48 Azienda Ospedaliera Ospedale Papa Giovanni XXIII [Bergamo, Italy]
49 Almazov National Medical Research Centre (St. Petersburg)
50 MASCOT (UMR_S_942 / U942) - Marqueurs cardiovasculaires en situation de stress
51 Hôpital Lariboisière-Fernand-Widal [APHP]
52 University of Maryland School of Medicine
53 University of Michigan Medical School [Ann Arbor]
Michael Böhm

Résumé

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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Dates et versions

hal-03792933 , version 1 (30-09-2022)

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Paternité - Pas d'utilisation commerciale

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Citer

Javed Butler, Stefan D Anker, Lars H Lund, Andrew J S Coats, Gerasimos Filippatos, et al.. Patiromer for the management of hyperkalemia in heart failure with reduced ejection fraction: the DIAMOND trial. European Heart Journal, 2022, 43 (41), pp.4362-4373. ⟨10.1093/eurheartj/ehac401⟩. ⟨hal-03792933⟩
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