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Title: | Patiromer for the management of hyperkalemia in heart failure with reduced ejection fraction: the DIAMOND trial | Authors: | Butler, Javed Anker, Stefan D. Lund, Lars H. Coats, Andrew J. S. Filippatos, Gerasimos Siddiqi, Tariq Jamal Friede, Tim Fabien, Vincent Kosiborod, Mikhail Metra, Marco Pina, Ileana L. Pinto, Fausto Rossignol, Patrick van der Meer, Peter Bahit, Cecilia Belohlavek, Jan Boehm, Michael Brugts, Jasper J. Cleland, John G. F. Ezekowitz, Justin Bayes-Genis, Antoni Gotsman, Israel Goudev, Assen Khintibidze, Irakli Lindenfeld, Joann Mentz, Robert J. Merkely, Bela Montes, Eliodoro Castro MULLENS, Wilfried Nicolau, Jose C. Parkhomenko, Aleksandr Ponikowski, Piotr Seferovic, Petar M. Senni, Michele Shlyakhto, Evgeny Cohen-Solal, Alain Szecsoedy, Peter Jensen, Klaus Dorigotti, Fabio Weir, Matthew R. Pitt, Bertram |
Issue Date: | 2022 | Publisher: | OXFORD UNIV PRESS | Source: | European heart journal, | Status: | Early view | Abstract: | 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). | Notes: | Butler, J (corresponding author), Baylor Scott & White Res Inst, Dallas, TX 75204 USA.; Butler, J (corresponding author), Univ Mississippi, Dept Med, Jackson, MS 39216 USA.; Anker, SD (corresponding author), Dept Cardiol CVK, Berlin, Germany.; Anker, SD (corresponding author), Berlin Inst Hlth Ctr Regenerat Therapies BCRT, Berlin, Germany.; Anker, SD (corresponding author), German Ctr Cardiovasc Res DZHK, Partner Site Berlin, Berlin, Germany.; Anker, SD (corresponding author), Charite, Berlin, Germany. jbutler4@umc.edu; s.anker@cachexia.de |
Keywords: | Heart failure with reduced ejection fraction;Renin-angiotensin-aldosterone system inhibitor (RAASi);Hyperkalemia;Patiromer;Potassium-binding polymer | Document URI: | http://hdl.handle.net/1942/38124 | ISSN: | 0195-668X | e-ISSN: | 1522-9645 | DOI: | 10.1093/eurheartj/ehac401 | ISI #: | 000843014600001 | Rights: | © The Author(s) 2022. Published by Oxford University Press on behalf of European Society of Cardiology. This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial License (https://creativecommons.org/licenses/by-nc/4.0/), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is properly cited. For commercial re-use, please contact journals.permissions@oup.com | Category: | A1 | Type: | Journal Contribution | Validations: | ecoom 2023 |
Appears in Collections: | Research publications |
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