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

被引：144

作者：

Butler, Javed ^{[1
,2
]}

Anker, Stefan D. ^{[3
,4
,5
,6
]}

Lund, Lars H. ^{[7
,8
]}

Coats, Andrew J. S. ^{[9
]}

Filippatos, Gerasimos ^{[10
,11
]}

Siddiqi, Tariq Jamal ^{[1
,2
]}

Friede, Tim ^{[12
,13
,14
]}

Fabien, Vincent ^{[15
]}

Kosiborod, Mikhail ^{[16
,17
]}

Metra, Marco ^{[18
]}

Pina, Ileana L. ^{[19
]}

Pinto, Fausto ^{[20
]}

Rossignol, Patrick ^{[21
,22
]}

van der Meer, Peter ^{[23
]}

Bahit, Cecilia ^{[24
]}

Belohlavek, Jan ^{[25
]}

Boehm, Michael ^{[26
]}

Brugts, Jasper J. ^{[27
]}

Cleland, John G. F. ^{[28
]}

Ezekowitz, Justin ^{[29
]}

Bayes-Genis, Antoni ^{[30
]}

Gotsman, Israel ^{[31
]}

Goudev, Assen ^{[32
]}

Khintibidze, Irakli ^{[33
]}

Lindenfeld, Joann ^{[34
]}

Mentz, Robert J. ^{[35
]}

Merkely, Bela ^{[36
]}

Montes, Eliodoro Castro ^{[37
]}

Mullens, Wilfried ^{[38
,39
]}

Nicolau, Jose C. ^{[40
,41
]}

Parkhomenko, Aleksandr ^{[42
]}

Ponikowski, Piotr ^{[43
]}

Seferovic, Petar M. ^{[44
,45
]}

Senni, Michele ^{[46
]}

Shlyakhto, Evgeny ^{[47
]}

Cohen-Solal, Alain ^{[48
]}

Szecsody, Peter ^{[15
]}

Jensen, Klaus ^{[15
]}

Dorigotti, Fabio ^{[15
]}

Weir, Matthew R. ^{[49
]}

Pitt, Bertram ^{[50
]}

机构：

[1] Baylor Scott & White Res Inst, Dallas, TX 75204 USA

[2] Univ Mississippi, Dept Med, Jackson, MS 39216 USA

[3] Dept Cardiol CVK, Berlin, Germany

[4] Berlin Inst Hlth Ctr Regenerat Therapies BCRT, Berlin, Germany

[5] German Ctr Cardiovasc Res DZHK, Partner Site Berlin, Berlin, Germany

[6] Charite, Berlin, Germany

[7] Karolinska Inst, Dept Med, Unit Cardiol, Stockholm, Sweden

[8] Karolinska Univ Hosp, Dept Cardiol, Stockholm, Sweden

[9] Univ Warwick, Warwick, England

[10] Natl & Kapodistrian Univ Athens, Athens Univ, Sch Med, Athens, Greece

[11] Hosp Attikon, Athens, Greece

[12] Dept Internal Med, Gottingen, Germany

[13] Univ Med Ctr Gottingen, Gottingen, Germany

[14] DZHK German Ctr Cardiovasc Res, Gottingen Partner Site, Gottingen, Germany

[15] Vifor Pharma, Glattbrugg, Switzerland

[16] St Lukes Mid Amer Heart Inst, Dept Cardiovasc Dis, Kansas City, MO USA

[17] Univ Missouri, Kansas City, MO 64110 USA

[18] ASST Spedali Civili & Univ, Cardiol, Brescia, Italy

[19] Cent Michigan Univ, Coll Med, Mt Pleasant, MI 48859 USA

[20] Univ Lisbon, Santa Maria Univ Hosp, CCUL, CAML,Fac Med, Lisbon, Portugal

[21] X Univ Lorraine, INSERM, Ctr Invest Clin Plurithemat 1433, INSERM Unit 1116,Ctr Hosp Reg Univ,CHRU, Nancy, France

[22] F CRIN INI CRCT, Nancy, France

[23] Univ Med Ctr Groningen, Dept Cardiol, Groningen, Netherlands

[24] INECO Neurociencias Orono, Santa Fe, NM USA

[25] Gen Univ Hosp Prague, Clin Cardiol & Angiol, Prague, Czech Republic

[26] Saarland Univ, Klin Innere Med 3, Homburg, Germany

[27] Erasmus MC Univ Med Ctr, Rotterdam, Netherlands

[28] Univ Glasgow, Inst Hlth & Wellbeing, Glasgow, Lanark, Scotland

[29] Univ Alberta, Fac Med & Dent, Edmonton, AB, Canada

[30] Hosp Badalona Germans Trias & Pujol, Cardiol Dept, CIBERCV, Barcelona, Spain

[31] Hadassah Med Ctr, Jerusalem, Israel

[32] Med Univ Sofia, Dept Emergency Med, Sofia, Bulgaria

[33] Tbilisi State Med Univ, Alexandre Aladashvili Clin, Tbilisi, Georgia

[34] Vanderbilt Univ Sch Med, Dept Med, Nashville, TN USA

[35] Duke Univ, Sch Med, Dept Med, Durham, NC 27706 USA

[36] Semmelweis Univ, Heart & Vasc Ctr, Budapest, Hungary

[37] Heart Inst Queretaro, Mexico City, DF, Mexico

[38] Ziekenhuis Oost Limburg Genk, Genk, Belgium

[39] Univ Hasselt, Hasselt, Belgium

[40] Hosp Clin HCFMUSP, Fac Med, Inst Coracao InCor, Sao Paulo, Brazil

[41] Univ Sao Paulo, Sao Paulo, SP, Brazil

[42] Hosp Oost Limburg, Genk, Belgium

[43] Wroclaw Med Univ, Inst Heart Dis, Wroclaw, Poland

[44] Fac Med Belgrade, Belgrade, Serbia

[45] Serbian Acad Arts & Sci, Belgrade, Serbia

[46] Univ Milano Bicocca, Papa Giovanni Hosp 23, Cardiovasc Dept, Bergamo, Italy

[47] Almazov Fed Heart Blood & Endocrinol Ctr, St Petersburg, Russia

[48] Univ Paris, Hosp Lariboisiere, AP HP, INSERM U942, Paris, France

[49] Univ Maryland, Sch Med, Dept Med, Div Nephrol, Baltimore, MD 21201 USA

[50] Univ Michigan, Div Cardiol, Ann Arbor, MI 48109 USA

来源：

EUROPEAN HEART JOURNAL | 2022年 / 43卷 / 41期

关键词：

Heart failure with reduced ejection fraction; Renin-angiotensin-aldosterone system inhibitor (RAASi); Hyperkalemia; Patiromer; Potassium-binding polymer; RANDOMIZED ALDACTONE EVALUATION; KIDNEY-DISEASE; SPIRONOLACTONE; INHIBITORS; THERAPY;

D O I：

10.1093/eurheartj/ehac401

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

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).

引用

页码：4362 / 4373

页数：12

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