TY - JOUR
T1 - Incidence, determinants, and prognostic significance of hyperkalemia and worsening renal function in patients with heart failure receiving the mineralocorticoid receptor antagonist eplerenone or placebo in addition to optimal medical therapy: results
AU - Rossignol, Patrick
AU - Dobre, Daniela
AU - McMurray, John J V
AU - Swedberg, Karl
AU - Krum, Henry
AU - van Veldhuisen, Dirk Jan
AU - Shi, Harry
AU - Messig, Michael
AU - Vincent, John
AU - Girerd, Nicolas
AU - Bakris, George L
AU - Pitt, Bertram
AU - Zannad, Faiez
PY - 2014
Y1 - 2014
N2 - Mineralocorticoid receptor antagonists improve outcomes in patients with systolic heart failure but may induce worsening of renal function (WRF) and hyperkalemia (HK). We assessed the risk factors for mineralocorticoid receptor antagonist?related WRF and for HK, as well as the association between HK and WRF with clinical outcomes in the Eplerenone in Mild Patients Hospitalization and Survival Study in Heart Failure (EMPHASIS-HF).
Methods and Results?Serial changes in estimated glomerular filtration rate and in serum potassium were available in 2737 patients during a median 21-month follow-up. HK variably defined as serum K >4.5, 5, or 5.5 mmol/L occurred in 74.7 , 32.5 , and 8.9 patients enrolled in EMPHASIS-HF, respectively. WRF defined as a decrease in estimated glomerular filtration rate >20 or >30 from baseline occurred in 27 and 14 of patients, respectively. Patients assigned eplerenone displayed modest and early but significant and persistent (1) rise in serum potassium and (2) reduction in estimated glomerular filtration rate when compared with those assigned placebo. In multivariate analyses, eplerenone was associated with a higher incidence of WRF and HK, which were interrelated and also associated with baseline patient characteristics (eg, age =75 years, hypertension, diabetes mellitus, nonwhite race, ejection fraction 5.5 mmol/L only and WRF and worse outcomes.
Conclusions?In patients with heart failure receiving optimal therapy, WRF and HK were more frequent when eplerenone was added, but their occurrence did not eliminate the survival benefit of eplerenone.
AB - Mineralocorticoid receptor antagonists improve outcomes in patients with systolic heart failure but may induce worsening of renal function (WRF) and hyperkalemia (HK). We assessed the risk factors for mineralocorticoid receptor antagonist?related WRF and for HK, as well as the association between HK and WRF with clinical outcomes in the Eplerenone in Mild Patients Hospitalization and Survival Study in Heart Failure (EMPHASIS-HF).
Methods and Results?Serial changes in estimated glomerular filtration rate and in serum potassium were available in 2737 patients during a median 21-month follow-up. HK variably defined as serum K >4.5, 5, or 5.5 mmol/L occurred in 74.7 , 32.5 , and 8.9 patients enrolled in EMPHASIS-HF, respectively. WRF defined as a decrease in estimated glomerular filtration rate >20 or >30 from baseline occurred in 27 and 14 of patients, respectively. Patients assigned eplerenone displayed modest and early but significant and persistent (1) rise in serum potassium and (2) reduction in estimated glomerular filtration rate when compared with those assigned placebo. In multivariate analyses, eplerenone was associated with a higher incidence of WRF and HK, which were interrelated and also associated with baseline patient characteristics (eg, age =75 years, hypertension, diabetes mellitus, nonwhite race, ejection fraction 5.5 mmol/L only and WRF and worse outcomes.
Conclusions?In patients with heart failure receiving optimal therapy, WRF and HK were more frequent when eplerenone was added, but their occurrence did not eliminate the survival benefit of eplerenone.
UR - http://circheartfailure.ahajournals.org/content/7/1/51.full.pdf
U2 - 10.1161/CIRCHEARTFAILURE.113.000792
DO - 10.1161/CIRCHEARTFAILURE.113.000792
M3 - Article
VL - 7
SP - 51
EP - 58
JO - Circulation: Heart Failure
JF - Circulation: Heart Failure
SN - 1941-3289
IS - 1
ER -