Effect of the mineralocorticoid receptor antagonist eplerenone on liver fat and metabolism in patients with type 2 diabetes: A randomized, double-blind, placebo-controlled trial (MIRAD trial)
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Effect of the mineralocorticoid receptor antagonist eplerenone on liver fat and metabolism in patients with type 2 diabetes : A randomized, double-blind, placebo-controlled trial (MIRAD trial). / Johansen, Marie L.; Schou, Morten; Rossignol, Patrick; Holm, Maria R.; Rasmussen, Jon; Brandt, Niels; Frandsen, Mikkel; Chabanova, Elizaveta; Dela, Flemming; Faber, Jens; Kistorp, Caroline.
In: Diabetes, Obesity and Metabolism, Vol. 21, No. 10, 2019, p. 2305-2314.Research output: Contribution to journal › Journal article › Research › peer-review
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TY - JOUR
T1 - Effect of the mineralocorticoid receptor antagonist eplerenone on liver fat and metabolism in patients with type 2 diabetes
T2 - A randomized, double-blind, placebo-controlled trial (MIRAD trial)
AU - Johansen, Marie L.
AU - Schou, Morten
AU - Rossignol, Patrick
AU - Holm, Maria R.
AU - Rasmussen, Jon
AU - Brandt, Niels
AU - Frandsen, Mikkel
AU - Chabanova, Elizaveta
AU - Dela, Flemming
AU - Faber, Jens
AU - Kistorp, Caroline
PY - 2019
Y1 - 2019
N2 - Aim To investigate whether the mineralocorticoid receptor antagonist eplerenone has beneficial effects on liver fat and metabolism in patients with type 2 diabetes (T2D), the mineralocorticoid receptor antagonist in type 2 diabetes (MIRAD) trial. Material and methods In this 26-week, double-blind, randomized, placebo-controlled trial, we enrolled 140 patients with T2D and high risk of cardiovascular disease. Patients were randomized 1:1 to either eplerenone with a target dose of 200 mg/day for patients with estimated glomerular filtration rate (eGFR) of 60 mL/min per 1.73 m(2) or more and 100 mg/day for patients with eGFR between 41 and 59 mL/min per 1.73 m(2) or placebo. The primary outcome measure was change in liver fat by proton magnetic resonance spectroscopy at week 26 from baseline; secondary outcomes were changes in metabolism, and safety by incident hyperkalaemia. Results No changes in liver fat in the eplerenone group 0.91% (95% CI -0.57 to 2.39) or the placebo group -1.01% (-2.23 to 0.21) were found. The estimated absolute treatment difference was 1.92% (-3.81 to 0.01; P = 0.049). There was no beneficial impact on supporting secondary outcome variables of metabolism as fat mass distribution, lipid metabolism or insulin resistance. Despite a high dosage of eplerenone 164 versus 175 mg in patients treated with placebo (P = 0.228), the number of patients with incident hyperkalaemia (>= 5.5 mmol/L) was low, with six in the eplerenone versus two in the placebo group (P = 0.276). Conclusion The addition of high doses of eplerenone to background antidiabetic and antihypertensive therapy does not show beneficial effects on liver fat and metabolism in patients with T2D.
AB - Aim To investigate whether the mineralocorticoid receptor antagonist eplerenone has beneficial effects on liver fat and metabolism in patients with type 2 diabetes (T2D), the mineralocorticoid receptor antagonist in type 2 diabetes (MIRAD) trial. Material and methods In this 26-week, double-blind, randomized, placebo-controlled trial, we enrolled 140 patients with T2D and high risk of cardiovascular disease. Patients were randomized 1:1 to either eplerenone with a target dose of 200 mg/day for patients with estimated glomerular filtration rate (eGFR) of 60 mL/min per 1.73 m(2) or more and 100 mg/day for patients with eGFR between 41 and 59 mL/min per 1.73 m(2) or placebo. The primary outcome measure was change in liver fat by proton magnetic resonance spectroscopy at week 26 from baseline; secondary outcomes were changes in metabolism, and safety by incident hyperkalaemia. Results No changes in liver fat in the eplerenone group 0.91% (95% CI -0.57 to 2.39) or the placebo group -1.01% (-2.23 to 0.21) were found. The estimated absolute treatment difference was 1.92% (-3.81 to 0.01; P = 0.049). There was no beneficial impact on supporting secondary outcome variables of metabolism as fat mass distribution, lipid metabolism or insulin resistance. Despite a high dosage of eplerenone 164 versus 175 mg in patients treated with placebo (P = 0.228), the number of patients with incident hyperkalaemia (>= 5.5 mmol/L) was low, with six in the eplerenone versus two in the placebo group (P = 0.276). Conclusion The addition of high doses of eplerenone to background antidiabetic and antihypertensive therapy does not show beneficial effects on liver fat and metabolism in patients with T2D.
KW - eplerenone
KW - hyperkalaemia
KW - liver fat
KW - mineralocorticoid receptor antagonist
U2 - 10.1111/dom.13809
DO - 10.1111/dom.13809
M3 - Journal article
C2 - 31183945
VL - 21
SP - 2305
EP - 2314
JO - Diabetes, Obesity and Metabolism
JF - Diabetes, Obesity and Metabolism
SN - 1462-8902
IS - 10
ER -
ID: 224021515