Table 5.
Recent major clinical trials of MRA in cardiorenal syndrome and their relationship with adiposity
| Trial | n (follow-up) | BMI > 30 % | eGFR % < 60 mL/min | CVD(%) vs HF(%) | DM2 | CV and RO (HR, significant) |
| EMPHASIS-HF[159] (eplerenone vs PBO) | 2737 (21 mo) | 27% | 33% | 70% (IHD) | 31% | CVO1,2,3,4,5 |
| HFrEF (NYHAII) | RO: NS | |||||
| High WC: Greater benefit of eplerenone[163] | ||||||
| TOPCAT[96] (spironolactone vs PBO) | 3445 (3.3 yr) | 50% | 39% | 59%(IHD) | 32% | CVO4 |
| HFpEF (NYHAII-IV) | ||||||
| TOPCAT post hoc[193] (BMI&NP categories) | 997 (3.3 yr) | NR | NR | NR | NR | High BMI/high NP1,4,5 |
| High NP5 | ||||||
| TOPCAT post hoc[166] (eGFR categories) | 1767 (3.3 yr) | 70% | 53.4% | MI (20.3%) | 44.5% | AE increased with declining eGFR eGFR ≥ 60 vs eGFR ≤ 451,2,4,5 |
| FIDELIO-DKD[170] (finerenone vs PBO) | 5734 (< 48 mo) | 58% | 87% | 45.9% & 7.5 (HFpEF) | 100% | Outcomes expected in 2020 (composite RO and secondary endpoints CV ) |
| FIGARO-DKD[171] (finerenone vs PBO) | 7437 (< 53 mo) | 60% | 38% | 44.3% & 7.6% (HFpEF) | 100% | Outcomes expected in 2021 (composite RO and secondary endpoints CV ) |
| AMBER[167] (patiromer vs PBO) | 295 (3 mo) | NR | 100% | 19.3% (MI) & 45% (HF) | 49.1% | Les hyperkaliemia |
| Less Spironolactone withdrawal |
CVD: Coronary artery disease, peripheral arterial, myocardial infarction, ischemic stroke, endarterectomy carotid; BMI: Body mass index; HF: Heart failure; PBO: Placebo; CVO: Cardiovascular outcomes; eGFR: Estimated glomerular filtration rate; IHD: Ischemic heart disease; MI: Myocardial infarction; NP: Natriuretic peptide; RO: Renal outcomes; WC: Waist circumference; O: Outcomes; DM2: Diabetes mellitus type 2; NR: Not reported.
1
Primary outcome (composite1,2,3).
2
Mortality CV.
3
Aborted cardiac arrest.
4
Hospitalization for heart failure.
5
Death from any cause.