Table 3:
Summary of reported safety outcomes of MRA as compared to placebo in included studies.
| Study authors, Year | Hyperkalemia * | Worsening renal function (change in eGFR) ** | Dose reduction or drug discontinuation due to adverse effects |
|---|---|---|---|
| HFrEF | |||
| Vardney et al, 2012 | Serum K+ >5.5 mmol/l: OR 3.7, 95% CI 2.5–5.7 | IR 17% vs 7%, p< 0.001 | OR 2.3, 95% CI 1.2–4.7 |
| Eschalier et al, 2013 | Serum K+ >5.5 mmol/l: IR 16.6% vs 9.3%, p=0.002 Serum K+ >6 mmol/l: IR 1.9% vs 3.3%, p=0.29 |
Mean ±SD 2.04 ±17.0 vs 4.15 ±14.9 | IR 16.1% vs 22.3%, p<0.05 |
| Inampudi et al, 2014 | NR | NR | NR |
| HFpEF | |||
| Beldhuis et al, 2019 | NR | eGFR 45–60, HR 3.80 95% CI 2.24–6.45; eGFR 30–45, HR 2.12 95% CI 1.41–3.19, p=0.46 eGFR 45–60: 4-Yr ARD +24%, 95% CI + 14% to +33%; eGFR 30–45: 4-Yr ARD +27%, 95% CI +12% to +42% |
NR |
| Acute HF | |||
| Greene et al, 2019 | 30 day: IR of ≤ 2% for both groups. | NR | NR |
| Oh et al, 2015 | NR | NR | NR |
| Mixed HF | |||
| Stubnova et al, 2017 | Δ potassium: Mean ± SD 0.31 ± 0.55 vs 0.05 ± 0.41 mmol/l, p<0.0001 | Δ eGFR: Mean ± SD −4.12 ± 12.2 vs −0.98 ± 7.88 ml/min/1.73 m2, p= 0.006 | NR |
Footnote: absolute risk difference (ARD), change (Δ), confidence interval (CI), estimated glomerular filtration rate (eGFR), hazards ratio (HR), heart failure (HF), heart failure with preserved ejection fraction (HFpEF), heart failure with reduced ejection fraction (HFrEF), incidence rate (IR), mineralocorticoid receptor antagonist (MRA), not reported (NR), odd ratio (OR), propensity scored (PS), standard deviation (SD), serum potasium (K+), versus (vs).
*
Serum K+ values are reported in mmol/L.
**
eGFR values are reported in mL/min/1.73 m2.