Summary of findings 1. Aldosterone antagonists (spironolactone or eplerenone) versus control (placebo or standard care) for people with chronic kidney disease requiring dialysis.
| Aldosterone antagonists (spironolactone or eplerenone) versus control (placebo or standard care) for people with chronic kidney disease requiring dialysis | |||||
| Patient or population: people with chronic kidney disease requiring dialysis Setting: haemodialysis and peritoneal dialysis Intervention: aldosterone antagonists (spironolactone or eplerenone) Comparison: control (placebo or standard care) | |||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect (95% CI) | No. of participants (RCTs) | Certainty of the evidence (GRADE) | |
| Risk with control (placebo or standard care) | Risk with aldosterone antagonists (spironolactone or eplerenone) | ||||
| Death (any cause) | 131 per 1,000 | 59 per 1,000 (39 to 88) | RR 0.45 (0.30 to 0.67) | 1119 (9) | ⊕⊕⊕⊝ MODERATE 1 |
| Death (cardiovascular) | 101 per 1,000 | 37 per 1,000 (22 to 65) | RR 0.37 (0.22 to 0.64) | 908 (6) | ⊕⊕⊕⊝ MODERATE 1 |
| Cardiovascular and cerebrovascular morbidity | 133 per 1,000 | 51 per 1,000 (24 to 101) | RR 0.38 (0.18 to 0.76) | 328 (3) | ⊕⊕⊕⊝ MODERATE 1 |
| Hyperkalaemia | 91 per 1,000 | 128 per 1,000 (66 to 253) | RR 1.41 (0.72 to 2.78) | 981 (9) | ⊕⊕⊝⊝ LOW 1 2 |
| Gynaecomastia | 5 per 1,000 | 31 per 1,000 (10 to 95) | RR 5.95 (1.93 to 18.28) | 768 (4) | ⊕⊕⊕⊝ MODERATE 1 |
| Left ventricular mass Measured with different units in the different studies. Lower number mean less hypertrophy |
Left ventricular mass in the aldosterone antagonist group was 0.42 standard deviations lower (0.05 to 0.78 lower) compared to placebo or standard care* | ‐‐ | 562 (7) | ⊕⊝⊝⊝ LOW 1 3 | |
| *The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval; RCT: randomised controlled trial; RR: Risk ratio; SMD: standardised mean difference | |||||
| GRADE Working Group grades of evidence High certainty: We are very confident that the true effect lies close to that of the estimate of the effect Moderate certainty: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different Low certainty: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect Very low certainty: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect | |||||
1 The total size of the included in the analysis for this outcome were less than optimal information size.
2 There is inconsistency in the definition of hyperkalaemia between the included studies.
3 There is inconsistency in the measurement and calculation methods of left ventricular mass between the included studies.
* Rule of thumb according to Cohen's interpretation of effect size
- < 0.41 represents a small effect
- 0.40 to 0.70 represents and moderate effect
- > 0.70 represents a large effect