Spironolactone not useful in dialysis with cardiovascular risk

Spironolactone versus placebo did not provide benefit in terms of cardiovascular mortality or hospitalisation from heart failure, but increased severe hyperkalaemia in patients with cardiovascular risk undergoing dialysis, according to results of the ACHIEVE trial.

Dr Michael Walsh (McMaster University, Canada) presented the phase 3 ACHIEVE trial (NCT03020303), which included eligible patients in an initial run-in period lasting ≥7 weeks, receiving open-label spironolactone 25 mg daily [1]. This was followed by a final eligibility assessment (serum potassium ≤6.0 mmol/L and ≥80% adherence), and 1:1 randomisation to spironolactone 25 mg daily or placebo. Participants were eligible for initial inclusion if they were on maintenance dialysis with cardiovascular death risk (>45 years of age, or >18 years and with diabetes mellitus). The primary endpoint of the trial was the composite of cardiovascular mortality or hospitalisation for heart failure. In total, 3,565 participants were included in the run-in period, and 2,538 were randomised.

The trial was stopped early due to futility and did not meet the primary endpoint, with 11.33 events/100 patient-years reported with placebo and 10.46 events/100 patient-years reported with spironolactone (HR 0.92; 95% CI 0.78–1.09; P=0.35). Further analysis of the primary endpoint did not show a benefit of spironolactone among subgroups defined by previous heart failure, previous coronary artery disease, or dialysis vintage (>1 or ≤1 year), but there did seem to be an effect in men (P=0.02). Finally, total severe hyperkalaemia tended to be more common with spironolactone than placebo (4.97 vs 3.23 events/100 patient-years; HR 1.54; 95% CI 1.07–2.22).

“Spironolactone 25 mg daily did not reduce the composite of cardiovascular death or heart failure hospitalisation in patients receiving maintenance dialysis,” concluded Dr Walsh. “Hyperkalaemia still limits drug use despite run-in, and it is common in our patients, although severe hyperkalaemia was uncommon. Cardiovascular mortality remains very high, and 11% per year in the trial population is still somewhat of an outstanding number.”

1. Walsh M, et al. Spironolactone in patients undergoing maintenance dialysis: the ACHIEVE trial. 62nd ERA Congress, 4–7 June 2025, Vienna, Austria.

Medical writing support was provided by Mihai Surducan, PhD.

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Posted on 10 June 2025