Spironolactone Does Not Reduce Risk for Cardiovascular Morbidity, Mortality in Patients on Dialysis

THURSDAY, Aug. 28, 2025 (HealthDay News) — Spironolactone does not reduce a composite outcome of cardiovascular mortality and hospitalization due to heart failure among patients receiving maintenance dialysis, according to a study published online Aug. 16 in The Lancet and presented at the 62nd European Renal Association Congress, held from June 4 to 7 in Vienna.

Michael Walsh, M.D., Ph.D., from McMaster University in Hamilton, Ontario, Canada, and colleagues conducted an international randomized controlled trial in 143 dialysis programs in 12 countries involving adult patients who were receiving maintenance dialysis for kidney failure for at least three months. Patients who were able to tolerate and adhere to spironolactone 25 mg daily orally during an open-label run-in were randomly assigned to continue spironolactone or matching placebo in a 1:1 ratio (1,260 and 1,278, respectively).

The external safety and efficacy monitoring committee recommended the trial be stopped early for futility after a planned interim analysis of 75 percent of the expected primary outcome events. Patients were followed for a median of 1.8 years. The researchers found that the composite primary outcome of cardiovascular mortality or hospitalization for heart failure occurred in 258 and 276 participants in the spironolactone and placebo groups, respectively (10.46 and 11.33 events per 100 patient-years; hazard ratio, 0.92; 95 percent confidence interval, 0.78 to 1.09). Death from any cause and hospitalization from any cause were similar between the groups.

“While the results are not what we wanted, they provide much-needed clarity. This study moves us one step closer to finding effective and safe treatments for a group that urgently needs them,” Walsh said in a statement.

Several authors disclosed ties to the biopharmaceutical industry.

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