Study Finds Spironolactone Does Not Lower Cardiovascular Risk in Dialysis Patients

A recent clinical trial published in The Lancet has shown that spironolactone, a medication commonly used for heart failure and hypertension, does not significantly reduce the risk of cardiovascular death or hospitalization for heart failure among patients undergoing maintenance dialysis. The study involved 2,538 adults across 12 countries, who were randomly assigned to receive either spironolactone at 25 mg daily or a placebo, after an initial open-label run-in phase.

Patients were followed for a median period of 1.8 years, during which the primary composite outcome—comprising cardiovascular mortality and hospitalization due to heart failure—occurred in approximately 10.5% of the spironolactone group and 11.3% of the placebo group. Statistical analysis revealed a hazard ratio of 0.92, indicating no significant benefit from spironolactone in reducing these cardiovascular events. Additionally, mortality from all causes and hospitalizations for any reason were similar between both groups.

The trial was halted early due to futility after an interim analysis suggested that continuing the study would unlikely demonstrate a benefit. Lead researcher Dr. Michael Walsh from McMaster University emphasized that while the results were disappointingly neutral, they provide critical clarity on the use of spironolactone in this vulnerable patient population. The findings suggest that routine use of spironolactone for cardiovascular risk reduction in dialysis patients may not be justified, highlighting the need to explore other therapeutic strategies.

Several authors involved in the study reported ties to the biopharmaceutical industry. For more detailed information, the full study is available in The Lancet (2025). Source: https://medicalxpress.com/news/2025-08-spironolactone-cardiovascular-morbidity-mortality-patients.html