Lancet
Spironolactone fails to cut heart risk in hemodialysis patients
Spironolactone doesn't reduce major CV events or mortality in chronic hemodialysis patients at high CV risk. The evidence doesn't support off-label use of mineralocorticoid receptor antagonists for CV protection in this setting.
Study details: The ALCHEMIST trial (NCT01848639) enrolled 644 adults with kidney failure on chronic hemodialysis and at least one CV comorbidity or risk factor across 64 centers in France, Belgium, and Monaco. After a 4-week open-label run-in with spironolactone 25 mg every other day, participants were randomized (1:1) to spironolactone titrated to 25 mg daily or placebo. Primary endpoint was time to first major adverse cardiovascular event (MACE), analyzed by intention-to-treat. The trial was stopped early due to funding limitations; median follow-up was 32.6 months.
Results: MACE occurred in 24% of both spironolactone and placebo groups (hazard ratio [HR], 1.00; 95% confidence interval [CI], 0.73–1.36; p = 0.98). Hyperkalemia (>6 mmol/L) was reported in 42% (spironolactone) vs. 41% (placebo; HR, 1.12; 95% CI, 0.88–1.43). The updated meta-analysis found no reduction in all-cause or CV mortality, nor in non-fatal CV events, and no increased odds of hyperkalemia.
Source:
Rossignol P; ALCHEMIST study group, et al. (2025, August 16). Lancet. Spironolactone in patients on chronic haemodialysis at high risk of adverse cardiovascular outcomes (ALCHEMIST): a multicentre, double-blind, randomised, placebo-controlled trial and updated meta-analysis. https://pubmed.ncbi.nlm.nih.gov/40818851/