{
  "abstract": "Background and Importance Finerenone, a mineralocorticoid receptor antagonist, is the first in its class to show benefit in heart failure (HF) with preserved ejection fraction. In FINEARTS-HF, 1 it reduced the composite of worsening heart failure and cardiovascular death, mainly through fewer hospitalisations (RR 0.84, 95% CI 0.74–0.95). A decade earlier, spironolactone showed no benefit in TOPCAT2 for its composite of cardiovascular death and HF hospitalisation/events (HR 0.89, 95% CI 0.77–1.04). These discrepancies may reflect trial design and endpoint definitions rather than pharmacological differences.3 Aim and Objectives To compare the efficacy of finerenone and spironolactone through indirect adjusted comparisons (ICs) of the individual components of the primary composites from FINEARTS-HF and TOPCAT.Material and Methods Both trials were reviewed. Two components were analysed: HF hospitalisation/events and cardiovascular death. When both trials reported the same estimator (eg, hazard ratio [HR]), that was used; otherwise, a rate ratio (RR) was calculated from trial data using the comparator trial’s analytic approach. ICs used the Bucher method, with finerenone as reference. A delta margin (Δ) = 0.80 (inverse 1.25) defined clinical irrelevance, based on values used in both trials for sample size calculations (19–20%). Clinical equivalence required a 95% CI entirely within 0.80–1.25.Results For cardiovascular death, both trials reported HRs and were non-significant: HR 0.90 (0.73–1.12) in TOPCAT and 0.93 (0.78–1.11) in FINEARTS-HF. The indirect HR was 0.97 (0.73–1.28), outside the 0.80–1.25 equivalence bounds on both sides.For HF hospitalisation/events, FINEARTS-HF reported RR 0.82 (0.71–0.94) and TOPCAT HR 0.83 (0.69–0.99). To enable a like-for-like comparison, a TOPCAT RR was calculated from total HF hospitalisations and person-time (RR 0.82, 95% CI 0.71–0.94). The indirect RR was 1.00 (0.82–1.21), within equivalence.Conclusion and Relevance ICs of individual components showed no statistically significant differences. Both drugs were clinically equivalent for HF hospitalisation/events, the main driver of outcomes. Both were neutral for cardiovascular death, with both equivalence margins exceeded, indicating no benefit in favour of either drug. This supports the view that discrepancies in the composite endpoint are due to trial design (higher power, larger sample, and fewer patients with LVEF ≥60% in FINEARTS-HF). Limitations include discordant primary outcomes, population differences, and geographic and temporal variability.References and/or Acknowledgements 1. https://pubmed.ncbi.nlm.nih.gov/39225278/2. https://pubmed.ncbi.nlm.nih.gov/24716680/3. https://pubmed.ncbi.nlm.nih.gov/39813655/Conflict of Interest No conflict of interest",
  "authors": [
    {
      "affiliations": [
        "Hospital Universitario De Móstoles, Hospital Pharmacy, Móstoles, Spain"
      ],
      "name": "AB Pousada Fonseca"
    },
    {
      "affiliations": [
        "Hospital Universitario De Fuenlabrada, Hospital Pharmacy, Fuenlabrada, Spain"
      ],
      "name": "J Pedreira Bouzas"
    },
    {
      "affiliations": [
        "Hospital Universitario De Móstoles, Hospital Pharmacy, Móstoles, Spain"
      ],
      "name": "D García Martínez"
    }
  ],
  "title": "6ER-015 Pieces of the whole: an indirect comparison of finerenone and spironolactone",
  "uid": "023ee306-7482-57eb-8cb5-1493a7271a93"
}