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Efficacy and safety of finerenone in patients with chronic kidney disease: an individual participant data pooled analysis (INFINITY).
This pooled analysis combined patient-level data from three randomized, placebo-controlled trials of finerenone in people with chronic kidney disease (INF…
Signal score64Research triage score
CertaintyModerateVerify in full text
PMID42248158Source identifier
Research triage, not medical advice
Do not use this summary, score, or benefit-cost estimate to diagnose, treat, prescribe, or change care without reviewing the full study and consulting qualified professionals.
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Check full-text methods, eligibility, outcomes, risk of bias, harms, conflicts, funding, replication, and applicability.
Plain-English signal
This pooled analysis combined patient-level data from three randomized, placebo-controlled trials of finerenone in people with chronic kidney disease (INFINITY). Among 14,574 participants, finerenone lowered the risk of a composite kidney outcome (kidney failure or a sustained large drop in kidney function) and reduced the chance of heart-failure hospitalisation, cardiovascular death, and death from any cause compared with placebo. Hyperkalaemia was more common with finerenone, but hospitalisations for hyperkalaemia were reported to be uncommon. The authors conclude finerenone may be useful across many causes of CKD and levels of blood sugar, kidney function, and proteinuria. Full-text review is needed to see absolute benefits and details on harms and monitoring.
Why it matters
- Addresses whether finerenone, a non-steroidal mineralocorticoid receptor antagonist, reduces CKD progression and cardiovascular outcomes across a broad range of CKD aetiologies (not limited to type 2 diabetes).
- Provides pooled, patient-level evidence on kidney failure, sustained large eGFR decline, heart failure hospitalisation, cardiovascular death, and all-cause death-outcomes that directly affect clinical and health system decision-making for CKD management.
- Reports consistency of treatment effects across subgroups defined by glycaemic status, baseline eGFR, albuminuria, CKD aetiology, and concomitant SGLT2 inhibitor use, informing applicability to diverse patient populations.
Primary outcomes
- Composite kidney outcome: kidney failure or sustained >=57% decline in eGFR
- Composite cardiovascular outcome: hospitalisation for heart failure or cardiovascular death
Effect summary
Abstract-reported effects: finerenone reduced the composite kidney outcome versus placebo (hazard ratio 0.76, 95% CI 0.68-0.86; reported event rates 22.3 vs 28.8 per 1000 patient-years) and kidney failure alone (HR 0.85, 95% CI 0.74-0.99). For cardiovascular outcomes, finerenone reduced the composite cardiovascular outcome (HR 0.80, 95% CI 0.70-0.91; 19.1 vs 23.9 events per 1000 patient-years), heart-failure hospitalisation (HR 0.78, 95% CI 0.66-0.92), cardiovascular death (HR 0.82, 95% CI 0.67-0.99), and all-cause death (HR 0.88, 95% CI 0.79-0.99). Hyperkalaemia occurred more frequently with finerenone than placebo, with low absolute incidence of hyperkalaemia leading to hospitalisation reported in the abstract.
Benefit-cost lens
| Quick take | The pooled IPD meta-analysis reports relative risk reductions for kidney and cardiovascular outcomes with finerenone. To convert this into a benefit-cost judgment, absolute baseline risk, absolute event reductions, drug and monitoring costs, eligible population size, and implementation logistics are required. |
|---|---|
| BCR anchor | 2 |
| Time horizon | 3 |
| Discount rate | 0.03 |
| Assumptions | Assessment based solely on PubMed metadata and abstract. Full-text verification of methods, subgroup definitions, absolute risks, and adverse event counts is required before policy or clinical implementation. |
Benefit-cost fields are assumptions-based unless explicitly source-derived. Treat them as prompts for deeper economic review.
Risk of bias
| Tool | rapid-abstract-screen |
|---|---|
| Verdict | Some concerns |
| Notes | Individual participant data meta-analysis of three randomized, double-blind, placebo-controlled trials is a high-quality design; however this assessment is based only on abstract-level information. Key items needing verification: trial inclusion/exclusion criteria, consistency of outcome definitions across trials, handling of missing data, adjudication of outcomes, and complete safety event counts. Potential publication or selection biases in trial inclusion should be checked in the full text. |
Harms, equity, conflicts & implementation
| Implementation | Full-text review to extract absolute event rates, monitoring protocols (potassium monitoring frequency), contraindications, drug interactions, and safety management pathways; cost and supply assessment for drug procurement; clinician education; and local calculation of eligible population size. |
|---|---|
| Equity impact | Unclear from abstract. Equity implications depend on access to finerenone, monitoring capacity for hyperkalaemia, and whether subgroups (by race, socioeconomic status, or care settings) experienced different benefits or harms; full-text subgroup and demographic data needed. |
| Harms | Abstract reports increased hyperkalaemia with finerenone; absolute counts and severity distribution are not provided in the abstract and require full-text verification. Monitoring requirements and resource implications are unspecified in the abstract. |
| Funding | Bayer |
| Registration | PROSPERO CRD420251269149 |
| Replication | Not assessed from abstract; replication across independent datasets unknown. |
Source links — verify original
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