Low-dose spironolactone and cardiovascular outcomes in moderate stage chronic kidney disease: a randomized controlled trial
Primary resultResult — go to the resultHazard ratio 1.05 95% CI 0.81–1.37Authors' conclusion
In conclusion, we found that spironolactone was frequently discontinued due to safety concerns, with no evidence that it reduced cardiovascular outcomes in people with stage 3b CKD.
Study context
- Population
- Older adults with stage 3b chronic kidney disease (CKD) from English primary care (mean age 74.8 years)1,372 (96%) in primary analysis
- Participants
- 1,434 adults
- Comparison
- Spironolactone 25 mg plus usual care vs usual care alone
- Spironolactonen = 677
- Usual caren = 695reference
- Primary endpoint
- Time to first death, hospitalisation for heart disease, stroke, HF, TIA or PAD, or first onset of any listed condition not present at baseline
- Follow-up
- 3 years
Methodological detailsprospective, open, blinded endpoint
- Prospective
- Open
- Blinded endpoint
Primary result
As reported in the abstract
3 years
Hazard ratio
1.05
95% CI 0.81–1.37
Events by treatment group
Spironolactonevs Usual care
HR 1.05 (95% CI 0.81–1.37)
Safety
Discontinuation of spironolactone · within 6 months
- Stopped treatment within 6 months, mainly for prespecified safety stop criteria
- Two-thirds
- eGFR decrease meeting prespecified stop criteria
- n = 239, 35.4%
- Withdrawn due to treatment side effects
- n = 128, 18.9%
- Hyperkalemia
- n = 54, 8.0%
Original publication
Low-dose spironolactone and cardiovascular outcomes in moderate stage chronic kidney disease: a randomized controlled trial. Nat Med. Published 30 September 2024. doi:10.
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