Cardiometabolic & kidneyRandomised controlled trial
Low-dose spironolactone and cardiovascular outcomes in moderate stage chronic kidney disease: a randomized controlled trial
- Randomised controlled trial
- prospective
- open
- blinded endpoint
Authors' 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
Primary result
As reported in the abstract
3 years
Hazard ratio
1.05
95% CI 0.81–1.37
Events by treatment group
Spironolactone vs 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- Withdrawn due to treatment side effects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:10.1038/s41591-024-03263-5
Summarised from the published abstract; every number is checked against it