Secondary analysis
Variation in Renal Function Following Transition to Sacubitril/Valsartan in Patients With Heart Failure
- Secondary analysis of the PARADIGM-HF and PARAGON-HF randomised trials
- run-in phases
Authors' conclusion
Moderate eGFR decline when transitioning from RASi to sacubitril/valsartan is not consistently associated with adverse outcomes, and its long-term benefits are retained in heart failure across a broad range of eGFR declines.
Study context
- Population
- Patients with HF in PARADIGM-HF and PARAGON-HF
- Comparison
- Sacubitril/valsartan vs renin-angiotensin system inhibitor (RASi), by run-in estimated glomerular filtration rate (eGFR) decline
- Primary endpoint
- Primary outcomes of each trial, by occurrence of eGFR decline (>15%) during sacubitril/valsartan run-in
Primary result
As reported in the abstract
Primary outcome, by run-in eGFR decline (subgroups)
Sacubitril/valsartan vs RASiEstimate (95% CI)
PARADIGM-HF, eGFR decline
HR 0.69(0.53–0.90)
PARADIGM-HF, no eGFR decline
HR 0.80(0.73–0.88)
PARAGON-HF, eGFR decline
RR 0.84(0.52–1.36)
PARAGON-HF, no eGFR decline
RR 0.87(0.75–1.02)
Further findings
eGFR decline (>15%) during sacubitril/valsartan run-in
- PARADIGM-HF
- 11%
- PARAGON-HF
- 10%
eGFR recovery · nadir to postrandomization week 16
- eGFR partially recovered regardless of sacubitril/valsartan continuation or switch to RASi
Clinical outcomes by initial eGFR decline
- Initial eGFR decline not consistently associated with clinical outcomes in either trial
- Treatment effect of sacubitril/valsartan consistent across a range of eGFR declines
Original publication
Variation in Renal Function Following Transition to Sacubitril/Valsartan in Patients With Heart Failure. J Am Coll Cardiol. Published 20 February 2023. doi:10.1016/j.jacc.2023.02.009
Summarised from the published abstract; every number is checked against it