Heart failure & cardiomyopathiesSecondary analysis
Asymptomatic vs Symptomatic Hypotension With Sacubitril/Valsartan in Heart Failure and Reduced Ejection Fraction in PARADIGM-HF
- Secondary analysis of the PARADIGM-HF randomised trial
- post hoc analysis
- time-updated Cox proportional hazards models
Authors' conclusion
Although both asymptomatic and symptomatic hypotension during treatment with sacubitril/valsartan or enalapril were associated with worse outcomes, the benefits of sacubitril/valsartan were maintained (or even enhanced) in patients experiencing hypotension.
Study context
- Population
- Patients with HFrEF in PARADIGM-HF, by no, asymptomatic or symptomatic hypotension after randomisation
- Participants
- 8,399 patients
- Comparison
- Sacubitril/valsartan vs enalapril, by hypotension during treatment
- Primary endpoint
- CV death or heart failure (HF) hospitalisation
Primary result
As reported in the abstract
CV death or HF hospitalisation, by hypotension subgroup
Sacubitril/valsartan vs EnalaprilHazard ratio (95% CI)
no hypotension
0.80(0.72–0.89)
asymptomatic hypotension
0.87(0.70–1.08)
symptomatic hypotension
0.51(0.38–0.69)
Further findings
Hypotension incidence after randomisation
- Only asymptomatic hypotension
- 1,343 (16.0%)
- Symptomatic hypotension at least once
- 936 (11.1%)
Outcomes by hypotension
- Either type of hypotension associated with higher risk for all outcomes examined
- Benefit of sacubitril/valsartan also not diminished for CV and all-cause death
Safety
Safety and treatment discontinuation
- Safety of sacubitril/valsartan vs enalapril maintained regardless of hypotension
- Discontinuation less common with sacubitril/valsartan in patients with asymptomatic and symptomatic hypotension
Original publication
Asymptomatic vs Symptomatic Hypotension With Sacubitril/Valsartan in Heart Failure and Reduced Ejection Fraction in PARADIGM-HF. J Am Coll Cardiol. Published 25 September 2024. doi:10.1016/j.jacc.2024.08.012
Summarised from the published abstract; every number is checked against it