Heart failure & cardiomyopathies

Asymptomatic vs Symptomatic Hypotension With Sacubitril/Valsartan in Heart Failure and Reduced Ejection Fraction in PARADIGM-HF

J Am Coll CardiolPublished Secondary analysis of the PARADIGM-HF randomised trial

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
Methodological detailspost hoc analysis, time-updated Cox proportional hazards models
  • Post hoc analysis
  • Time-updated Cox proportional hazards models

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

Composed by AI from the published abstract and checked against it. How Briefs are made →

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