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Published on: September 17, 2015
Sacubitril/Valsartan versus Enalapril or Losartan at Maximum Doses in Heart Failure with Reduced Ejection Fraction:
Renato de Carvalho Barros1, Vinícius C Fiusa2,3, Gabrielle N Tim4
1Universidade de Brasília - Faculdade de Ciências Médicas, Brasília, DF - Brasil.
Background:
Sacubitril/valsartan reduced mortality and hospitalizations in patients with heart failure with reduced ejection fraction (HFrEF) compared to enalapril in pivotal clinical trials. However, real-world data under optimized dosing remain limited.
Objective:
To compare the outcomes of HFrEF patients treated with sacubitril/valsartan versus either enalapril or losartan at guideline-recommended maximum dosages.
Methods:
We analyzed data from an observational heart failure cohort (n = 2,314) including patients receiving care between August 2010 and September 2024 at six public hospitals in a large metropolitan area. The primary analysis included 254 HFrEF patients receiving the guideline-recommended maximum dosages of the investigated drugs. A sensitivity analysis included 452 patients receiving any submaximal dosages. The primary outcome was combined hospitalization or death. Baseline differences were adjusted using propensity score matching. A p-value < 0.05 was considered significant.
Results:
Among 254 HFrEF patients (mean age 63.6 ± 12.3 years, 61.4% male), 115 received sacubitril/valsartan 97/103mg twice daily, 33 enalapril 20 mg twice daily, and 106 losartan 100 mg daily. Over the median follow-up of 23.9 months (interquartile range 11.9-41.1), there were 70 primary endpoint events (56 first hospitalizations, 32 deaths). Compared to equivalent dosages of enalapril or losartan, sacubitril/valsartan was not associated with significant reductions in combined hospitalization or death (odds ratio 0.650, 95% confidence interval 0.354-1.195, p = 0.165), but it was associated with functional status improvement (odds ratio 3.902, 95% confidence interval 1.745-8.726, p = 0.001).
Conclusion:
This real-world study did not demonstrate significant reductions in hospitalization or mortality for sacubitril/valsartan compared with enalapril or losartan at guideline-recommended maximum dosages; however, sacubitril/valsartan was associated with improved functional status.
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