Key result
Sacubitril/valsartan discontinuation in patients with heart failure and reduced ejection fraction was associated with increased all-cause mortality (HR 13.51; 95% CI 3.22-56.13; P<0.001).
Why the study?
Sacubitril/valsartan was a new therapy in heart failure with reduced ejection fraction, but its efficacy and safety in daily clinical practice needed evaluation.
Does sacubitril/valsartan discontinuation increase mortality in outpatients with heart failure with reduced ejection fraction?
Observational (n=427)
Yes
Does sacubitril/valsartan discontinuation increase mortality in outpatients with heart failure with reduced ejection fraction?
Hazard Ratio: 13.51 (95% CI 3.22–56.13)
p-value: p=<0.001
In a real-world registry, sacubitril/valsartan was well tolerated, and its discontinuation was strongly associated with increased mortality and lack of clinical improvement.
Discontinuation of sacubitril/valsartan warrants caution in HFrEF outpatients; leaves open causality and requires prospective confirmation.
Sacubitril/valsartan (SV) is a new therapy in heart failure with reduced ejection fraction. Our aim was to determine the efficacy and safety of this drug daily clinical practice. We performed a multicenter registry in 10 hospitals. All patients who started SV from October 2016 to March 2017 on an outpatient basis were included. A total of 427 patients started treatment with SV. Mean follow-up was 7.0 ± 0.1 months. Forty-nine patients (11.5%) discontinued SV, and 12 (2.8%) died. SV discontinuation was associated with higher cardiovascular (hazard ratio 13.22, 95% confidence interval, 6.71-15.73, P < 0.001) and all-cause mortality (hazard ratio 13.51, 95% confidence interval 3.22-56.13, P < 0.001). Symptomatic hypotension occurred in 71 patients (16.6%). Baseline N-terminal pro-B-type natriuretic peptide levels, functional class, and left ventricular ejection fraction improved at the end of follow-up in patients who continued with SV (all P values ≤0.001). This improvement was not significant in patients with SV discontinuation. SV has a good tolerability in patients from daily clinical practice. SV withdrawal in patients with heart failure and reduced ejection fraction was independently associated with increased all-cause mortality. Patients who continued with SV presented an improvement in functional class left ventricular ejection fraction and N-terminal pro-B-type natriuretic peptide levels.
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Vicent et al. (2018) conducted an observational in Heart failure with reduced ejection fraction (n=427). Sacubitril/valsartan discontinuation vs. Sacubitril/valsartan continuation was evaluated on All-cause mortality (HR 13.51, 95% CI 3.22-56.13, p=<0.001). Sacubitril/valsartan discontinuation in patients with heart failure and reduced ejection fraction was associated with increased all-cause mortality (HR 13.51; 95% CI 3.22-56.13; P<0.001).
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