LIFE trial 2021 (Entresto in advanced HF with reduced EF)

 Among patients with advanced heart failure with reduced ejection fraction (HFrEF), the combination of sacubitril and valsartan was not found to be superior to valsartan in terms of lowering NT-proBNP, and it did not enhance any of the other clinical outcomes studied.


The multicenter trial assigned 335 HFrEF patients to one of two treatment groups: sacubitril/valsartan (n=167) or valsartan (n=168). The patients were followed for 24 weeks. EF was less than 20% at baseline, systolic blood pressure was approximately 113 mm Hg, estimated glomerular filtration rate was 63.6 mL/min/1.73m2 in the combination arm and 65.7 mL/min/1.73m2 in the valsartan arm, and NT-proBNP levels were 1,931 pg/ml and 1,818 pg/ml in the respective arms, respectively. The majority of the patients (60 percent) were Caucasian, 60 years old, and almost one-third were female.


Because of the significant risk of poor results in this susceptible demographic during the COVID-19 pandemic, the experiment was terminated early, in March 2020. 


Neither treatment strategy resulted in a decrease in median NT-proBNP below the baseline level, according to the findings. For the secondary efficacy objective of days alive, out of the hospital, or free of heart failure events, there was no difference between sacubitril/valsartan and valsartan (103.2 days alive, 111.2 days out of the hospital, and free of heart failure events, respectively; p=0.45).


The average daily dose of sacubitril/valsartan was 195.3 mg, while the average daily dose of valsartan was 154.4 mg, according to the tolerability endpoints (both reached only 48 percent of the target dose). In the sacubitril/valsartan and valsartan groups, hypotension occurred in 17 percent and 12 percent of the participants, respectively (p=0.16), and hyperkalemia occurred in 17 percent and 9 percent of the participants, respectively (p=0.035). In both groups, a decrease in renal function was observed in 4% of the participants.


Compared with valsartan, no improvement was observed in the following key tertiary clinical outcomes: cardiovascular death or heart failure hospitalization (hazard ratio [HR], 1.32; p=0.20); heart failure hospitalization (HR, 1.24; p=0.33); cardiovascular death or all-cause death (HR, 1.24; p=0.33); and cardiovascular death or all-cause death.


Take home: 

More information on sacubitril/valsartan ! The medicine certainly did not work in this situation in patients with severe heart failure with decreased ejection fraction (HFrEF) and comorbidities. Despite the fact that the trial was "negative," it offered crucial information on the patients who should not be given the drugs.

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