MONDAY, Nov. 15, 2021 (HealthDay News) -- For patients with chronic advanced heart failure with a reduced ejection fraction, sacubitril/valsartan shows no benefit over valsartan, according to a study published online Nov. 3 in JAMA Cardiology to coincide with the American Heart Association Scientific Sessions 2021, held virtually from Nov. 13 to 15.
Douglas L. Mann, M.D., from Washington University in St. Louis, and colleagues conducted a double-blind randomized clinical trial involving 335 patients with advanced heart failure. Participants were randomly assigned to receive sacubitril/valsartan or valsartan in addition to recommended therapy. The main outcome was the area under the curve (AUC) for the ratio of N-terminal pro-brain natriuretic peptide (NT-proBNP) measured through 24 weeks of therapy compared to baseline.
The researchers found that the median NT-proBNP AUC was 1.19 (interquartile range, 0.91 to 1.64) for the 168 participants in the valsartan treatment arm and 1.08 (interquartile range, 0.75 to 1.60) for the 167 participants in the sacubitril/valsartan treatment arm, yielding an estimated ratio of change in NT-proBNP AUC of 0.95 (95 percent confidence interval, 0.84 to 1.08; P = 0.45). Treatment with sacubitril/valsartan did not improve the clinical composite of number of days alive, out of hospital, and free from heart failure events compared with valsartan. No safety events were observed aside from a significant increase in non-life-threatening hyperkalemia in the sacubitril/valsartan arm.
"The evidence suggests that sacubitril/valsartan helps heart failure patients with mild or moderate heart failure but is no better than valsartan for patients with severe disease," Mann said in a statement.
Several authors disclosed financial ties to pharmaceutical companies, including Novartis, which provided the study drug and partial funding.
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