|The following article is part of conference coverage from the 2018 AHA Scientific Sessions in Chicago, Illinois.The Cardiology Advisor’s staff will be reporting breaking news associated with research conducted by leading experts in cardiology. Check back for the latest news from AHA 2018.|
CHICAGO — A sacubitril–valsartan therapy regimen was associated with greater reductions in the N-terminal pro–B-type natriuretic peptide (NT-proBNP) concentrations in patients with heart failure (HF) and reduced ejection fraction (HFrEF) compared with enalapril, according to research presented at the AHA Scientific Sessions 2018 held November 10-12, 2018, in Chicago, Illinois, and simultaneously published in the New England Journal of Medicine.2
Patients with HFrEF who were hospitalized at 129 different sites in the United States for acute decompensated HF were enrolled in the PIONEER-HF study (ClinicalTrials.gov Identifier: NCT02554890, N=881).
Investigators randomly assigned patients to receive either a twice-daily regimen of 97 mg sacubitril plus 103 mg valsartan (n=440) or twice-daily 10 mg enalapril (n=441). The time-averaged proportional change in the NT-proBNP concentration through 4 weeks and 8 weeks from baseline comprised the primary outcome. Safety was also assessed, including rates of worsening renal function, symptomatic hypotension, angioedema, and hyperkalemia.
Compared with the enalapril group, a greater reduction in the time-averaged NT-proBNP concentration from baseline to 4- and 8-week follow-up was seen in patients randomly assigned to receive the sacubitril-valsartan regimen (−25.3% vs −46.7%, respectively).
In addition, there was a significantly greater ratio of change with sacubitril–valsartan compared with enalapril (0.71; 95% CI, 0.63-0.81; P <.001).
Researchers observed the greater NT-proBNP concentration reduction with sacubitril–valsartan vs enalapril by week 1 of therapy (ratio, 0.76; 95% CI, 0.69-0.85).
No differences were found between the 2 groups with regard to any of the assessed safety outcomes including angioedema (relative risk [RR], 0.17; 95% CI, 0.02-1.38), hyperkalemia (RR, 1.25; 95% CI, 0.84-1.84), and worsening renal function (RR, 0.93; 95% CI, 0.67-1.28).
According to the investigators, the results of their trial “extend the evidence base regarding the use of sacubitril–valsartan to populations for which there had been limited or no data, including patients who are hospitalized for acute decompensated heart failure, patients who have new heart failure, and patients who have not been exposed to high doses of guideline-directed medications for heart failure or are not receiving conventional renin–angiotensin system inhibitors.”
Disclosures: The PIONEER-HF clinical trial was funded by Novartis. Please refer to original reference for full list of authors disclosures.
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Velazquez EJ, Morrow DA, DeVore AD, et al. Angiotensin–neprilysin inhibition in acute decompensated heart failure [published online November 11, 2018]. NEJM. doi:10.1056/NEJMoa1812851