Heart failure patients receiving sacubitril/valsartan have reduction in 30-day readmissions

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Patients with heart failure and reduced ejection fraction who received sacubitril/valsartan (Entresto) had a 26 percent lower rate of 30-day all-cause readmissions and a 38 percent lower rate of heart failure readmissions compared with patients who received enalapril, according to an analysis of a randomized trial.

The differences persisted at 60 days after patients were discharged from the hospital and remained consistent based on patients enrolled in the U.S. and patients who were at least 65 years old and eligible for Medicare.

Lead researcher Akshay S. Desai, MD, MPH, of Brigham and Women’s Hospital in Boston, and colleagues published their results online in the Journal of the American College of Cardiology on July 19.

“These data suggest that [sacubitril/valsartan] is likely to be more effective than enalapril in reducing the risk of early readmission after [heart failure] hospitalization,” they wrote

The researchers mentioned that approximately 25 percent of patients with heart failure who are older than 65 are readmitted to the hospital within 30 days and nearly 50 percent are readmitted within six months.

In July 2015, the FDA approved sacubitril/valsartan, a twice-daily oral medication to treat patients with New York Heart Association (NYHA) class II to IV heart failure. The approval was based on the PARADIGM-HF trial, which found that patients treated with sacubitril/valsartan had a 20 percent reduction in the primary composite endpoint of cardiovascular death or heart failure hospitalization compared with the enalapril group.

Earlier this month, Novartis announced it would spend an additional $200 million this year to increase sales of sacubitril/valsartan. So far, the sales of the medication have fallen below expectations, but the company still expects annual revenue from the drug to top $1 billion.

In this analysis, the researchers further evaluated the PARADIGM-HF study, which enrolled 8,399 participants with chronic heart failure, NYHA class II to IV symptoms and left ventricular ejection fraction of 35 percent or less when treated with guideline-recommended medical therapy.

Of the patients, 19.7 percent had an investigator-reported heart failure hospitalization and 17.3 percent survived at least one heart failure hospitalization, including 16.1 percent of patients in the sacubitril/valsartan group and 18.4 percent of patients in the enalapril group.

Of the 2,383 heart failure hospitalizations, 45.2 percent occurred in the sacubitril/valsartan group and 54.8 percent occurred in the enalapril group. The length of stay during the heart failure hospitalization was 7.5 days and 7.0 days, respectively, which was not significantly different.

At 30 days, the all-cause readmission rates were 17.8 percent in the sacubitril/valsartan group and 21.0 percent in the enalapril group. The 30-day heart failure readmission rates were 9.7 percent and 13.4 percent, respectively.

At 60 days, the all-cause readmission rates were 27.8 percent in the sacubitril/valsartan group and 30.5 percent in the enalapril group. The 30-day heart failure readmission rates were 17.1 percent and 20.3 percent, respectively.

The researchers cited a few study limitations, including that this was not a pre-specified analysis of the PARADIGM-HF trial and patients were not randomized at the time of their index hospitalizations.

“Reducing early readmissions after [heart failure] hospitalization represents an opportunity to simultaneously improve patient outcomes and reduce the fiscal burden of [heart failure] management for hospitals and payers,” the researchers wrote. “These data highlighting fewer all-cause and heart-failure readmissions at 30 days during treatment with [sacubitril/valsartan] relative to enalapril provide additional rationale for use of sacubitril/valsartan in preference to enalapril in patients with chronic, symptomatic [heart failure] and reduced ejection fraction.”