Heart failure, the leading cause of hospitalization for Americans over the age of 65, accounts for more than one million hospitalizations in the US each year. Nearly six million Americans have heart failure, about half of whom have the reduced ejection fraction form, a reduced capability to pump blood from the heart. Heart failure patients with a reduced capability to pump blood from the heart have a marked increased risk for further cardiac events and death.
New research from Brigham and Women's Hospital finds that heart failure patients with reduced ejection fraction who are treated with sacubitril-valsartan have a projected increased life expectancy of one and a half to two years, as compared to those treated with enalapril, the current standard of care in heart failure. These findings are published in the December 3 issue of the New England Journal of Medicine.
"These results help both patients and their physicians understand the impact of switching from the standard of care to sacubitril-valsartan, in terms of a benefit that they can easily understand," said Scott D. Solomon, MD, senior author and director of Non-Invasive Cardiology at Brigham and Women's Hospital (BWH) and Professor of Medicine at Harvard Medical School. "Patients want to know how much longer they are going to live, rather than how much their risk will be reduced."
In this new analysis, researchers examined data from 8,399 patients in the PARADIGM-HF study, the largest clinical trial ever conducted in heart failure, and used actuarial methods that are typically used by the insurance industry, to measure the estimated lifetime benefits of treatment with sacubitril-valsartan as determined by age-specific cardiovascular events. Researchers derived expected survival times using data from the beginning of the study and the age at the time of a cardiovascular event. An average duration of event-free survival was estimated using long-term follow up data from the clinical trial.
Assuming that the protective effects of sacubitril-valsartan remain consistent with long-term use, researchers estimated that the benefits were similar across a wide range of ages. Specifically, patients 45-75 years old using sacubitril-valsartan had a projected extended benefit of one to two years of increased life expectancy, free from heart failure hospitalization, when compared to patients of the same age who were treated with enalapril.
The PARADIGM-HF trial was supported by Novartis. Novartis manufactures sacubitril-valsartan under the brand name, Entresto ™.
About PARADIGM-HF
The PARADIGM-HF trial previously showed that sacubitril-valsartan was superior to enalapril in reducing the rates of hospitalization for heart failure, death from cardiovascular causes, and death from any cause among heart failure patients with a reduced capability to pump blood from the heart (ejection fraction). Sacubitril-valsartan was shown in PARADIGM-HF to reduce cardiovascular death or heart failure hospitalization by 20 percent, and also improved overall survival by 16 percent, versus enalapril. The study was stopped early by the Data Monitoring Committee overseeing the study because of overwhelming benefit in patients treated with sacubitril-valsartan. The primary results of the PARADIGM-HF trial were published in The New England Journal of Medicine in 2014.