Patients with HF similar to those in the PARADIGM-HF trial have a projected increase in life expectancy of approximately 1.5 years if they receive sacubitril/valsartan compared with enalapril, according to new data published in The New England Journal of Medicine.
Scott D. Solomon, MD, director of noninvasive cardiology at Brigham and Women’s Hospital and professor of medicine at Harvard Medical School, and colleagues conducted an analysis of patients with HF from the PARADIGM-HF trial to predict the long-term treatment effects of sacubitril/valsartan (Entresto, Novartis) compared with the ACE inhibitor enalapril.
Scott D. Solomon
Based on the results of PARADIGM-HF, sacubitril/valsartan, an angiotensin receptor-neprilysin inhibitor, was approved by the FDA in July for reduction of CV death and HF-related hospitalization in patients with HF with reduced ejection fraction.
Using data from the study on age at randomization and age at event rates, the researchers constructed actuarial estimates of age-specific event rates and survival times, which were validated by comparing similar estimates from the SOLVD-Treatment trial.
Solomon and colleagues estimated that a 55-year-old patient similar to participants in the PARADIGM-HF trial would have a projected life expectancy of 12.9 years on sacubitril/valsartan vs. 11.6 years on enalapril (mean benefit, 1.4 years; 95% CI, –0.1 to 2.8), and that a 65-year-old patient of a similar profile would have a projected life expectancy of 11.4 years on sacubitril/valsartan vs. 10 years on enalapril (mean benefit, 1.3 years; 95% CI, 0.3-2.4).
“These results help both patients and physicians understand the impact of switching from the standard of care to sacubitril/valsartan, in terms of a benefit they can easily understand,” Solomon said in a press release. “Patients want to know how much longer they are going to live, rather than how much their risk will be reduced.”
The researchers also noted that a 55-year-old patient such as those in PARADIGM-HF is projected to be free from the study’s primary endpoint of CV death or HF hospitalization for 9.6 years on sacubitril/valsartan vs. 7.4 years on enalapril (mean benefit, 2.1 years; 95% CI, 1-3.3), and the figures for a comparable 65-year-old are 9.2 years on sacubitril/valsartan vs. 7.6 years on enalapril (mean benefit, 1.6 years; 95% CI, 0.7-2.5). – by Erik Swain
Disclosure: PARADIGM-HF was funded by Novartis. Solomon reports receiving grants and personal fees from Novartis. See the full article for a list of the other authors’ relevant financial disclosures.