Sacubitril/valsartan appeared to improve quality of life more than enalapril in patients with heart failure and reduced ejection fraction, a recent secondary analysis of an industry-sponsored study found.
Researchers used data from the PARADIGM-HF Trial to compare the effects of sacubitril/valsartan on physical and social activities in patients with heart failure. In the PARADIGM-HF Trial, which was funded by Novartis, 8,399 patients who had New York Heart Association class II to IV disease and a left ventricular ejection fraction of 40% or less were randomly assigned to receive sacubitril/valsartan, 200 mg twice daily, or enalapril, 10 mg twice daily. At randomization, four-month, eight-month, and annual visits, patients completed health-related quality of life (HRQL) assessments with the Kansas City Cardiomyopathy Questionnaire (KCCQ). The researchers compared the effects of sacubitril/valsartan and enalapril on the physical and social limitations sections of the KCCQ at eight months as well as longitudinally. The study results were published online April 4 by JAMA Cardiology.
A total of 7,618 of 8,399 patients (90.7%) completed the initial KCCQ assessment at baseline. Of these, 5,987 were man and 1,631 were women, and the mean age was 64 years. At baseline, the greatest limitations were reported in jogging and in sexual relationships, and the fewest limitations were reported with dressing and showering. At eight months and over 36 months, patients taking sacubitril/valsartan did significantly better on most physical and social activities versus patients taking enalapril. Household chores and sexual relationships were the categories with the biggest differences at eight months (adjusted change score difference, 2.35 and 2.72, respectively; P<0.001 and P=0.002), and these effects persisted over 36 months (overall change score difference, 1.69 and 2.36, respectively; P<0.001 and P=0.001).
The researchers noted that their results were affected by missing data, that they could only evaluate HRQL at study sites where validated-language versions of the KCCQ were available, and that the results from individual items of the KCCQ should be interpreted with caution. However, they concluded that in patients with heart failure and reduced ejection fraction, a significant improvement was seen in limitations of physical and social activity with sacubitril/valsartan versus enalapril. “In addition to reduced likelihood of cardiovascular death, all-cause mortality, and heart failure-associated hospitalization, sacubitril/valsartan may improve limitations in physical and social activities that are important to patients with heart failure,” the researchers wrote.