Physicians' Academy for Cardiovascular Education

ARNI treatment improves quality of life in HFrEF patients

Effects of Sacubitril/Valsartan on Physical and Social Activity Limitations in Patients With Heart Failure: A Secondary Analysis of the PARADIGM-HF Trial

Literature - Chandra A, Lewis EF, Claggett BL, et al. - JAMA Cardiol. 2018; published online ahead of print

Introduction and methods

PARADIGM-HF (Prospective Comparison of ARNI With an ACE-Inhibitor to Determine Impact on Global Mortality and Morbidity in Heart Failure) was a randomized, double-blind, active treatment–controlled, clinical trial that enrolled patients ≥18 years with heart failure (HF) and left ventricular ejection fraction (LVEF) ≤40%, NYHA class II-IV, and elevated biomarkers, or a HF-associated hospitalization within 12 months before enrollment [1].

Patients were randomized to enalapril 10mg twice daily, or sacubitril/valsartan 200mg twice daily, in a 1:1 ratio, after a run-in phase to test for intolerance. PARADIGM-HF showed that sacubitril/valsartan, compared with enalapril, significantly reduced CV mortality, HF-associated hospitalization (HFH), and all-cause mortality in patients with HF and reduced LVEF [2]. Health-related quality of life (HRQL) was also assessed, using the Kansas City Cardiomyopathy Questionnaire (KCCQ) [3].

In this secondary analysis of the PARADIGM-HF data, individual physical and social activity items in the KCCQ domains were evaluated, in order to assess the responsiveness of each individual activity to sacubitril/valsartan. The KCCQ is a 23-item, disease-specific questionnaire, which was answered 6 times during the study and was used to assess HRQL at 8 months. Patient’s responses were scaled from 0 to 100, with 0 indicating extremely or severely limited and 100 indicating not at all limited [4].

Main results

Sacubitril/valsartan was also significantly associated with an improvement of the following activities:

Improvement in combined physical and social activity during 8 months was associated with reduced risk of the primary composite end point of CV death or first HFH (HR: 0.79; 95%CI: 0.70-0.90).

Conclusion

In patients with heart failure and reduced ejection fraction, sacubitril/valsartan significantly improved limitations in physical and social activities compared with enalapril, with the largest response seen in household chores and sexual relationships.

References

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Find this article online at JAMA Cardiology