Patients who took sacubitril/valsartan (Entresto, Novartis) instead of enalapril in the PARADIGM-HF trial consistently scored higher across a range of specific quality-of-life (QoL) metrics for activity and social engagement, suggests a new analysis.
Improvements over 36 months were most pronounced in domains that reflected being able to work, do household chores or recreational activities, climb stairs, and have intimate and sexual relationships.
Scott D Solomon, MD, Brigham and Women’s Hospital, Boston, Massachusetts, said the QoL analysis is a “deeper dive” compared to a prior study showing an advantage for sacubitril/valsartan on Kansas City Cardiomyopathy Questionnaire (KCCQ) summary scores in PARADIGM-HF. Those scores are composites of the instrument’s more specific QoL domains.
“Here, we looked at some of the individual components that patients really care about most, in particular, the physical and social limitations,” Solomon told theheart.org | Medscape Cardiology.
“We found that virtually all of these are significantly improved in the patients who received sacubitril/valsartan, and the ones that appeared to be most improved are household chores and sexual and intimate relationships.”
The PARADIGM-HF analysis of specific health-related QoL domains was published April 4 in JAMA Cardiology with Alvin Chandra, MD, Brigham and Women’s Hospital, as lead author and Solomon as senior author.
In the trial’s primary analysis, released in 2014, patients with NYHA class II to IV systolic heart failure assigned to sacubitril/valsartan benefited with a significantly reduced risk for cardiovascular death or heart failure hospitalization, the primary endpoint, compared with those taking enalapril. All-cause mortality was also lower with the novel agent in the trial, which had entered 8399 patients in 38 countries. Of those, 90% completed the KCCQ at randomization.
When the broad improvements in QoL domains in the current analysis were tracked by age, there was a suggestion that patients receiving sacubitril/valsartan lived life physically and socially almost a decade “younger” than those receiving enalapril.
“We know that as people age, their ability to do things goes down. What we found was a very clear relationship between age and worsening of social and physical activities,” Solomon said. That’s to be expected, but the curve reflecting those domains over time were shifted 9 years to the left for patients receiving sacubitril/valsartan.
“It’s kind of saying these patients are feeling as if they are 9 years younger,” he said.
Table. Odds Ratios for Five-Point or Greater Improvement in KCCQ Domain Scores for Sacubitril/valsartan vs Enalapril: Multivariate Analysis
| KCCQ Domain | Odds Ratio (95% Confidence Interval) | P Value |
|---|---|---|
| Walking 100 yards on level ground | 1.13 (1.03 – 1.24) | .01 |
| Gardening, housework, or carrying groceries | 1.17 (1.07 – 1.28) | .001 |
| Jogging or hurrying (as if to catch a bus) | 1.12 (1.02 – 1.24) | .02 |
| Hobbies and recreational activities | 1.16 (1.05 – 1.28) | .002 |
| Working or doing household chores | 1.20 (1.09 – 1.32) | <.001 |
| Intimate or sexual relationships | 1.18 (1.05 – 1.33) | .005 |
The study didn’t clarify how intimate or sexual relationships were improved, such as whether it was related to better sexual function or libido. It didn’t ask patients whether they were married, and the improvement was significant in both men and women. The reason may simply have been greater interest in such relationships because of improved overall well-being, Solomon said.
PARADIGM-HF was supported by Novartis. Solomon reports receiving consulting fees and research grants from Novartis. Chandra had no disclosures. Disclosures for the other authors are in the report.
JAMA Cardiol. Published online April 4, 2018. Abstract
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