Contributor: Nicholas Hawkes
Quality not quantity. Why not both? It is established that sacubitril/valsartan is superior to enalapril (or dose-equivalent ACE-I) when it comes to mortality and morbidity in HFrEF. But what about quality of life (QoL)? Patients enrolled in PARADIGM-HF had increased quality of life when randomized to sacubitril/valsartan.
In the 8399 HFrEF patients of the PARADIGM-HF study, 7623 patients completed the Kansas City Cardiomyopathy Questionnaire (KCCQ) at multiple time points. This well-validated tool measures health related quality of life. The KCCQ assessment reflected improved in quality of life for patients on sacubitril/valsartan compared to dose-equivalent ACE-I. Worth mentioning, the first KCCQ was administered 5-10 weeks after randomization, following the “run-in” period after which patients were randomized in a blinded fashion to either enalapril BID or sacubitril/valsartan.
Changes in the clinical summary score (KCCQ-CS) and overall score (KCCQ-OS) were assessed between randomization and 8 months. In a multivariable model, randomization to sacubitril/valsartan remained an independent predictor of QoL improvement.
QoL scores were high in this study. The higher scores may reflect the unique study schedule of the PARADIGM-HF in that the first KCCQ survey was given following the run-in phase. Further, it is known that health related QoL perceptions can improve in the setting of a clinical trial.