Health-related quality of life (HRQL) perceptions are predictive of future risk for morbidity and mortality [1,2]. Moreover, for many patients with HF improvement of HRQL is important.
Sacubitril/valsartan combines the neprilysine inhibitor, sacubitril, with the angiotensin receptor blocker (ARB), valsartan, and demonstrated superiority to enalapril on cardiovascular death, heart failure (HF) hospitalization and all-cause death in PARADIGM-HF [3] as well as the clinical progression of HF and risk of sudden cardiac death in patients that survived [4,5].
In this analysis of PARADIGM-HF, a comprehensive analysis of HRQL was performed to determine whether sacubitril/valsartan (LCZ696) was superior to enalapril on HRQL changes at 8 months (primary objective) and beyond 8 months (secondary objective) in HF patients with reduced ejection fraction (HFrEF). In PARADIGM-HF, all patients received enalapril for 2 weeks, followed by 4-6 weeks sacubitril/valsartan during run-in period. HRQL was based on ‘The Kansas City Cardiomyopathy Questionnaire’ (KCCQ) which contains 23 items that were self-administered at the time of randomization, after the run-in phase at 4, 8 and 12 months and annually thereafter. 3460 patients on LCZ696 completed the KCCQ scores at month 8 and 3421 patients on enalapril (together 90% of patients). This was 1087 and 1091 (29% of patients), respectively, at month 36.
In patients with HFrEF, sacubitril/valsartan was superior to enalapril in improving disease-specific HRQL in PARADIGM-HF, despite the relatively higher baseline KCCQ scores that were established after the run-in period that may have mitigated the magnitude of improvement. This difference between treatments was already noted after 4 months and persisted through month 36 and was particularly true for patients hospitalized for HF.
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