Interim analysis of CHAMP-HF registry shows chronic heart failure patients on Entresto demonstrate improved health.- Novartis.

Novartis announced new real world evidence from a pre-specified analysis of an interim data cut from the CHAMP-HF registry comparing Entresto (sacubitril/valsartan) patients to patients not taking Entresto in chronic heart failure (HF) patients with reduced ejection fraction (HFrEF). The data showing that those taking Entresto reported early, statistically significant improvement in health status, as measured by the KCCQ-12 overall summary score (KCCQ-OS).

Patients taking Entresto had statistically significant improvement in health status as measured by the mean group difference in KCCQ overall summary score (KCCQ-OS) compared to those not taking Entresto (6.01±19 vs. 3.55±17). This improvement in the KCCQ score was seen early with a median follow up of 32 days reported. Patients on Entresto scored numerically higher on all domains compared to patients not taking Entresto, but the improvement in the KCCQ-OS score was driven by statistically significant improvements in two domains: symptom frequency (5.07 vs. 1.60) and quality of life (7.53 vs. 4.09). The proportion of patients with a large improvement in overall score (defined as a greater than 20-point improvement from baseline) was 21.4% (78 out of 365 patients) for those taking Entresto vs. 12.5% (91 out of 730 patients) for those not taking Entresto, suggesting a number needed to treat (NNT) of 11.

The overall findings of this real world matched analysis are in line with the KCCQ findings in the PARADIGM-HF study, which showed that Entresto had a positive impact on the health status of patients with chronic heart failure. The study findings were presented at the European Society of Cardiology Heart Failure (ESC-HF) Congress.