Post-hoc analysis of PARADIGM-HF study shows Entresto (sacubitril/valsartan) improves glycemic control in patients with heart failure- Novartis

Novartis announced results of a new post-hoc analysis in a subgroup of patients with reduced ejection fraction heart failure (HFrEF) or systolic heart failure (HF) and diabetes suggesting that Entresto (sacubitril/valsartan) tablets improved glycemic control, as assessed by hemoglobin A1c (HbA1c) testing, compared to ACE-inhibitor enalapril. Entresto is not currently indicated to treat diabetes. Entresto lowered HbA1c levels - a measure of average blood glucose levels for the past two to three months - after one year of treatment for HF, and this effect was sustained over three years of study follow-up. Entresto decreased HbA1c levels by 0.26% during the first year of follow-up, compared to a 0.16% reduction with enalapril. Over three years, HbA1c levels remained persistently lower in patients treated with Entresto compared to enalapril, with an overall reduction of 0.14%. In addition, 29% fewer Entresto-treated patients initiated insulin therapy to achieve glycemic control (114 (7%) vs. 153 (10%) patients). Entresto was shown to reduce the risk of CV death or HF hospitalization compared with enalapril among patients with or without diabetes at baseline.

In the analysis, new use of insulin therapy or oral diabetes agents was also reduced in the Entresto group. This analysis suggests that, in addition to the heart failure benefits demonstrated in PARADIGM-HF, Entresto may also help tighten glycemic control among heart failure patients with diabetes. The findings are based on data from PARADIGM-HF, the largest clinical trial ever conducted in HF, and are simultaneously being presented at the American College of Cardiology (ACC) 66th Annual Scientific Session and published in The Lancet Diabetes & Endocrinology.