EAST HANOVER, N.J. — A post-hoc analysis in a subgroup of patients with reduced ejection fraction heart failure (HFrEF) and diabetes suggest that Entresto (sacubitril/valsartan) tablets improved glycemic control, as assessed by hemoglobin A1c (HbA1c) testing, compared to ACE-inhibitor enalapril.
According to Novartis, which funded the study, FDA-approved Entresto lowered HbA1c levels — a measure of average blood glucose levels for the past two to three months — after one year of treatment for heart failure, and this effect was sustained over three years of study follow-up. In the analysis, new use of insulin therapy or oral diabetes agents was also reduced in the Entresto group. The analysis was presented at the American College of Cardiology 66th Annual Scientific Session & Expo in Washington, D.C. and published in The Lancet Diabetes & Endocrinology.
"Diabetes is a major risk factor in heart failure and is strongly linked to progression of the disease, putting heart failure patients at increased risk of hospitalization and death," said Scott Solomon, MD, Director of Noninvasive Cardiology, Brigham and Women's Hospital, Professor of Medicine, Harvard Medical School, and senior author of the publication. "This analysis suggests that, in addition to the proven heart failure benefits demonstrated in PARADIGM-HF, Entresto may also help tighten glycemic control among heart failure patients with diabetes."
An analysis was conducted of 3,778 HFrEF patients in the PARADIGM-HF trial who were diagnosed with diabetes or had a baseline HbA1c ≥ 6.5% without a reported diagnosis at screening (98% of patients assessed had type 2 diabetes). The investigators compared the effects of Entresto vs. enalapril on glycemic control by measuring patients' HbA1c levels at screening and at one-, two-, and three-year follow-up visits, and by evaluating patients' initiation of oral antihyperglycemic or insulin therapy during the study.
This post-hoc analysis found that Entresto decreased HbA1c levels by 0.26% during the first year of follow-up, compared to a 0.16% reduction with enalapril (p=0.0023)
"On top of the already well-demonstrated clinical benefits of Entresto, a reduction in HbA1c levels in these type 2 diabetes patients is of great interest and shows us that further research is needed to better understand this metabolic effect of the drug," said Fabrice Chouraqui, President of Novartis. "Novartis is committed to exploring the full potential of this important medication to maximize its value for heart failure patients managing their chronic condition."
Heart failure is a debilitating and life-threatening condition, which impacts 6.5 million Americans and is the leading cause of hospitalization among Americans over the age of 65.