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HF therapy yields favorable effects on glycemic control
WASHINGTON — In the PARADIGM-HF trial, patients with HF with reduced ejection fraction and diabetes who were treated with combination sacubitril/valsartan experienced greater reductions in HbA1c levels and use of diabetes therapies, compared with the ACE inhibitor enalapril.
Results of a post-hoc analysis of 3,778 participants of the PARADIGM-HF trial with HF with reduced ejection fraction (HFrEF) and either diagnosed diabetes or HbA1c 6.5% at screening were presented at the American College of Cardiology Scientific Session. The analysis compared the effects of sacubitril/valsartan (Entresto, Novartis) vs. enalapril on glycemic control by measuring patients’ HbA1c levels at screening and at 1-, 2- and 3-year follow-up visits and by evaluating patients’ initiation of oral antihyperglycemic or insulin therapy. Ninety-eight percent of patients had type 2 diabetes.
“Sacubitril/valsartan has been shown to reduce CV death, HF hospitalizations and all-cause mortality compared with the ACE inhibitor enalapril in PARADIGM-HF, the largest study of HFrEF. We evaluated the effects of sacubitril/valsartan on glycemic control in patients with diabetes enrolled in PARADIGM-HF. ... We found that those patients randomized to sacubitril/valsartan had significantly lower HbA1c in follow-up than those randomized to enalapril, and that they also had a highly significant 29% greater reduction in new use of insulin,” Scott D. Solomon, MD, professor of medicine, Harvard Medical School, Brigham and Women’s Hospital, said in an interview.
At 1 year, the mean decrease in HbA1c was 0.26% with sacubitril/valsartan vs. 0.16% with enalapril (P = .0023). Over 3 years, HbA1c levels remained persistently lower in patients assigned sacubitril/valsartan vs. placebo, with an overall reduction of 0.14% (95% CI, 0.06-0.23), according to a press release.
Ten percent of patients in the enalapril group initiated insulin therapy to achieve glycemic control compared with 7% in the sacubitril/valsartan group (HR = 0.71; 95% CI, 0.56-0.9), according to the release. Initiation of oral antihyperglycemic agents was also lower in the sacubitril/valsartan group (HR = 0.77; 95% CI, 0.58-1.02).
In other results, sacubitril/valsartan was associated with a reduction in the risk for CV death or HF hospitalization compared with enalapril in patients with or without diabetes at baseline, according to the release.
“These findings suggest that in patients with both HFrEF and diabetes, sacubitril/valsartan has more favorable effects on glycemic control than the ACE inhibitor enalapril. Clinicians treating diabetic patients with sacubitril/valsartan may want to be aware of this, as these patients may need their doses of anti-hyperglycemic agents adjusted,” Solomon said.
The researchers noted in The Lancet that these findings “should be considered hypothesis-generating” and that further research is needed.
“Future and ongoing studies will aim to confirm these findings and determine if patients treated with sacubitril/valsartan require lower doses of antidiabetic medications. Additional research should help elucidate mechanisms by which sacubitril/valsartan may improve glycemic control,” Solomon said. – by Regina Schaffer and Katie Kalvaitis
References:
Seferovic JP, et al. Abstract 1216M-03. Presented at: American College of Cardiology Scientific Session; March 17-19, 2017; Washington, D.C.
Seferovic JP, et al. Lancet. 2017;doi:10.1016/S2213-8587(17)30087-6.
Disclosure: Solomon reports consulting for Novartis and receiving research support from Novartis in the form of grants to his institution.