HbA1c Does Not Influence CV Effects of Empagliflozin

The cardiovascular (CV) benefits associated with empagliflozin use among patients with type 2 diabetes and established CV disease is not influenced by baseline hemoglobin A_1c (HbA_1c) or by patients’ early glycemic response to treatment, according to a recent study.

Study findings were presented on September 12, 2017, at the European Association for the Study of Diabetes (EASD) 53rd Annual Meeting 2017 in Lisbon, Portugal.
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Results from the Empagliflozin, Cardiovascular Outcomes, and Mortality in Type 2 Diabetes trial (EMPA-REG OUTCOME) had indicated that empagliflozin had reduced the risk of CV death by 38% vs placebo in people with type 2 diabetes and established CV disease. However, it has not been established whether this decrease was influenced by baseline HbA_1c or change in HbA_1c.

To explore this potential association, the researchers assessed 7020 patients with type 2 diabetes and established CV disease. Patients were randomly assigned to receive 10 mg empagliflozin, 25 mg empagliflozin, or placebo. Background glucose-lowering therapy remained unchanged for 12 weeks and was subsequently adjusted based on local guidelines to achieve glycemic control. Follow-up lasted a median 3.1 years.

CV death was assessed via pooled data from both the empagliflozin and the placebo groups. Data on baseline HbA_1c was categorized in subgroups of less than 7%, 7% to less than 8%, 8% to less than 9%, and 9% or above. Additionally, data on the reduction in HbA_1c from baseline to week 12 was categorized by reductions of 0.5% or more, or by less than 0.5%. A Cox proportional hazards model was used to evaluate the differences in risk between each group.

Ultimately, results indicated that the CV benefits associated with empagliflozin vs placebo at week 12 were not influenced by baseline HbA_1c or change in HbA_1c from baseline.

“In patients with [type 2 diabetes mellitus] and established CV disease, the reduction in CV death with empagliflozin appeared to occur irrespective of either baseline HbA_1c or the early glycemic response to the medication,” the researchers concluded.

—Christina Vogt

Reference:

Inzucchi SE, Fitchett D, Wanner C, et al. Does baseline HbA_1c or change in HbA_1c predict the reduction in cardiovascular (CV) death with empagliflozin? Results from EMPA-REG OUTCOME. Paper presented at: European Association for the Study of Diabetes (EASD) 53rd Annual Meeting 2017; September 11-15, 2017. Lisbon, Portugal. http://www.abstractsonline.com/pp8/#!/4294/presentation/5367. Accessed on September 18, 2017.