medwireNews: Analysis of data from the EMPA-REG OUTCOME trial suggests that empagliflozin reduces the risk for cardiovascular mortality in patients with type 2 diabetes irrespective of baseline glycated hemoglobin (HbA1c) levels or glycemic response.
Presenting the results at the 2018 Diabetes UK Professional Conference in London, Jyothis George (Boehringer Ingelheim Pharma GmbH & Co, Germany) told delegates that 3.7% of 4687 patients who were randomly assigned to receive empagliflozin died due to cardiovascular causes, compared with 5.9% of the 2333 given placebo, giving a significant hazard ratio (HR) of 0.62 in favor of empagliflozin.
In the current post-hoc analysis, rates of cardiovascular mortality remained significantly lower in the empagliflozin than in the placebo group among patients with HbA1c levels below 7% (2.4 vs 7.9%), 7–8% (3.7 vs 6.1%), and 8–9% (3.7 vs 5.4%), with HRs of 0.30, 0.59, and 0.67, respectively.
For patients with baseline HbA1c levels of 9% or over, those given empagliflozin had numerically lower rates of cardiovascular death than placebo-treated participants, but the difference did not reach statistical significance.
George explained that the test for interaction between treatment and subgroup did not reach statistical significance, demonstrating that “baseline HbA1c did not have a significant impact on cardiovascular outcomes.”
Similarly, when the researchers divided participants into subgroups based on change in HbA1c levels, they observed “remarkable consistency” with the primary trial results, he said.
Indeed, rates of cardiovascular mortality for patients treated with empagliflozin versus placebo were 2.9% versus 5.1% among those with a reduction in HbA1c levels of at least 0.5% from baseline to week 12 (HR=0.57). The corresponding rates were 4.4% versus 5.6% among those with a reduction of less than 0.5% or an increase in HbA1c levels (HR=0.75), and the p value for interaction was not statistically significant.
And these findings remained consistent when patients were categorized based on HbA1c reductions of at least versus less than 0.3%, and when the median change was used as a cutoff.
“It is reassuring to see, despite the HbA1c change, that we still see consistency in [cardiovascular] outcomes,” concluded George.
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