EMPA-REG OUTCOME: Empagliflozin reduces total CV burden in type 2 diabetes
medwireNews: Empagliflozin reduces the total burden of cardiovascular (CV) complications and all-cause hospitalization in people with type 2 diabetes and atherosclerosis, show data from the EMPA-REG OUTCOME trial.
The primary EMPA-REG OUTCOME trial analysis found that the sodium-glucose cotransporter (SGLT)2 inhibitor empagliflozin significantly reduced the risk for a first major adverse CV event (MACE), defined as cardiovascular death, nonfatal stroke, or nonfatal myocardial infarction, in people with type 2 diabetes.
The current analysis, with approximately 3 years of follow-up, revealed that the total (first plus recurrent) MACE rate was also significantly lower for the individuals who received empagliflozin 10 mg (n=2345) or 25 mg (n=2342) once daily relative to those who received placebo (n=2333).
Specifically, the risk for total MACE was a significant 22% lower with versus without empagliflozin, which was equivalent to 12.9 events prevented per 1000 patient–years of treatment, Darren McGuire (University of Texas Southwestern Medical Center, Dallas, USA) and co-investigators report in The Lancet Diabetes & Endocrinology.
Overall, 772 (11.0%) participants had a first MACE, of whom 129 (16.7%) subsequently had a total of 164 recurrent events.
In addition, the total rate of fatal or nonfatal myocardial infarction was a significant 21% lower with versus without empagliflozin, with 5.0 events per 1000 patient–years prevented.
And the total rates of hospitalization for heart failure, myocardial infarction or coronary revascularization, and all-cause hospitalization were a significant 42%, 20%, and 17% lower among the patients who received the SGLT2 inhibitor compared with those who did not, corresponding to 9.67, 11.65, and 50.41 fewer events per 1000 person–years.
There was no significant difference between the treatment groups, however, in the rate of total fatal or nonfatal stroke.
McGuire and co-authors point out that the lower rate of hospital admissions with empagliflozin versus placebo “was apparent across most types of admission to hospital,” not just CV admissions.
They also say that each of these relative and absolute risk reductions “were of a clinically relevant magnitude and numerically larger when analysing total events as opposed to analyses restricted to first events only.”
The authors conclude: “Our results support treatment with empagliflozin to reduce the total burden of atherosclerosis-related outcomes, admission to hospital for heart failure, mortality, and all-cause admission to hospital in patients with type 2 diabetes and atherosclerotic cardiovascular disease.”
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