John B. Buse, MD, PhD: The EMPA-REG trial was a trial of empagliflozin versus placebo. It studied 2 different doses of empagliflozin, 10 mg and 25 mg once a day, versus matched placebo, and went on for approximately 3 years. In the trial, the primary endpoint was the first occurrence of a heart attack, a stroke, or cardiovascular death. And very importantly, those outcomes were blindly adjudicated, so the people who were deciding whether the event actually happened or not weren’t aware of what drug or dose they were assigned to.

In the EMPA-REG trial, there was a 14% reduction in the primary endpoint, the first occurrence of heart attack, stroke, or cardiovascular death; a 38% reduction in cardiovascular death; a 35% reduction in heart failure or hospitalization; and a meaningful reduction in either the advancement or progression of a chronic kidney disease. So, it was pretty much a slam-dunk win for empagliflozin in that trial.

And to me, one of the most impressive things about the results is that the benefits were pretty similar between the 2 doses: 10 mg and 25 mg. So, it’s almost as if there were 2 trials done because we had benefits at both doses for most of those endpoints. From a safety perspective, their performance was pretty stellar as well. We know that these drugs are associated with an increased risk of vaginal yeast infections in women, and balanitis, or basically yeast infection of the foreskin, in men. But otherwise, there was very little evidence of any adverse events with the drug, specifically minimal imbalances in urinary tract infections, bone fractures, and other outcomes that are mentioned in the package insert of the drug.

Impact of EMPA-REG OUTCOME

John B. Buse, MD, PhD, discusses the efficacy and safety findings from the EMPA-REG OUTCOME trial with empagliflozin in patients with type 2 diabetes mellitus.
Published Online: August 10, 2017


John B. Buse, MD, PhD: The EMPA-REG trial was a trial of empagliflozin versus placebo. It studied 2 different doses of empagliflozin, 10 mg and 25 mg once a day, versus matched placebo, and went on for approximately 3 years. In the trial, the primary endpoint was the first occurrence of a heart attack, a stroke, or cardiovascular death. And very importantly, those outcomes were blindly adjudicated, so the people who were deciding whether the event actually happened or not weren’t aware of what drug or dose they were assigned to.

In the EMPA-REG trial, there was a 14% reduction in the primary endpoint, the first occurrence of heart attack, stroke, or cardiovascular death; a 38% reduction in cardiovascular death; a 35% reduction in heart failure or hospitalization; and a meaningful reduction in either the advancement or progression of a chronic kidney disease. So, it was pretty much a slam-dunk win for empagliflozin in that trial.

And to me, one of the most impressive things about the results is that the benefits were pretty similar between the 2 doses: 10 mg and 25 mg. So, it’s almost as if there were 2 trials done because we had benefits at both doses for most of those endpoints. From a safety perspective, their performance was pretty stellar as well. We know that these drugs are associated with an increased risk of vaginal yeast infections in women, and balanitis, or basically yeast infection of the foreskin, in men. But otherwise, there was very little evidence of any adverse events with the drug, specifically minimal imbalances in urinary tract infections, bone fractures, and other outcomes that are mentioned in the package insert of the drug.
View More From This Discussion
Episode 1 Impact of the EMPA-REG Study in Type 2 Diabetes
Episode 2 Cardiovascular Outcomes With GLP-1 Receptor Agonists in Type 2 Diabetes
Episode 3 SGLT2 Inhibition and CVD Outcomes in Type 2 Diabetes
Episode 4 Cardiovascular Outcomes Trials With Anti-Diabetes Medications
Episode 5 Understanding Heart Failure in Diabetes
Episode 6 Big Data and CVD Benefits of Anti-Diabetes Medications
Episode 7 Designing Better Cardiovascular Outcomes Trials in Diabetes
Episode 8 Big Data Analysis and Clinical Decision Making in Diabetes
Episode 9 Cost-Effectiveness and Coverage Decisions in Diabetes
Episode 10 Shared Decision-Making in Diabetes
Episode 11 A Historic View on CV Outcomes in Diabetes
Episode 12 Impact of EMPA-REG OUTCOME
Episode 13 Results From the CANVAS Trial
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