Skip to main content
Home
Browse topics
Cardiovascular disorders Chronic kidney disease Diabetes devices & technology GLP-1 receptor agonists Hyperglycemia Hypoglycemia Obesity, diet, & lifestyle interventions SGLT2 inhibitors Type 1 diabetes Type 2 diabetes Browse all topics
EN
EN
In focus
Novel clinical evidence in continuous glucose monitoring Fasting for religion and health in people with diabetes The challenge of type 2 diabetes in children HFpEF & diabetes: Diagnosis and management in the wake of EMPEROR-Preserved Addressing suicide risk in diabetes: Rates and risk factors, HCP fears, and practical advice The SURPASS trials: Summarizing efficacy data on tirzepatide Semaglutide for weight loss: STEP and SELECT trials: Results from the STEP and SELECT trials Why psychosocial care matters DiRECT: Type 2 diabetes remission through weight management
Congress coverage
EASD 58th Annual Meeting 2022 The American Diabetes Association 82nd Scientific Sessions
About us
Medicine Matters Diabetes
EXTENDED SEARCH

Medicine Matters diabetes

We've had two large-scale trials of SGLT2 inhibitors in patients with heart failure and a reduced ejection fraction with and without diabetes. The first trial was DAPA-HF, was with dapagliflozin, was presented about a year ago. And just recently, we completed and presented the results of EMPEROR-Reduced trial, which was with empagliflozin. The two types of patients, the patients in the two trials, were very similar, except that the DAPA-HF trial focused more on the milder end of heart failure and the reduced ejection fraction, whereas we focused more on the severe end. Our patients had lower ejection fractions, higher levels of natriuretic peptide, worse renal function, and they had a greater use of background therapy with neprilysin inhibitors.



We had very similar primary endpoint, but the EMPEROR-Reduced trial was unusual in that we not only highlighted the effects of the drug on heart failure, but we highlighted the effects of the drug on the kidney. And we pre-specified three major outcomes, only three major outcomes. A primary outcome was cardiovascular death or hospitalization for heart failure. We showed a 25% reduction in the risk of that endpoint, highly statistically significant.



Second endpoint was total hospitalizations for heart failure. Empagliflozin reduced that outcome by 30%, highly statistically significant. And the third outcome was a renal outcome focused on the kidneys, and we looked at the slope of change in glomerular filtration rate over time. Markedly slowed with empagliflozin, highly statistically significant.



But what was really impressive is we found a 50% reduction in the risk of serious renal events, chronic dialysis, transplant, renal death, profound sustained reductions in glomerular filtration rate. So EMPEROR-Reduced achieved all three of the major outcome variables that it had planned to examine and achieved them, in all cases, of a magnitude that was clinically important and highly statistically significant. Now, if you compare the effects of DAPA-HF and EMPEROR-Reduced, they're amazingly concordant. So consistent between the two studies.



There was a almost identical reduction in the risk of cardiovascular death and hospitalization for heart failure by 25%. 30% reduction in hospitalizations for heart failure. We found somewhat greater effects on our renal endpoint and DAPA-HF somewhat greater effects on cardiovascular death, but these are really largely related to the number of events. The findings of these two trials on all variables are so concordant, not only between the two trials, but also with the trials done with these two same drugs in large-scale trials of patients with type 2 diabetes.



Well, if you put the two trials together, we are covering a very broad range of real-world patients with heart failure. Most patients in the real world with heart failure have class II symptoms, and between the patients studied in DAPA-HF and the patients studied in EMPEROR-Reduced, we studied a broad range of ejection fractions and natriuretic peptides amongst the patients with heart failure and a reduced ejection fraction. But here's what's really important. In both trials, patients were already receiving all recommended treatment for heart failure and the reduced ejection fraction. So SGLT2 inhibitors improved outcomes on top of what is considered now to be standard of care therapy for heart failure and a reduced ejection fraction.



Well, we have a level of consistency, concordant evidence, which is really unusual in medicine. And when you see this level of consistency, when you see this kind of evidence reinforcing, you have a high degree of confidence this represents not only a real finding but an important one. So we are really expecting that the clinical community and various organizations all over the world in a broad range of disciplines will now embrace the use of dapagliflozin and empagliflozin as a standard of care in patients with heart failure and a reduced ejection fraction with or without diabetes to be added to all currently recommended treatments.