Heart failure affects around 60 million people worldwide. For the first time, an existing drug has been shown to be effective in treating patients with heart failure with reduced ejection fraction, the most common form of heart failure in the elderly. Phase II of a large clinical trial at Charité – Universitätsmedizin Berlin confirms the benefits of empagliflozin, an SGLT2 antidiabetic drug: the treatment reduces the risk of hospitalization or cardiovascular death by 21%. The study was published in the New England Journal of Medicine (NEJM) and represents a major advance in the field of cardiology.
Heart failure with reduced ejection fraction
Heart failure is the inability of the heart to pump enough blood to supply the whole body. This means that organs such as muscles, nerves, and the brain are no longer optimally supplied with oxygen and nutrients. In many cases, this initially manifests itself as temporary fatigue from exertion and difficulty breathing. As the disease progresses, patients experience shortness of breath with little exertion or even at rest. Another common symptom is fluid retention. Heart failure not only affects the quality of life but can also lead to death: A patient with untreated heart failure has a 50% increased risk of dying within 5 years.
Treatment options for heart failure with a reduced ejection fraction, the most common form of heart failure in the elderly, are extremely limited. The lead author of the study, Dr. Stefan Anker from the Clinic for Internal Medicine and Cardiology at the Charité explains that so far, treatment has focused on treating comorbidities (including high blood pressure and diabetes) and symptoms. A number of clinical trials have investigated different treatments, but the results have never been statistically significant.
Repurposing Empagliflozin an antidiabetic medication
Empagliflozin appears to be the first drug to show statistically significant and clinically important benefits. This oral anti-diabetic agent, which belongs to a class of sodium-glucose co-transporter 2 (SGLT2) inhibitors, lowers blood glucose levels by inhibiting SGLT2, helps to excrete salt from the body, and removes excess water from the blood. Already in 2020, the EMPEROR-Reduced clinical trial suggested its efficacy in patients with heart failure and reduced ejection fraction. Thus, empagliflozin is currently approved in Europe for the treatment of type 2 diabetes and heart failure with reduced ejection fraction (with or without diabetes).
The phase II clinical trial of EMPEROR-Preserved confirmed the efficacy of the drug in patients with heart failure. The study involved nearly 6000 patients with mild to moderate heart failure (varying diabetic status), with an average age of 72 years, from 23 countries. About half of the participants have been receiving one empagliflozin tablet a day for just over 2 years. The trial found that :
- 17.1% of participants in the control group were hospitalized or died during the follow-up period.
- In the empagliflozin group, the rate was 13.8%, meaning that the risk of hospitalization or death was reduced.
- The participants receiving the drug also reported fewer symptoms.
- The treatment with empagliflozin was associated with a slight increase in the frequency of some side effects, but these were mild and easily treatable according to the lead author of the study.
“For the first time, we have a treatment for heart failure with reduced ejection fraction that offers patients a drug that improves both their prognosis and their well-being and has a very good safety profile.” says one of the authors.
Currently, patients suffering from heart failure have very limited choices for treating and relieving the symptoms of this dangerous condition. Adding the anti-diabetic drug Empagliflozin to the arsenal that doctors have to treat this condition would surely help save lives.