A New Diabetes Drug That Can Treat and Reverse Heart Failure
Scientists have developed a drug that can effectively treat and reverse heart failure in diabetic and non-diabetic patients. The clinical trial also showed that the drug did not cause hypoglycemia, or low blood sugar, in non-diabetic patients.
Research findings from the Icahn School of Medicine at Mount Sinai published in the Journal of the American College of Cardiology showed that the new trial drug dubbed EMPATROPISM could improve the heart’s size, shape, and function, leading to better exercise capacity and quality of life, which will reduce hospitalizations for heart failure patients. The study’s first author Carlos Santos-Gallego, MD, postdoctoral fellow at the Icahn School of Medicine at Mount Sinai, said:
“Our clinical trial’s promising results show this diabetes drug can ameliorate the lives of heart failure patients with reduced ejection fraction, enhance their exercise capacity, and improve their quality of life with little to no side effects. We expect this work will help lead to U.S. Food and Drug Administration approval of empagliflozin for this patient population in the coming months.”
Failure Became Less Severe
The researchers recruited 84 patients suffering chronic heart failure with reduced ejection fraction (EF) and randomized their treatment with empagliflozin or a placebo. All the participants had baseline evaluations, including cardiac magnetic resonance imaging, a cardiopulmonary exercise test on a bicycle wearing a face mask to text oxygen levels, a six-minute walk test, and quality-of-life questionnaires.
The patients received treatment or placebo for six months, with some short safety visits at one and three months. At the six-month mark, patients went through the same tests. Results showed that at least 80 percent of the patients treated with empagliflozin showed significant improvement, and their hearts returned to near normal. The group had a 16.6 percent improvement in left ventricular ejection fraction at the six-month mark, and their hearts pumped blood more strongly. Their hearts also became smaller, less dilated because of less congestion and less fluid accumulation in the body, meaning that their heart failure became less severe. The heart walls were less thick, meaning that the left ventricle could pump blood more easily.
Improved Quality Of Life
The placebo group didn’t show any improvement, meaning they either stayed at baseline or their condition got worse. They had a diminishing EF, and their hearts became more dilated and thicker and had an abnormal, more spherical, shape. The study also showed that patients taking empagliflozin had roughly 10 percent improvement in their exercise levels, a statistically significant difference, while patients on the placebo arm showed no improvement. The result meant that the empagliflozin group became healthier, could do more everyday activities, and had an improved quality of life, putting them at less risk of hospitalization. Dr. Santos-Gallego said:
“Our study also identifies why this drug is effective: because it improves heart function, something that has not been understood until now […] many doctors are afraid of prescribing a drug they do not understand, and our findings will help clinicians feel more comfortable giving this to patients once approved. A cornerstone finding is that, although this drug was initially developed for diabetes, it is also incredibly effective in patients without diabetes.”
No Severe Side Effects
People with type-2 diabetes or heart failure independently are at a higher risk of getting the other. Both can also occur together and worsen a patient’s health, care costs, and life quality. The risk factors behind type-2 diabetes and heart failure are similar, yet there’s little guidance on caring for people with both conditions. Recent studies have found new treatments for diabetes may also improve heart failure outcomes, showing the interplay between the two conditions. Juan Badimon, Ph.D., Professor of Medicine (Cardiology) and Director of the Atherothrombosis Research Unit at the Cardiovascular Institute at the Icahn School of Medicine at Mount Sinai, and a co-author of the study conclude:
“We were very surprised at how fast the benefits appeared with empagliflozin. The patients were already feeling better in the first few weeks of taking it. Another key issue is how safe this drug is; we saw no severe side effects, despite being an anti-diabetic drug, no hypoglycemia was noticed. This shows that empagliflozin is a safe and potent treatment for heart failure with reduced ejection fraction independently of the diabetic status of the patient.”