A study published in the Journal of the American College of Cardiology suggests a newly-developed diabetes medication called Empagliflozin effectively treats and reverses heart failure in both diabetic and non-diabetic patients. The research, conducted at the Icahn School of Medicine at Mount Sinai in New York City, was a clinical trial that showed that the medication can improve the heart’s size, shape, and function, leading to better exercise capacity and quality of life.
The conclusion of this study suggests that these outcomes will reduce hospitalizations for heart failure patients.
ScienceDaily quotes lead author, Carlos Santos-Gallego, MD, who is a postdoctoral fellow at Icahn: “Our clinical trial’s promising results show this diabetes drug can ameliorate 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 (FDA) approval of empagliflozin for this patient population in the coming months.”
Gallego adds that the study also explained the mechanisms of the drug, whereas, with other medications, many doctors may be afraid of prescribing a drug if they do not understand how it works. “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,” says Gallego on ScienceDirect.com.
Another bonus of the new drug is that it appears not to cause low blood sugar (hypoglycemia) in patients that don’t have diabetes.
For the trial, researchers recruited 84 patients with chronic heart failure with reduced ejection fraction (EF). This is the percentage of blood the left ventricle pumps with each contraction.
The subjects were randomized either into the Empagliflozin treatment group or a placebo.
Evaluations were determined based on cardiac magnetic resonance imaging; an exercise bicycle stress test; which measured oxygen levels; a six-minute walk test; as well as quality-of-life questionnaires.
The trial lasted six months, at which point the patients were retested. Approximately 80 percent of the patients treated with empagliflozin showed significant improvement, and their hearts returned to near normal, the researchers found.
At the conclusion of the study, the treatment group experienced an over 16% improvement in left vent ventricular ejection fraction. Also, the researchers report that the treatment group also possessed stronger pumping of blood from the heart.
The MRIs revealed at the conclusion of the study that the treatment group also had less dilation. This is because of less congestion and less fluid accumulation in the body. Other observations included less thickening in the cardiac walls, which allows for blood to pump more easily through the left ventricle.
In comparison to the treatment group, the participants given placebo experienced either no improvement or a worsening of their heart failure.
Moreover, the patients who took empagliflozin, witnessed an approximately 10 percent improvement in their exercise levels.
“This demonstrated that the empagliflozin group became healthier, could do more everyday activities, and had an improved quality of life, putting those patients at less risk of hospitalization,” ScienceDaily summarizes.
More than just reporting on the drug’s promising outcomes, the study also explains how it works. “Adverse remodeling” in heart failure describes how, when the left ventricle dilates, it becomes thicker. This leads to weaker pumping and a lower ejection fraction. Empagliflozin seems to both lessen and reverse adverse remodeling by reducing the dilation and hypertrophy of the left ventricle. This, in turn, helps the left ventricle pump more strongly (increasing the ejection fraction). The drug’s actions also change the shape of this region of the heart, making it become more elongated and less spherical.
Co-author of the study, Juan Badimon, PhD, Professor of Medicine (Cardiology) and Director of the Atherothrombosis Research Unit at the Cardiovascular Institute at Icahn says via ScienceDaily:
“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 antidiabetic drug, no hypoglycemia was noticed. This shows that empagliflozin is a safe and potent treatment for heart failure….”