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Heart failure is a condition in which the heart’s ability to pump blood effectively to other parts of the body is reduced. The resulting symptoms include difficulty in breathing and shortness of breath, fatigue and weakness, and swelling in the legs, ankles, feet, or stomach. Heart failure may lead to congestive heart failure due to buildup of fluids in the lungs, liver, and lower extremities. About 50% of heart failure patients have reduced ejection fraction (HFrEF), that is, the amount of blood that leaves the ventricle to circulate the body after each contraction is reduced.
High blood pressure, coronary artery disease, heart valve disease, diabetes, and obesity are some of the major causative factors leading to heart failure. These factors, over a period of time, causes the heart to try and compensate for the added workload by developing thicker walls and getting larger and pumping more frequently, a condition known as “adverse modeling”. Heart failure treatment includes prescription drugs, reducing sodium intake, drinking less volume of liquids, and making necessary lifestyle changes like eating heart-friendly diet, maintaining moderate weight, and quitting smoking
Now, there is some wonderful news for heart failure patients. A study has found that a diabetes drug called empagliflozin significantly improved heart structure and function. What’s more, many of the study patients experienced a reversal of the debilitating disease! Empagliflozin is a sodium-glucose co-transporter 2 (SGLT2) inhibitor that is used to lower blood sugar levels in people with type 2 diabetes by causing the kidneys to get rid of more glucose in the urine. It is also used to reduce the risk of stroke, heart attack, or death in type 2 diabetes patients who also have heart and blood vessel disease.
Researchers from the Icahn School of Medicine at Mount Sinai in New York, who had set up a clinical trial called EMPATROPISM to investigate the use of empagliflozin for treating HFrEF in people without diabetes, presented the trial results on November 13, 2020, at the American Heart Association (AHA) Scientific Sessions 2020.
The double-blind, placebo-controlled, randomized study consisted of two groups from 84 participants between 18–85 years of age. Before the start of the trial, all participants underwent baseline evaluations that included cardiac MRI, a 6-minute walk test, and a cardiopulmonary exercise test to determine their oxygen levels, besides completing questionnaires regarding their quality of life. Members of one group were given 10 mg of empagliflozin daily, while the other group members received a placebo.
After six months, the participants completed the same tests as before the beginning of the trial. About 80% of those who received empagliflozin showed significant improvement in their condition, with a 16.6% improvement in left ventricle ejection fraction. Reduction in heart size and thickness, along with less congestion, was also observed, which indicated that their heart failure had become less severe. The researchers also noticed that the heart had returned to near normal in this group of participants. Most remarkable, indeed!
No severe side effects were seen, and the participants demonstrated improvements in their exercise levels and quality of life, which occurred quite quickly after beginning the medication. And, although empagliflozin is an antidiabetes drug, no adverse blood sugar-related side effects, such as hypoglycemia, were seen in the participants, despite them not having diabetes. In contrast, the participants who took a placebo showed no improvements, with their condition either staying the same or worsening, with a further reduced ejection fraction, increased size and thickness of the heart, and an abnormal change in its overall shape. According to the researchers, empagliflozin essentially reverses adverse modeling, that is, the heart trying to restructure itself to compensate for changes associated with chronic conditions.
The results concurred with an earlier trial—the EMPEROR-Reduced trial–a double-blind, placebo-controlled trial randomizing 3730 patients with Class II to IV heart failure and a reduced ejection fraction (HFrEF), with or without diabetes, who received empagliflozin 10 mg daily or placebo, in addition to recommended therapy. The results showed that participants (both with and without diabetes) taking empagliflozin experienced a lower risk of cardiovascular death or hospitalization for heart failure than those in the placebo group. The trial researchers commented that “it is conceivable that the use of SGLT2 inhibitors is set to become a new cornerstone in the treatment of patients with HFrEF.”
The EMPATROPISM study’s first author, Carlos Santos-Gallego, a postdoctoral fellow at the Icahn School of Medicine, commented, “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.”
References:
1. Medical News Today, November 21, 2020,
2. European Heart Journal, October 21, 2020,
3. MediLine Plus,
