FDA approves weight loss drug Wegovy to lower heart disease risk

By Staff 9 Min Read

  • On March 8, the FDA approved the use of Wegovy to reduce the risk of cardiovascular death, heart attack, and stroke in adults with heart disease with obesity or overweight.
  • In 2021, the FDA approved the semaglutide-containing medication for chronic weight management in adults with obesity or overweight with at least one weight-related condition.
  • Semaglutide was originally approved by the FDA in 2017 to treat type 2 diabetes in adults.

On March 8, the FDA approved the semaglutide medication Wegovy to help reduce the risk of cardiovascular death, heart attack, and stroke in adults with heart disease who have obesity or overweight.

The indication recommends using semaglutide in addition to a reduced-calorie diet and increased physical activity.

Semaglutide was originally approved by the Food & Drug Administration (FDA) in 2017 to treat type 2 diabetes in adults.

In 2021, the FDA approved the semaglutide medication Wegovy developed by Novo Nordisk for weight management in adults with obesity or overweight with at least one weight-related condition.

Semaglutide medications belong to a class of drugs known as glucagon-like peptide-1 (GLP-1) receptor agonists that were originally developed to treat type 2 diabetes. GLP-1 drugs have since exploded in popularity as a weight loss treatment.

In recent years, researchers have examined how semaglutide affects cardiovascular health. A 2021 study, for instance, found a connection between semaglutide and anti-atherosclerotic effects.

A 2023 study reported semaglutide may improve cardiometabolic risk factors and reduce the use of high blood pressure and high cholesterol medications in adults with obesity who did not have diabetes.

Dr. Cheng-Han Chen, a board certified interventional cardiologist and medical director of the Structural Heart Program at MemorialCare Saddleback Medical Center in Laguna Hills, CA, explained to Medical News Today how a diabetes and weight loss drug could help with cardiovascular health.

Dr. Chen said that by aiding weight loss and weight control, this class of drugs, in turn, may affect risk factors for cardiovascular disease, such as high blood pressure and high cholesterol.

“By treating one aspect of this metabolic syndrome, this will in turn improve the other risk factors for heart disease, which then downstream improves the cardiovascular outcomes. The short answer is that everything is connected and a lot of the reasons people are getting heart disease all stem back to glucose control (and) weight control.”

— Dr. Cheng-Han Chen, cardiologist

The FDA’s new approval is based on the results of the SELECT cardiovascular outcomes clinical trial.

The study was able to show that Wegovy “statistically significantly reduced” the risk of major adverse cardiovascular events — including cardiovascular death, non-fatal heart attack, or non-fatal stroke — by 20% in adults who are either overweight or obese and with an established cardiovascular disease.

Additionally, the trial found the use of semaglutide also reduced a person’s cardiovascular death risk by 15% and death from any cause by 19%, compared to those who took a placebo.

“We know that obesity, in and of itself, increases cardiovascular risk. And by losing weight, patients can reduce that risk,” Dr. Mir Ali, a bariatric surgeon and medical director of MemorialCare Surgical Weight Loss Center at Orange Coast Medical Center in Fountain Valley, CA, told MNT.

“What was interesting about this study is that there seems to be more to the effect of these weight loss medications than just helping the patient lose weight. And unfortunately, they couldn’t address that in this study, but more research needs to be seen in that area.”

— Dr. Mir Ali, bariatric surgeon

Experts agree the FDA’s new indication for semaglutide is needed.

“Cardiovascular disease remains the number one killer of people in the world, despite everything we’ve done in the last few decades, so it’s very important that we continue to find more ways to reduce people’s morbidity and mortality from this disease,” Dr. Chen noted.

“Many cardiovascular conditions, including heart failure and advanced vascular disease, result in a risk of death that exceeds the risk seen in many cancers,” Dr. Matthew Saybolt, medical director of the Structural Heart Disease Program at Hackensack Meridian Jersey Shore University Medical Centers told MNT.

“Cardiovascular disease, particularly when associated with obesity, is a public health emergency, and any safe treatment that decreases the chance of death or complications will be in high demand. We have so much still to solve in the treatments of these conditions,” Dr. Saybolt added.

Dr. Angela Fitch, president of the Obesity Medicine Association and chief medical officer of knownwell, said the FDA approval for Wegovy is exciting news for people with heart disease and clinicians who treat them.

“This approval is an integral step in the right direction towards getting patients access to potentially life-saving medication,” Dr. Fitch said.

Semaglutide medications work by impersonating the GLP-1 hormone in the body that is naturally released by the gastrointestinal system when eating. This hormone tells the body to produce more insulin, reducing blood sugar levels.

“Semaglutide is a medication taken via a self-administered injection, prescribed by a doctor, which increases the amount of insulin that is produced by the pancreas, while also decreasing the amount of glucagon produced from the liver,” Dr. Fitch explained.

“These medications work in the brain, in the hypothalamus, to directly reduce appetite and cravings.”

There are several medications currently on the market that use semaglutide as their main ingredient, including:

Presently, Wegovy is the only semaglutide medication FDA-approved for both weight loss and cardiovascular risk reduction.

Ozempic and Rybelsus are currently only approved for the treatment of type 2 diabetes. However, some people use these medications off-label for weight loss.

Doctors also agree that as research continues, we may continue to see more and more uses for semaglutide as time goes on.

For example, a recent study found that semaglutide under the brand name Ozempic may help reduce kidney disease progression.

Other studies are currently evaluating the use of semaglutide in treating conditions such as:

“I think so because it’s a hormone and hormones have a wide range of effects throughout the body,” Dr. Ali commented. “As people focus on different areas, we may see more research on different effects.”

Dr. Saybolt noted anything that positively impacts a person’s weight, such as inflammation, blood sugar, blood pressure, and cholesterol, “could have a positive impact on just about any organ in the human body.”

“This stamp of approval from the FDA continues to support what the medical community has known all along — GLP-1s are here to treat serious chronic diseases, now cardiovascular disease in addition to diabetes and obesity. The research backing its use for other diseases, such as kidney disease (and) mental health addiction, to name a few, is extremely promising, I definitely foresee the FDA to continue to approve GLP-1s for use to combat other issues.”

— Dr. Angela Fitch, president of the Obesity Medicine Association

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