First Weight-Loss Drug Approved to Reduce Cardiovascular Risks – What You Need to Know

Demand is still surging for “weight-loss” medications sold under different brand names that contain the drug semaglutide in the form of injections. Now, one of those medications, Wegovy, has become the first to be approved by the U.S. Food and Drug Administration (FDA) to reduce the risk of cardiovascular death, heart attack and stroke in adults with cardiovascular disease who are either obese or overweight.

Semaglutide falls under a class of medications known as “glucagon-like peptide 1” (GLP-1) – and it is part of therapy already established for the management of type 2 diabetes, also resulting in some weight reduction and favorable management of heart disease. Other weight-loss drugs, such as Ozempic, Mounjaro and Zepbound, have not been approved to reduce serious cardiovascular risks.

Additionally, Medicare will now allow coverage of Wegovy for enrollees in Part D plans following the FDA-approval. The Medicare coverage applies when prescribed to prevent heart attacks and strokes in patients, states a new policy issued in March by the U.S. Centers for Medicare and Medicaid Services.

Jonathan Fialkow, M.D., Chief Population Health Officer for Baptist Health and chief of cardiology at Baptist Health Miami Cardiac & Vascular Institute.

“The Medicare expansion should make this drug available to a large segment of patients who will benefit from these therapies and may have been unable to afford them otherwise,” explains cardiologist Jonathan Fialkow, M.D., chief medical executive of Population Health, Value and Primary Care for Baptist Health, and deputy director of Clinical Cardiology at Baptist Health Miami Cardiac & Vascular Institute.

Being obese or overweight, affecting about 70 percent of U.S. adults, can be a serious health issue that increases the risk for premature death and a variety of health problems, including heart attack and stroke.

“Wegovy is the first obesity drug with an indication to decrease cardiac events,” said Dr. Fialkow. “Ozempic and Mounjaro are indicated for diabetics with obesity. Wegovy and Zepbound are indicated for obese patients with additional weight-related medical condition. They are all forms of semaglutide. The new indication for cardiac event reduction in obese patients with cardiovascular disease is only for Wegovy at present.”

Popularity of Weight-Loss Drugs Fuels Shortages

The popularity of all weight-loss drugs among non-diabetics or those without underlying health issues is concerning for the medical community. Such “off-label” widespread use has caused shortages of the drugs for those who need them the most. Everyone considering their use for weight loss should consult with their doctor. Additionally, new research has found that GLP-1 agonists have been associated with higher risk of serious side effects including pancreatitis, or inflammation of the pancreas, which can cause severe abdominal distress.

“Availability remains limited, including in patients who meet FDA-approved indications,” said Dr. Fialkow. “This is due to payor coverage determinations and supply issues. This indication should expand the patients who are eligible, increase the number of doctors who will gain experience and comfort in prescribing it -- and could further strain our supply issues. We hope the indication will allow liberalization of approvals for patients who are appropriately prescribed the medication.” 

Patients Also Require Proper Lifestyle Adjustments

Patients who are prescribed Wegovy are given specific advice on establishing reduced-calorie diets and increased physical activity.

“In our established and protocol-driven weight management programs, we make sure the patients receive proper assessment and education, and they are followed to be sure they perform the proper lifestyle adjustments proven to maintain healthy weight loss,” explains Dr. Fialkow. “This does not appear to be as robust in the community. Many are given the medications  -- some are not even the prescribed form manufactured for maximum efficacy and safety -- and then left to their own to manage.”

Wegovy’s efficacy and safety for reducing serious cardiovascular risks were researched in a “multi-national, multi-center, placebo-controlled” trial that “randomly assigned over 17,600 participants to receive either Wegovy or placebo,” states the FDA. Participants in both groups also received standard-of-care medical treatment, such as management of blood pressure and cholesterol, and healthy lifestyle counseling including diet and physical activity.

Wegovy significantly reduced the risk of major adverse cardiovascular events (cardiovascular death, heart attack and stroke), the FDA states.

 The study’s authors conclude: “In patients with preexisting cardiovascular disease and overweight or obesity but without diabetes, weekly subcutaneous (just under the skin) semaglutide at a dose of 2.4 mg was superior to placebo in reducing the incidence of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke at a mean follow-up of 39.8 months.”