Pros and Cons of Wegovy's New Heart Health Approval
Verywell / Julie Bang
Fact checked by Nick Blackmer
Key Takeaways
The FDA has approved Wegovy to reduce the risk of heart attack, stroke, and other cardiovascular problems in adults with heart disease who are overweight or who have obesity.
Wegovy was previously approved for weight management.
Experts say this approval expands treatment options for those living with obesity and heart disease and could widen insurance coverage for the costly drug.
The Food and Drug Administration (FDA) approved Novo Nordisk’s popular weight loss drug Wegovy for a new indication, extending its use to the prevention of heart attacks, stroke, and other cardiovascular problems in adults with heart disease and who have overweight or obesity.
The approval was based on a study that demonstrated Wegovy significantly lowered the risk of major adverse cardiovascular events. The study showed individuals with heart disease and who were diagnosed with overweight or obesity were 20% less likely to experience such issues compared to patients who took a placebo.
Related: Wegovy Can Reduce the Risk of Stroke and Heart Attack by 20% in People With Obesity
“This patient population has a higher risk of cardiovascular death, heart attack, and stroke,” John Sharretts, MD, director of the Division of Diabetes, Lipid Disorders, and Obesity in the FDA’s Center for Drug Evaluation and Research, said in a press release. “Providing a treatment option that is proven to lower this cardiovascular risk is a major advance for public health.”
The injectable treatment is already FDA-approved for chronic weight management in adults with a body mass index (BMI) of 27 kg/m2 or greater with at least one weight-related condition, like high blood pressure, type 2 diabetes, or high cholesterol, as well as adults with a BMI of 30 kg/m2 or greater. Children aged 12 and up living with obesity may also be eligible for the drug.
Related: What's the Difference Between Ozempic, Wegovy, and Mounjaro?
How Are Obesity and Overweight Defined?
Organizations like the Centers for Disease Control and Prevention recognize BMI as a flawed metric; it’s not a good indicator of your health or your fat. Still, it’s used as the primary way to diagnose obesity and overweight. The metric is calculated based on a person’s weight in kilograms and height in square meters.
Underweight: Less than 18.5 kg/m2
Healthy weight: 18.5 to <25 kg/m2
Overweight: 25 to <30 kg/m2
Obese: 30 kg/m2 or higher
A Lifesaving Approval
A major benefit of the approval is that it expands the number of patients who can access to Wegovy, Mir Ali, MD, bariatric surgeon and medical director of MemorialCare Surgical Weight Loss Center at Orange Coast Medical Center in Fountain Valley, CA, told Verywell.
“The main pro is that if a patient had not [previously] met the criteria because of their weight alone, but they’re considered overweight and they have heart disease, they can now have this medication prescribed,” Ali said.
He added that Wegovy’s approval has the potential to prolong lives by addressing two of the leading causes of preventable deaths—obesity and heart disease—in tandem.
This approval also gives healthcare providers another tool to help combat the rising epidemic of heart disease in the United States, Michael Chan, MD, an interventional cardiologist with Providence St. Joseph Hospital in Orange County, CA, told Verywell in an email.
Chan added that FDA approval may widen insurance coverage for the costly drug.
“Most insurance companies, including Medicare, do not currently cover weight loss drugs,” Chan said. “This expanded FDA indication could possibly lead to some insurers expanding coverage to those patients with high cardiovascular risk.”
How Much Does Wegovy Cost?
The cost of Wegovy can vary based on insurance coverage, dosage, location, and pharmacy. Right now, the medication costs roughly $1,200 to $1,500 per month out of pocket, Ali said. If it is covered by insurance, co-pays can be as high as $250 per month or more.
Access May Not Be Easy
Since FDA approval makes Wegovy accessible to more patients, it could lead to further shortages of the medication, especially given the drug’s previous shortages caused by rising demand, Ali said.
“There’s already a shortage of this medication and I don’t think manufacturers are necessarily increasing production,” Ali said. “Because of its broader indication, there’s going to be more demand. Therefore, there may be even more of a shortage of this medication.”
Another potential downside of FDA approval is that the list price of the medication may remain high or even increase, Ali said. Since the process of developing and obtaining FDA approval involves significant research and developmental costs, pharmaceutical companies may adjust the price of the drug to recoup these expenses.
“It’s a long, expensive process to get FDA approval—drug companies want to get that money back,” said Ali. “Perhaps this leads to a higher copay or some other problem [for the patient] in getting the medication.”
Potential Wegovy Side Effects
Wegovy can cause some side effects, including nausea, diarrhea, vomiting, constipation, abdominal (stomach) pain, headache, fatigue, dyspepsia (indigestion), dizziness, abdominal distension, eructation (belching), hypoglycemia (low blood sugar) in patients with diabetes, flatulence (gas buildup) and gastroesophageal reflux disease (heartburn).
How Does Wegovy Work to Reduce the Risk of Cardiovascular Disease?
Wegovy works by mimicking a naturally-occurring hormone in the body called GLP-1, Cheng-Han Chen, MD, a board-certified interventional cardiologist and medical director of the Structural Heart Program at MemorialCare Saddleback Medical Center in Laguna Hills, CA, told Verywell.
GLP-1 is a hormone that sends signals to the brain to induce feelings of fullness, leading to a reduction in food intake. It also slows down the rate at which the stomach empties its contents into the small intestine, making you feel full for a longer amount of time.
That satiety can help you lose weight, which is an important part of managing conditions like diabetes, high blood pressure, and chronic inflammation. This, in turn, can have a positive influence on cardiovascular health—though other heart-healthy mechanisms may be at play too.
“If you can reduce risk factors like excess weight, high blood sugar, and high blood pressure, you can reduce your risk of heart disease,” Chen said. “Over time, this also decreases the risk of endpoints such as heart attack or stroke.”
What This Means For You
If you think you’re a good candidate for Wegovy, you’ll need an evaluation and prescription from your healthcare provider. Reach out to your provider to confirm whether Wegovy is appropriate for your specific situation and health needs.
Read the original article on Verywell Health.
