FDA Approves Heart Benefits for Wegovy Weight Loss Drug

Obesity is a world-wide problem. It’s no wonder, then, that injectable drugs like semaglutide (Ozempic, Wegovy) and tirzepatide (Mounjaro, Zepbound) have become incredibly popular. Wegovy just got another big boost from the FDA. That’s because the agency has decided to allow Novo Nordisk to promote the heart benefits for Wegovy. How good is semaglutide at reducing the risk for heart attacks and strokes?

Why Did the FDA Approve Heart Benefits for Wegovy and NOT Ozempic?

Ozempic:

There are three forms of semaglutide. First came Ozempic. The FDA approved this self- injectable form of semaglutide in 2017 for the treatment of type 2 diabetes.

Rybelsus:

An oral version of semaglutide received the green light from the FDA in 2019. This formulation was also approved exclusively for type 2 diabetes.

Wegovy (pronounced wee-GOH-vee):

The same medication (semaglutide) received the FDA’s blessing for overweight people in 2021.

Here is the language in the official prescribing information:

“WEGOVY is indicated as an adjunct to a reduced calorie diet and increased physical activity for chronic weight management in:
“• adults with an initial body mass index (BMI) of:
• 30 kg/m2 or greater (obesity) or
• 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition (e.g., hypertension, type 2 diabetes mellitus, or dyslipidemia)
• pediatric patients aged 12 years and older with an initial BMI at the 95th percentile or greater standardized for age and sex (obesity).”

So, now you know that there are 3 different brand names of semaglutide. Only Wegovy has FDA approval for weight loss, though we strongly suspect that all three brands would accomplish a similar result.

The Heart Benefits for Wegovy:

Research published in the New England Journal of Medicine (Dec. 14, 2023) demonstrated that:

“In this randomized, placebo-controlled trial involving patients with preexisting cardiovascular disease and overweight or obesity but without diabetes, weekly subcutaneous semaglutide at a dose of 2.4 mg was superior to placebo in reducing the incidence of a composite of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke at a mean follow-up of 39.8 months.”

The FDA’s statement in support of the heart benefits of Wegovy:

“Wegovy is now the first weight loss medication to also be approved to help prevent life-threatening cardiovascular events in adults with cardiovascular disease and either obesity or overweight,” said John Sharretts, M.D., director of the Division of Diabetes, Lipid Disorders, and Obesity in the FDA’s Center for Drug Evaluation and Research. “This patient population has a higher risk of cardiovascular death, heart attack and stroke. Providing a treatment option that is proven to lower this cardiovascular risk is a major advance for public health.”

How Good Are the Heart Benefits of Wegovy?

The manufacturer, Novo Nordisk, completed a placebo-controlled trial with more than 17,000 overweight patients. The participants had cardiovascular disease but not diabetes.

Over the nearly three years of this study, people taking Wegovy were 20 percent less likely to have heart attacks or strokes or to die from cardiovascular complications compared to those taking placebo. The absolute difference between the two groups was 1.5%, which yields a number needed to treat of 67.

In other words, 67 people needed to take semaglutide to protect one person from heart attack, stroke or cardiovascular death. It is not clear whether the benefits are due primarily to weight loss associated with Wegovy or whether the drug has additional effects that reduce the chance of cardiovascular problems.

The authors of the study in the New England Journal of Medicine seem to suggest that the drug itself may have cardiovascular benefits:

“Medications in the GLP-1 receptor agonist class have been shown in animals with or without diabetes to reduce inflammation, improve endothelial and left ventricular function, promote plaque stability, and decrease platelet aggregation. In this trial, semaglutide was associated with changes in multiple biomarkers of cardiovascular risk, including blood pressure, waist circumference, glycemic control, nephropathy, and levels of lipids and C-reactive protein… Although our understanding of the mechanisms of cardiovascular protection with semaglutide remains speculative, the consistent effects on cardiometabolic risk factors support the hypothesis that clinical benefit is achieved through multiple interrelated pathways.”

What About Side Effects?

Quite a few of the volunteers in this study experienced side effects that led them to withdraw from the study. The dropout rate was 16% for those in the Wegovy group compared to 8% for those on placebo. The most common adverse reactions associated with Wegovy include nausea, diarrhea, vomiting, constipation, stomachache, headache, fatigue, flatulence and heartburn.

The FDA’s announcement about the heart benefits of Wegovy lists a lot of potential adverse reactions:

“The prescribing information for Wegovy contains a boxed warning to inform health care professionals and patients about the risk of thyroid C-cell tumors. Because of this risk, Wegovy should not be used in patients with a personal or family history of medullary thyroid carcinoma or in patients with a rare condition called Multiple Endocrine Neoplasia syndrome type 2.

“Wegovy should not be used in patients with a history of a severe allergic reaction to semaglutide or to any of the other ingredients. Patients should stop Wegovy immediately and seek medical help if a severe allergic reaction is suspected.

We are always astonished by such a caution. How could anyone know in advance of taking a drug such as semaglutide if they would be allergic to it? To be fair, the FDA does suggest that if you have a “history of a severe allergic reaction…” you should avoid the drug. But you will never know that until you take it.

More FDA cautions about Wegovy:

“Wegovy also contains warnings for inflammation of the pancreas (pancreatitis), gallbladder problems (including gallstones), low blood sugar, acute kidney injury, hypersensitivity reactions, diabetic retinopathy (damage to the eye’s retina), increased heart rate and suicidal behavior or thinking. Patients should discuss with their health care provider if they have symptoms of pancreatitis or gallstones. If Wegovy is used with insulin or with a medication that causes insulin secretion, patients should speak to their health care provider about the risk of low blood sugar. Healthcare professionals should monitor patients for kidney disease, diabetic retinopathy and depression or suicidal behaviors or thoughts.

“The most common side effects of Wegovy include 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).”

Final Words About the Heart Benefits for Wegovy:

You can read how visitors to this website have reacted to semaglutide at this link.

Please share your own experience with this drug in the comment section below.