The blockbuster new weight loss drugs, Wegovy and Ozempic, could become even more popular now that researchers have found that injections of semaglutide — the drug in Wegovy and Ozempic — sharply cut heart attacks, strokes and cardiac deaths in addition to helping people lose a significant percentage of weight.
New information related to the weight loss drugs is emerging as research continues, and patients who want to shed pounds clamor to try Wegovy, Ozempic and a competing drug called Mounjaro.
UCHealth expert, Dr. Cecilia Low Wang, predicts that the study results related to the cardiovascular effects of semaglutide — the generic name for the drug used in Wegovy and Ozempic — could have far-reaching impacts.
That’s because researchers found that the risk of adverse cardiovascular events dropped by about 20% for study volunteers who took Wegovy compared to those who received a placebo injection.
“The cardiovascular benefits are really significant,” said Low Wang, an expert on endocrinology, diabetes and metabolism and a professor at the University of Colorado School of Medicine on the Anschutz Medical Campus.
“Cardiovascular disease is a leading cause of death in the U.S., and if we can prevent adverse cardiovascular events such as heart attacks and strokes, and help people lead longer, heathier lives, that’s a major finding,” she said.
Low Wang also chairs the committee that advises the U.S. Food and Drug Administration (FDA) on drugs related to endocrinology and metabolism. The FDA approved Wegovy in June of 2021, marking the first time since 2014 that federal health authorities had given the green light to a new weight loss drug.
(Low Wang’s views do not represent those of the FDA or the FDA Endocrinologic and Metabolic Drugs Advisory Committee. Nor did she have any involvement in the recent study.)
The drug maker for Wegovy and Ozempic, Novo Nordisk, recently shared details of the cardiovascular study in the New England Journal of Medicine and at an international conference in Amsterdam.
To learn more about the newest research about weight loss drugs, we checked in with Low Wang.
How big a deal are the findings from the Wegovy cardiovascular study?
Low Wang said the results are, indeed, a big deal. That’s because the effect — reducing serious cardiovascular events by about 20% — is so pronounced. And no previous weight loss drugs have been proven to reduce strokes and heart attacks or prevent cardiac deaths.
The degree of reduction in adverse cardiac events was greater than expected, Low Wang said.
A 20% reduction in cardiac events is especially noteworthy because people who already have cardiovascular disease are at much greater risk for suffering another heart attack, stroke or other cardiovascular event.
“We know that their risk of another event is really, really high,” Low Wang said.
To help people with these risks, doctors encourage people to change their lifestyles, eat a heart-healthy diet and exercise consistently. They often also prescribe medications to lower their blood pressure and cholesterol.
“There are a number of agents that we know can reduce your risk, but to have a drug that is being used for weight management give you another 20% reduction in risk is big news,” she said.
Do you think evidence of cardiovascular benefits — if they can be duplicated — might lead to better insurance coverage for medications like Wegovy, Ozempic and Mounjaro?
Yes. Low Wang expects insurance companies, private employers and federal health insurance programs like Medicare and Medicaid to reevaluate coverage for the new weight loss drugs. That’s because cardiovascular health problems are common and costly. If research continues to show that the new weight loss drugs not only make it easier for patients to lose weight but also to dramatically reduce adverse cardiovascular events, health insurance companies may be forced to expand coverage, and drug makers might need to reduce prices.
“Right now, some insurance companies and employers are dropping coverage for these weight loss drugs because of the cost since a large number of people need them,” Low Wang said. “I think they’re looking at their bottom lines and saying, ‘This is not sustainable.’
“But if these drugs are also proven to prevent and reduce cardiovascular events, then the decisions may be different,” Low Wang said. “I’m hoping the new research helps with expanded coverage.”
What were the findings of this Wegovy cardiovascular study?
The drug maker, Novo Nordisk, conducted the study. Researchers compared the effects of the highest dose of semaglutide — a 2.4 mg. injection — to a placebo injection.
The study was a large international clinical trial that included 17,604 adults, ages 45 and older, who live in 41 countries. The study began back in 2018 long before most members of the public had ever heard of semaglutide.
The study volunteers were either overweight or obese but did not have diabetes. The researchers were trying to determine if Wegovy injections could reduce or prevent major adverse cardiovascular events. (Wegovy and Ozempic are different names for the same drug — semaglutide. Ozempic is formulated and approved for the treatment of diabetes. Wegovy is prescribed to help people lose weight.)
The adverse cardiovascular events that researchers hoped to prevent included strokes, heart attacks and deaths from cardiovascular causes including coronary artery disease and sudden cardiac death.
Researchers found that study participants who received semaglutide rather than the placebo suffered fewer adverse cardiovascular events.
The study participants who received Wegovy vs. the placebo also lost considerably more weight, with those who received the study medication losing an average of more than 13% of their body weight compared to a nearly 3% reduction in body weight for volunteers who received the placebo.
How did the study subjects receive semaglutide or a placebo?
They were given once-weekly injections. The drug maker, Novo Nordisk, is now testing a pill form of the medication.
Why is this cardiovascular study significant?
Researchers and patients who have used the new weight loss drugs already have found that the drugs help reduce food cravings and can lead to dramatic weight loss.
But no other previous weight loss drugs also have been proven to dramatically reduce the risk of death or adverse events from cardiovascular events like heart attacks and strokes.
Many people who are overweight or obese are at greater risk for dangerous cardiovascular events like heart attacks and strokes. So, a drug that could help with both obesity and cardiovascular health challenges could be invaluable.
Can we trust the study results given that the company that makes Wegovy and Ozempic funded the study and wants big sales of the drugs?
It is true that the drug company that created Wegovy and Ozempic conducted this cardiovascular study.
Low Wang said it’s wise to pay attention to funding for scientific research.
“It’s important to ask about conflicts. There are trials that are not well conducted and are very, very biased,” she said.
In this case, however, the cardiovascular study was a large, international effort that enlisted the help of researchers across the world, with a study designed to minimize bias.
Because of the study design, she said this was a high quality study. (Low Wang was not involved in the clinical trial.)
“This was a double-blind, randomized, placebo-controlled trial, so people received the medication or the placebo, and neither the researchers nor the patients in the trial knew whether people were getting the study medication or not,” she said. “There are guardrails and trial structure built into a clinical trial like this to minimize bias.”
The drug maker, Novo Nordisk, will share their findings and data publicly. In order for this drug to be prescribed to reduce cardiovascular risk, the drug maker would need to provide the data to the FDA for review. Also, other researchers will closely examine the study’s findings. Therefore, Low Wang thinks the data are likely to be sound.
There is no doubt that the new weight loss drugs have become a huge financial windfall for Novo Nordisk and likely will also generate profits for competitors like Lily, which makes another new weight loss drug, Mounjaro. Novo Nordisk is based in Denmark, and a recent report highlighted the outsized impact that the success of weight loss drugs is having on Denmark’s economy.
What dose of Wegovy or semaglutide did the study participants receive?
In the clinical trial, study participants received the largest dose of semaglutide or Wegovy: a 2.4 mg injection once a week.
Doctors typically start patients on lower doses of semaglutide since the drug can cause gastrointestinal side effects. Then they gradually build up to larger doses.
What are the pros and cons for using these new weight loss medications.
There are several pros and cons. (Read more about Wegovy vs. Ozempic. And learn about a competing drug, Mounjaro.)
The pros of weight loss medications like Wegovy and Ozempic include:
- Dramatic weight loss.
- Reduced food cravings.
- Reductions in adverse cardiovascular events like heart attacks, strokes and sudden cardiac death.
- Improved ability to enjoy physical activities.
- Reduced risk of diabetes.
The cons of medications like Wegovy and Ozempic include:
- Cost: the medications can cost $1,000 or more per month and often are not covered through health insurance.
- Permanent reliance on medications: If people lose weight with the new drugs, they likely will need to keep taking them forever.
- Shortages due to popularity of the medications.
- Possible bad gastrointestinal side effects including diarrhea, stomach aches and bloating.
- An eye problem called retinopathy that has surfaced in some cases.
How large an impact are new weight loss drugs having on patients and medical providers?
The newest drugs — with several more on the horizon — could have a big impact on the treatment of obesity in the U.S.
In the past, people who were overweight or struggling with obesity had been blamed for carrying extra weight. Now, most experts are viewing obesity as a medical issue, and they’re much more likely to consider biochemical causes for obesity.
Another big change is that the newest drugs work better. In the past, weight loss medications didn’t produce dramatic weight loss, so a very low percentage of patients who might have benefited used them, Low Wang said.
“These newer weight loss medications are much more effective than anything we’ve had before,” Low Wang said. “This is a new era.
“The biggest barriers now are cost, access and supply,” Low Wang said. “But for people who have obesity — and especially those with established cardiovascular disease — there may be an even stronger argument for the use of these drugs.”
What trends are you seeing among your patients?
Low Wang has patients who are trying the new weight loss drugs, but many are experiencing shortages, especially for the higher doses, like the 2.4 mg. dose that was used for the cardiovascular study.
Many patients are also struggling to pay for their medications or to get health insurance coverage for new weight loss medications.
What’s your overall message for patients who are considering using weight loss medications?
For people who are overweight or dealing with obesity, and who also are at risk for cardiac events like heart attacks, strokes and sudden cardiac death, the newest drugs may be quite helpful.
“There could probably be a substantial benefit,” Low Wang said.
She also hopes that everyone who needs the medications — including more low-income patients and people of color — will be able to access them.
Many people who are at greater risk for obesity, diabetes and cardiovascular health challenges are people of color. Low Wang is especially mindful that historically disadvantaged people may need help getting access to expensive new medications.
“People of color are disproportionately affected by excess weight, diabetes and adverse cardiovascular outcomes,” she said. “We have to be working at every level to mitigate or reduce current risks. And we also need to be thinking about prevention.
“How do we change our built environment and our communities to promote access to healthy foods and safe places to exercise?”