A large new study published in the New England Journal of Medicine found that the popular weight loss drug Wegovy significantly reduced the risk of serious heart problems in overweight or obese people already at high cardiac risk.
The global clinical trial, funded by Novo Nordisk which makes Wegovy, involved over 17,600 participants aged 45 and older who had preexisting heart conditions. They were randomly assigned to receive weekly injections of Wegovy or a placebo, in addition to their regular heart medications.
Key Findings: 20% Lower Risk of Heart Events
After following the participants for over 3 years on average, researchers found that those who took Wegovy had a 20% lower risk of heart attack, stroke, or death from heart-related causes compared to the placebo group.
Specifically, 6.5% of the Wegovy group (569 people) versus 8% of the placebo group (701 people) experienced one of those major adverse heart events during the study.
This risk reduction is significant, considering all participants already had high cardiac risk factors like obesity, heart attack history, hypertension, high cholesterol, etc.
Weight Loss and Improved Heart Health Markers
Participants who took Wegovy lost around 9% of their body weight on average, while the placebo group had minimal weight change. The weight loss was accompanied by improvements in several key markers of heart health:
- Lower inflammation levels
- Reduced LDL “bad” cholesterol
- Lower blood sugar
- Reduced blood pressure
- Smaller waist circumference
These metabolic changes likely contributed to the reduced heart event risk, though the drug may also provide direct cardiovascular benefits.
First Evidence for Heart Benefits of Obesity Drugs
This clinical trial offers the first concrete evidence that an obesity medication can safely prevent serious heart complications in at-risk individuals.
Previous research has shown weight loss improves cardiovascular health. But until now, there was no obesity drug proven to reduce specific heart risks.
The findings are likely to change clinical practice guidelines and fuel wider insurance coverage of weight loss medications for appropriate patients. Heart specialists say the data will dominate discussion in the cardiology field for years.
Study Limitations and Critiques
The landmark study had some limitations. The participants were mostly white males, reducing diversity. It’s unclear how much of the benefit was from weight loss versus a direct drug effect.
There were also more side effects in the Wegovy group, though most were gastrointestinal issues. About 17% on Wegovy withdrew from the study, compared to 8% on placebo.
Some experts critique that the high cost of Wegovy, around $1300 per month, could limit access especially given inconsistent insurance coverage of weight loss drugs.
Insurance Coverage and Cost Implications
Currently, private insurers often deny coverage of obesity medications or impose strict requirements. And Medicare is prohibited by law from covering drugs solely for weight loss.
But with demonstrated heart benefits, Novo Nordisk plans to apply to the FDA to add the new data to Wegovy’s label. This could prompt payers to loosen restrictions for appropriate patients with obesity and high cardiac risk.
Advocates argue Congress should mandate Medicare coverage for obesity drugs, given the proven risk reduction. But cost concerns remain an access barrier for many patients. Heart specialists say insurers should cover these medications as they would other drugs that improve health in at-risk groups.
Cautious Prescribing Still Needed
Experts caution the study results don’t mean weight loss drugs like Wegovy should now be widely prescribed. Heart specialists emphasize they are not recommending the drugs for people simply looking to lose a few pounds.
The participants were obese with BMI over 27 and had serious heart conditions like heart attack history. Prescribing should be judicious based on a patient’s complete health profile and only along with lifestyle changes.
But for high-risk individuals who struggle with obesity despite diet and exercise, Wegovy and related drugs could now be considered along with other therapeutic options. Patients should discuss benefits and risks with their doctor.
Future Research Directions
More research is still needed on the long-term safety and optimal prescribing of weight loss medications. Future studies should also aim for more demographic diversity.
It’s unclear if other groups like younger or healthy obese individuals would have similar heart benefits from drugs like Wegovy. Future research could help identify patients most likely to benefit from cardioprotective effects.
Investigating potential differences between specific obesity drugs will also be important. For example, does Wegovy confer advantages over other options like Saxenda or Ozempic? Head-to-head studies are lacking currently.
Nonetheless, the field of obesity pharmacotherapy has reached an important milestone with the first compelling evidence of reduced heart risk in vulnerable patients. This could make weight loss drugs an increasingly valuable addition to comprehensive care for suitable individuals with obesity.