The findings from Wegovy's extended clinical trial discuss weight reduction, potential adverse effects, and cardiovascular safety.
The new analyses of the Select trial, which revealed a year ago that Wegovy reduces heart risk while aiding in weight loss, prompt discussions about how the popular GLP-1 receptor agonists might safeguard the heart beyond simply managing weight.
Dr. Harlan Krumholz, a cardiologist and researcher at Yale University and Yale New Haven Hospital not involved in the research, considered this development "profound." Moreover, he stated on Tuesday that another study reported similar benefits for heart failure. "We haven't found any medication with such heart-benefiting benefits," he added.
With over 25,000 people starting Wego cover this every week, according to drugmaker Novo Nordisk, and a separate KFF poll indicating that 6% or 15+ million citizens (50,000 of them respondents) were using these drugs, the implications of these findings come with shifting questions regarding the use and insurance coverage of these meds.
The Select trial, which received funding from Novo Nordisk, initially demonstrated Wegovy's ability to reduce the risk of heart attacks, strokes, and heart-related deaths in high-risk individuals (including those with obesity or excess weight) by 20% through more than 17,600 participants from 41 countries between 2018 and 2021. The researchers now spotlighted the sustained benefits of the drug up to four years.
The latest results showed that the average weight loss for Wegovy users was 10.2% as opposed to 1.5% for placebo recipients. From the onset of the trial, Wegovy users saw steady weight loss for about 65 weeks, or a year and 3 months, before reaching stability.
In a parallel clinical trial, the average weight loss peaked at 14.9% compared to 2.4% for those receiving a placebo, however, this study focused solely on weight and included more structured diet, exercise, and lifestyle strategies.
The results demonstrated the sustained 10% average weight loss for people using Wegovy held out for the full four-year follow-up.
The weight loss maintenance statistics differed among the participants based on whether they continued Wegovy or switched to a placebo. Those who stayed on the medication lost an additional weight on average, whereas those who weren't aware of the switch experienced regained weight.
While the average weight loss numbers from the studies are common, researchers accentuated the obvious fact that everyone responds differently and, therefore, each patient's experience with drugs varies considerably.
After two years of treatment, 68% of Wegovy users successfully lost 5% of their initial body weight, making it an impressive figure compared to 21% for participants on a placebo. The individuals on the active medicine also experienced a notable 22.5% weight reduction, whereas patients on control lost roughly 1.7% of their weight, once again emphasizing that the trial's average findings aren't indicative of the usual patient outcome.
Drug-related side effects led to more discontinuation with the trial for participants on Wegovy (17%) than those who received a placebo (8%). The typical side effects, mostly concerning the gastrointestinal system, appeared during the initial period of dose escalation. [side effects like nausea, diarrhea, vomiting, and constipation].
The recent study revealed that there were no new safety issues related to Wegovy in the recent analysis. Although acute pancreatitis, or inflammation of the pancreas, was not observed at a higher rate in Wegovy-treated participants compared to placebo, gallbladder problems like gallstones were found to be higher: 2.8% for Wegovy users versus 2.3% for placebo. Both these issues are included in the drug's safety information since they were reported earlier during its trials.
Additional advantages beyond weight loss
A significant query following the presentation of the Select trial's full results was whether the 20% drop in the heart risk was due to weight loss alone or some other protection offered by the drug. The new analysis sheds light on this query.
It seems that the reduced risk of cardiovascular events wasn't solely due to weight loss. The benefits were also observed among Wegovy users who didn't lose weight.
According to Dr. Daniel Drucker, a University of Toronto researcher who specializes in GLP-1, these drugs provide cardiovascular advantages apart from weight loss. Drucker explained that GLP-1 is cardio-protective in animals, irrespective of whether the subjects have diabetes, obesity, or don't need to lose weight.
An investigation led by John Deanfield from the University College London showed that the decrease in cardiovascular adverse events in the study involving Wegovy compared to placebo was similar among participants who lost 5% or more of their body weight, those who lost less than that, and those who gained weight. The researchers concluded that there are other pathways for improved cardiovascular outcomes than just reducing adiposity.
Another study published on Monday about heart failure, with which Wegovy has shown substantial benefits, supports the same conclusion. Krumholz said in an email, "These two studies suggest that anti-obesity medications are also heart-health drugs. The benefits for the heart in people with existing cardiovascular ailments or heart failure happen regardless of the amount of weight loss."
Possible mechanism: Reduction in Inflammation
Drucker thinks that GLP-1 drugs provide these advantages by decreasing inflammation. "We can't deny the blood pressure and triglyceride reduction, and the body weight loss must help a bit. But based on our lab's research, I believe that one of my favorite theories is inflammation, because we know that people with heart disease have increased inflammation in their blood vessels and hearts."
Drucker mentioned that numerous studies have shown that GLP-1 drugs help to diminish harmful inflammation, and his lab is researching it. He also pointed out that people with various conditions caused by inflammation, such as Covid-related brain fog, ulcerative colitis, and arthritis, believe that their symptoms improved while on GLP-1 medications. However, these observations need to be confirmed in clinical studies to be considered conclusive.
The findings in the Select trial bring the question of whether people who don't have obesity or aren't overweight but have experienced a heart attack or stroke could benefit from taking a drug like Wegovy to prevent another incident. This too requires further research.
Moreover, Drucker emphasized that insurers should broaden their coverage for these medications, which cost around $1000 or more per month without insurance, since they're beneficial for improving health, saving lives, and saving healthcare costs even for individuals without weight loss. "We really need to reconsider these criteria for reimbursing the medicines because they're not just helpful in terms of improving health and saving lives and healthcare dollars, but also don't require weight loss to reduce heart attacks, strokes, and death."
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The new study further highlights that the cardiovascular benefits of Wegovy aren't solely dependent on weight loss, as it shows similar improvements in participants who gained weight. Furthermore, Dr. Drucker suggests that GLP-1 drugs might provide heart advantages through reducing inflammation, which is a common issue in individuals with heart disease.
Source: edition.cnn.com
