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The weight-loss drug Wegovy might help folks with pre-existing coronary heart situations keep away from a repeat coronary heart assault or stroke, in keeping with a examine introduced Saturday at a medical convention.
The examine, funded by the drug’s producer Novo Nordisk, discovered a 20% discount in coronary heart assault and stroke threat amongst sufferers whose physique mass index, or BMI, is excessive sufficient to be thought of “overweight” or “obese.” Previously, the identical profit had been proven in high-risk folks with kind 2 diabetes and comparatively excessive BMI.
All of the examine topics had been already receiving standard-of-care remedy, so the profit is on prime of what would already be anticipated in folks taking remedy for hypertension and excessive ldl cholesterol.
“Now, when we have patients who have overweight and obesity but not diabetes, this is going to be on our radar,” mentioned Dr. Michael Lincoff, the Cleveland Clinic heart specialist who led the analysis, which was published simultaneously in the New England Journal of Medicine.
The findings recommend the most recent class of weight-loss medication gives well being advantages that have not been seen with earlier medicines. Several earlier weight-loss medication, together with fen-phen and sibutramine, contributed to cardiovascular issues and were taken off the market.
The largest influence of the examine, Lincoff and others mentioned, could include insurance coverage protection.
“This is a trial that’s going to change reimbursement,” mentioned Dr. Eric Topol, a heart specialist and founding director of the Scripps Research Translational Institute.
The Centers for Medicare & Medicaid Services, or CMS, could have a tough time saying no to a drug that reduces the possibility of a second coronary heart assault or stroke for somebody already at excessive threat, he mentioned. Neither CMS nor many personal insurance coverage at the moment cowl the price of weight-loss medicines.
But Topol is anxious that the excessive price of Wegovy, which retails at greater than $1,300 per 30 days, is “going to break the bank,” as soon as Novo Nordisk resolves the availability points which have plagued it for the final two years.
Lincoff mentioned that is an issue for one more day.
“Half the battle is proving the science. The other half of the battle is having to implement what’s been proven,” he mentioned. “You’ve got to start off by proving it. That’s what we’ve done, in a convincing fashion, now.”
Providing a well being profit
In the previous, weight problems medicines mixed with life-style change, have helped folks cut back their physique weight by solely about 5% to 10%.
Although added weight is taken into account to extend well being dangers, the form of long-term weight reduction that gives substantial medical profit ‒ 15% to twenty% of physique weight ‒ has been out of attain for the overwhelming majority of individuals, until they go for bariatric surgical procedure.
But Wegovy and another drug approved this week called Zepbound from Eli Lilly provide the promise of even larger weight reduction. The highest dose of Wegovy has been proven to assist folks lose about 15% of physique weight when mixed with common train and a nutritious diet. With Zepbound’s highest dose, it is over 20%. (The new examine solely examined Wegovy, not Zepbound, so it is not clear whether or not Zepbound would have the identical coronary heart advantages.)
In this examine, individuals misplaced solely about 9% of their physique weight on common, but nonetheless noticed a profit. Lincoff mentioned he thinks they did not lose extra as a result of the examine was led by cardiologists like him, somewhat than by weight problems medication specialists who would have prioritized life-style adjustments.
The comparatively small weight reduction and the fast discount in stroke and coronary heart assault recommend that the well being advantages of Wegovy come each from the burden loss and the drugs itself, Lincoff mentioned. In examine individuals, the drug decreased blood stress and indicators of irritation and in lab research, it had a direct impact on the guts muscle and partitions of blood vessels and arteries, he mentioned, probably explaining the discount seen in strokes and coronary heart assaults.
Topol mentioned he was most impressed by the drug’s enchancment in metabolic well being. Half the individuals taking a placebo had irregular blood sugar ranges on the finish of the trial, in contrast with solely 21% within the group taking the drug.
“There really was a very profound effect on preventing people from moving into diabetes, which is encouraging,” he mentioned.
Wegovy, which is the model identify for the drug semaglutide offered for weight reduction, was examined in sufferers 45 and older who had preexisting heart problems and a BMI of 27 or larger however no historical past of diabetes. More than 17,000 folks in 41 nations had been enrolled and adopted for a median of greater than three years after being randomly assigned to obtain weekly injections of semaglutide at 2.4 mg or an identical placebo.
Results of the trial, referred to as SELECT for “Semaglutide and Cardiovascular Outcomes in Patients with Overweight or Obesity Who Do Not Have Diabetes” were set to be presented Saturday at the American Heart Association’s Scientific Sessions 2023 in Philadelphia.
“We do consider that the outcomes of SELECT maintain immense worth ‒ not just for folks affected by weight problems but in addition healthcare professionals, determination makers, and it has the potential to basically change how we understand weight problems as a severe persistent illness and never simply as a life-style situation,” Dr. Martin Holst Lange, Novo Nordisk’s executive vice president of development said in an interview.
The company is also testing semaglutide in people with a relatively high BMI who are at risk for liver disease, peripheral artery disease and arthritis.
A trial in people with diabetes and chronic kidney disease was stopped early recently by an independent assessor because it was so effective that it would be considered unethical to continue giving participants a placebo. Detailed results of that trial will become public early next year.
The biggest piece missing in the public’s understanding of semaglutide and other drugs in a new class called incretins is their long-term effect, experts say.
The SELECT trial is the longest to date in people without diabetes. It followed people for 40 months, but the drugs are intended to be taken for life, just as high blood pressure and cholesterol-lowering drugs are.
Early research from Novo Nordisk and other companies suggests people regain weight when they stop the medications.
Topol said he worries what might happen when people at high risk for heart disease are no longer willing or able to give themselves weekly injections or afford their Wegovy.
“For all we all know,” he said, “the rebound may very well be worse.”
Contact Karen Weintraub at kweintraub@usatoday.com.
Health and patient safety coverage at USA TODAY is made possible in part by a grant from the Masimo Foundation for Ethics, Innovation and Competition in Healthcare. The Masimo Foundation does not provide editorial input.
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