PHILADELPHIA — On the latest American Coronary heart Affiliation assembly, a cavernous room stuffed with medical doctors erupted into applause. Cleveland Clinic heart specialist A. Michael Lincoff had simply introduced the dramatic — and at instances enigmatic — outcomes of a brand new scientific trial on the load loss drug semaglutide.
The drug, bought underneath the model identify Wegovy, lower sufferers’ threat of main cardiovascular issues by 20 %, Lincoff reported November 11. It additionally lowered the chance of dying — from any trigger — over the roughly 40 months sufferers participated within the examine on common.
Lincoff’s work notches one more position for semaglutide, which medical doctors at present use to deal with diabetes and weight problems. Earlier work had already uncovered a cardiovascular profit in individuals with kind 2 diabetes. The brand new examine, which focused chubby or overweight sufferers with heart problems, is the primary to point out that semaglutide may also help the hearts of individuals with out diabetes too.
That’s essential as a result of it expands the quantity of people that may benefit from the drug, says Tiffany Powell-Wiley, a heart specialist and epidemiologist on the Nationwide Coronary heart, Lung and Blood Institute in Bethesda, Md. In the US alone, greater than 6 million overweight or chubby individuals have heart problems however not diabetes. Semaglutide could possibly be a sport changer for these individuals, says Powell-Wiley, who was not a part of the brand new trial. Nonetheless, she and others on the assembly acknowledged the restrictions of the examine — and the restrictions of the drug.
As a lot as we could need a fast repair for the rising ranges of weight problems seen all over the world, Powell-Wiley says, “it’s essential to know that this isn’t the panacea.” We nonetheless don’t know the way properly semaglutide works in a various group of individuals, she says. And the drug doesn’t repair the societal, environmental and social components that result in weight problems — and its potential well being penalties — within the first place.
Semaglutide lowered the chance of coronary heart assault, stroke and loss of life
Semaglutide is one amongst a household of medicine gaining reputation for treating weight problems. On November 8, the U.S. Meals and Drug Administration accepted a brand new one: tirzepatide, a relative of semaglutide that goes by the model identify Zepbound. [See also: Semaglutide FAQ ]
Semaglutide, bought underneath the model identify Ozempic, first got here in the marketplace for treating diabetes in 2017. Since then, the drug’s slew of makes use of has saved rising. In 2020, the FDA OK’d it for chopping cardiovascular threat in individuals with diabetes and coronary heart illness. And in 2021, therapy for weight problems (with the upper dose Wegovy) joined the listing.
Lincoff’s semaglutide trial, known as SELECT, included greater than 17,000 individuals, half of whom acquired weekly injections of semaglutide for roughly three years; the opposite half received a placebo. By the tip of the trial, 8 % of the individuals within the placebo group had had a nonfatal stroke or coronary heart assault or died as a result of cardiovascular causes. That quantity dropped to six.5 % within the semaglutide group, Lincoff reported on the assembly and on-line November 11 within the New England Journal of Drugs.
The distinction between the 2 teams could not sound like a lot, however “it’s an enormous outcome,” says Amit Khera, a heart specialist at UT Southwestern Medical Heart in Dallas who was not a part of the trial. One can’t underestimate the significance of discovering a brand new therapy for sufferers with heart problems, he says.
The sickness is “the biggest supply of mortality on the planet,” Lincoff mentioned at a information convention on November 10, and there’s no single remedy that may remove it. As a substitute, medical doctors attempt to chip away at it with numerous remedies that provide incremental advantages.
For chubby or overweight individuals with coronary heart illness, Khera says, semaglutide is one other software in cardiologists’ toolkits.
Questions stay about how the drug works — and for whom
The brand new examine outcomes flesh out earlier information of the trial launched by funder Novo Nordisk in August (SN: 8/29/23). On the time, medical doctors needed to know who the drug helped, the way it labored and what negative effects it set off. The newest report presents solutions to some questions however kicks others vast open.
Members on semaglutide have been barely extra prone to drop out of the trial than these taking the placebo. That distinction gave the impression to be pushed by the drug’s gastrointestinal negative effects, which embrace nausea, diarrhea and vomiting. The variety of critical points that occurred, like most cancers or an infection, was barely decrease within the semaglutide group.
Although semaglutide supplied clear cardiovascular advantages for sufferers, one mysterious facet of the information snagged researchers’ consideration. The drug’s protecting results grew to become obvious early within the trial — properly earlier than individuals had shed plenty of kilos.
That’s a giant deal as a result of it suggests semaglutide could also be boosting coronary heart well being immediately, maybe along with the everyday advantages that accompany weight reduction, says Caroline Apovian, an weight problems medication specialist at Harvard Medical College and Brigham and Ladies’s Hospital in Boston. She was not concerned within the examine however is on Novo Nordisk’s scientific advisory board. Lincoff mentioned his crew is “working feverishly” on analyzing the SELECT information to raised perceive semaglutide’s actions.
These information embrace demographic and medical info on hundreds of trial individuals. However the trial does have one “big limitation,” says Powell-Wiley: 84 % of the examine’s individuals have been white and 72 % have been males.
Increasing the range of individuals represented in scientific trials like these is essential, she mentioned. It’s some extent she introduced up in a panel dialogue after Lincoff’s speak, and one which — just like the trial’s outcomes — garnered widespread applause. In the US, African-American, Hispanic and Indigenous persons are most impacted by weight problems, Powell-Wiley says, and the brand new trial doesn’t inform us a lot about how semaglutide works in these teams.
