Boxes of Ozempic and Wegovy made by Novo Nordisk are seen at a pharmacy in London, Britain March 8, 2024.Hollie Adams/Reuters
Semaglutide, the medication better known as Ozempic, reduces the symptoms of a condition that can lead to lower limb amputations in people with diabetes, according to a new study that reinforces the benefits of the popular drug beyond weight loss.
The results of the clinical trial, which was co-led by a Canadian doctor, show that semaglutide improved quality of life and increased the distance that participants could walk without the debilitating calf cramping that is a hallmark of peripheral artery disease, or PAD.
The study was released Saturday in medical journal The Lancet.
“This is another piece of great news for our patients living with diabetes,” said Lawrence Leiter, an endocrinologist at St. Michael’s Hospital in Toronto who was not involved in the study.
“Semaglutide, or Ozempic, is already widely used in the treatment of diabetes. It was originally developed as a drug to lower blood sugar. Then, of course, it has been shown to have significant benefits with regards to weight. Then it was shown to reduce the risk of heart attacks and strokes and reduce the risk of advanced kidney disease. And now we have yet another advantage of this medication.”
Between 10 and 20 per cent of patients with diabetes develop peripheral artery disease, said Dr. Leiter, who is also a professor of medicine and nutritional sciences at the University of Toronto.
It arises when narrowed arteries restrict blood flow to the arms and legs. Diabetes raises the risk of PAD, but the condition can afflict people without diabetes as well.
In its early stages, PAD manifests as tingling, numbness and cramping in the legs, making it difficult to walk much. As the disease progresses, patients sometimes develop wounds that refuse to heal because there isn’t sufficient blood flow to their lower legs and feet. The worst cases lead to limb loss.
“Amputations for diabetes are on the rise, and usual treatments for diabetes have not necessarily resulted in improvements in this outcome,” said Subodh Verma, the cardiac surgeon and scientist at St. Michael’s who co-led the international trial. “And it’s the most feared complication in diabetes.”
However, the clinical trial, called STRIDE, was not designed to see whether semaglutide reduced the risk of lower limb loss. Its purpose was to determine whether the drug, which belongs to a class called GLP-1 receptor agonists, could reduce the symptoms of PAD in people with mild to moderate symptoms early in the course of their disease.
The trial divided 792 participants with diabetes and PAD into two groups, half of whom received injections of semaglutide. The rest received a placebo.
A year later, the people who took semaglutide could walk farther on a treadmill without pain than those who had taken the placebo.
The semaglutide patients also reported better quality of life, and showed improvements in their ankle-brachial indices, a test that compares blood pressure in the arm and ankle as a proxy for measuring blood flow to the lower limbs.
The study was paid for by the Danish pharmaceutical giant Novo Nordisk, maker of Ozempic and Wegovy, the higher-dose version of semaglutide marketed for weight management.
Drs. Leiter and Verma have both disclosed receiving funding from the company.
Dr. Verma said the benefits of the drug for early stage PAD appeared to be mostly independent of weight loss.
The trial did not recruit for obesity. The median body mass index of the participants was 28, which is considered overweight but not obese. Patients in the semaglutide group lost, on average, four kilograms more than people in the placebo group during the one-year study, but some who lost little or no weight still saw their PAD symptoms improve.
“The story of semaglutide is much more than weight,” Dr. Verma said. “This is a disease-modifying therapy.”
The bottom line, he added, is that “we have a new treatment for PAD, and we just have to see how Health Canada, the global guidelines and others incorporate this into their practice.”
