Wegovy, not yet available in Brazil, was approved by the FDA to prevent heart attacks and strokes in adults.

In a study, the drug reduced the risk of serious cardiovascular events by 20% in overweight or obese people for a period of up to five years.

Indicated for the treatment of obesity, semaglutide 2.4 mg, trade name Wegovy, received approval in the United States to reduce the risk of complications and death from cardiovascular diseases, such as heart attack and stroke, in adults who live with overweight or obesity.

The approval of the Food and Drug Administration (FDA), an American regulatory agency, considered a study that showed that the drug from Danish pharmaceutical company Novo Nordisk is capable of reducing the risk of serious cardiovascular events by 20% for a period of up to five years.

In a note published last Friday, 8, John Sharretts, director of the Division of Diabetes, Lipid Disorders and Obesity at the FDA’s Center for Drug Evaluation and Research, stated that the drug is the “first weight loss medication to be also approved to help prevent potentially fatal cardiovascular events.” The agency recommends that treatment includes a  low-calorie diet and increased physical activity.

“This patient population is at increased risk of cardiovascular death, heart attack and stroke. Providing a treatment option that has been proven to reduce this cardiovascular risk  is a major advance for public health,” he added.

According to the FDA, among volunteers who received the drug, the reduction in the risk of cardiovascular events was 6.5%. In the placebo group, it was 8%.

“The data demonstrated that Wegovy has the potential to prolong lives by addressing some of the leading causes of preventable deaths and reducing the risk of cardiovascular events,” said  Martin Holst Lange, Executive Vice President and Head of Development at the Danish pharmaceutical company in a statement. .

Semaglutide is part of a class of medications that are among scientists’ bets as a potent weapon against obesity: substances that act on hormone receptors produced by the intestines, such as GLP-1, linked to appetite regulation and rhythm reduction. stomach emptying, thus increasing the duration of the feeling of satiety. Side effects include  gastrointestinal changes, such as nausea, diarrhea, vomiting, constipation and abdominal pain.

Studies with Wegovy

The study that supported the approval, called Select, was released in August last year and began in 2018 with 17,600 patients over 45 years old and overweight or obese, in addition to established cardiovascular disease, but without a diagnosis of type diabetes. two.

Researchers compared weekly subcutaneous application of semaglutide 2.4 mg with placebo in an analysis carried out in 41 countries at more than 800 research centers. In Brazil, 600  volunteers participated in the trial. The idea was to evaluate whether the drug would have a protective effect against serious adverse cardiovascular events (MACEs).

In the same month, Novo Nordisk released another trial showing that the drug reduced symptoms of heart failure in patients who, in addition to the disease, live with obesity. Weekly injections applied  over a year improved fatigue, physical limitations, exercise tolerance and swelling in the extremities of the body.

Wegovy in Brazil

In Brazil, the medicine was approved by the National Health Surveillance Agency (Anvisa) only for people with overweight (and comorbidities) and obesity in January last year. However, with the high demand and to avoid the risk of shortages, the pharmaceutical company has not yet announced when it will be available in the country.

According to the Danish company, tests showed that the drug was able to reduce body weight by up to 17% in 68 weeks. Also according to the company, the treatment – ​​carried out with weekly injections – helped to reduce the body weight of one in every three people by 20% and 83.5% of patients showed a weight loss equal to or greater than 5%. 

Semaglutide for other diseases

Semaglutide is also being investigated in studies for the treatment of other conditions, such as Alzheimer’s disease,  controlling alcoholism and reducing liver fat.

This month, the Flow study found that semaglutide 1 mg (Ozempic) is capable of reducing the risk of kidney disease in patients with type 2 diabetes by 24%. According to the company, chronic kidney disease is present in 40% of patients who live with diabetes, which is why they requested the expansion of the Ozempic package insert in the United States and the  European Union.

Trials have shown encouraging results for metabolic problems caused by antiretroviral treatments indicated for people living with HIV. An article published this Monday, 11th, in the scientific journal Nature showed results for weight loss and a reduction in hepatic steatosis (fat in the liver). According to the phase 2 clinical trial, carried out in the United States  and Brazil, there was a reduction in liver fat in 31% of volunteers, of which 29% showed resolution of the condition, reaching levels suitable for health.

Source: Veja.abril