Study investigates whether diabetes drug reduces heart disease in obese people

A new study in progress seeks to understand whether semaglutide, the active ingredient of a drug authorized in Brazil for the treatment of type 2 diabetes, has positive effects in reducing cardiovascular disease in people with obesity.

In total, more than 17,000 people participated in the survey around the world – around 600 are from Brazil.

Semaglutide was initially researched only for the treatment of type 2 diabetes. But benefits of the substance have been observed for other conditions, such as obesity and reduction of heart complications.

The active principle has some actions in the body that collaborate in weight loss. One of them is to increase the feeling of satiety and reduce appetite. As a result, the patient loses weight. Research has already observed a reduction of about 15% in weight after 68 weeks of use of the drug.

“What we had of medicine until today for the treatment of obesity was little effective. I mean, they lost little weight and had a collection of side effects”, says Otávio Rizzi, cardiologist and professor at Unicamp (University of Campinas).

There is also evidence that semaglutide has positive effects in reducing cardiovascular complications in patients with type 2 diabetes. Obesity is strongly associated with the development of heart problems by causing the accumulation of fat in the blood vessels.

Similarly, excess weight also influences the onset of diabetes, a disease that poses a risk for heart complications. “Being diabetic more than doubles the chance of infarction and stroke”, says João Monteiro Ferreira, president of the board of directors of the SBC (Brazilian Society of Cardiology).

Therefore, proper treatment of diabetes and obesity means a decrease in heart complications.

The relationship between these conditions is already better explored among medical specialties. One example was the European Society of Cardiology (ESC) congress, which took place in Barcelona, ​​where events were organized to address the association between diabetes, obesity and cardiovascular disease.

“Among us cardiologists, we didn’t worry about controlling obesity because we didn’t know how to do that. It was restricted to endocrinologists, who also didn’t have great results. Now it’s become my problem. have heart failure or hypertension and who are obese,” says Rizzi.

So far, all studies that have investigated the effects of semaglutide have included patients with a positive diagnosis of diabetes. Now, the new investigation — called Select (effects of semaglutide on heart disease and stroke in overweight or obese patients) — wants to look at outcomes for heart complications in those with obesity alone.

Although there are expectations that semaglutide will also result in cardiac benefits in the case of non-diabetic patients, new scientific evidence is still needed, such as the results of the Select that should be released in late 2023.

Without definition

So far, the drug with semaglutide as the active ingredient marketed in Brazil is ozempic. It is only indicated for the treatment of type 2 diabetes.

An application has already been filed with Anvisa (National Health Surveillance Agency) in order to authorize the marketing of wegovy, a version with a different dosage of semaglutide and which is indicated for the treatment of obesity.

According to Novo Nordisk, the drug maker and sponsor of the Select study, the agency’s analysis of wegovy is expected to end by early 2023. Currently, it is marketed only in the United States.

As there is still no authorized drug for the treatment of obesity, the use of semaglutide for this purpose in the country is considered off-label (when a drug is prescribed for a purpose different from that seen on the leaflet).

Novo Nordisk states in a statement that it “does not endorse or support the promotion of off-label information.”

A similar position is pointed out by Rizzi. “Only what is written is valid. As long as it is not on the package insert, it is not valid. Even if other countries have already approved it, as long as our regulatory agency does not say that it is, it is not.”