Two Danish studies, carried out by researchers at the University of Southern Denmark (SDU), showed that people treating type 2 diabetes with Ozempic have an increased risk of developing damage to the eye’s optic nerve, which can lead to serious and permanent loss of vision. One of the works was published in December in the International Journal of Retina and Vitreous and the other is being peer reviewed.
The new work reinforces a concern already highlighted by a previous study, published in July 2024. In the American work, it was observed that Ozempic, a medicine for the treatment of type 2 diabetes developed by Novo Nordisk, can more than double the risk of a disease A rare condition called NAOIN (non-arteritic anterior ischemic optic neuropathy), which causes damage to the optic nerve.
Danish researchers validated the American study’s hypothesis in Denmark, where the drug is used by 106,454 patients to treat type 2 diabetes. They examined data from these users and found that the number of NAION cases has increased since Ozempic hit the market, in 2018.
“While we used to see between 60 and 70 cases of NAION per year, we are now seeing up to 150. Furthermore, we have noticed that patients arriving at the hospital due to NAION are most often patients with type 2 diabetes,” says Jakob Grauslund, leader of the study, in press release.
What is NAION?
NAION is an irreversible condition characterized by damage to the eye’s optic nerve, which can lead to severe and permanent vision loss. It is caused by the sudden cutoff of the blood supply to the optic nerve, resulting in loss of visual acuity (sharp vision) or a significant reduction in the field of vision.
Among the risk factors for developing the disease are diabetes, high blood pressure and high cholesterol. Smoking can also increase your chances of developing the disease, according to Brigham and Women’s Hospital.
How was the study carried out?
In one of the studies, researchers divided patients into two groups: those treated with Ozempic and those who received another treatment for type 2 diabetes.
In this work, they found that the risk of developing NAION is doubled in patients treated with Ozempic. In statistical analyses, factors such as age, gender, blood sugar and a wide range of other conditions were also taken into account.
In the second study, researchers examined a smaller but more specific sample of patients with type 2 diabetes. They compared new users of Ozempic with users of another medication used for the same disease. This ensures a more uniform comparison between patients.
“In collaboration with the Norwegian Institute of Public Health, we looked at all Danish and Norwegian patients with diabetes who started treatment with Ozempic and compared them with people who started treatment with another medicine. What was the case with Jakob Grauslund? [líder do primeiro estudo]we found that the risk of developing NAION doubles if you take Ozempic”, explains Anton Pottegård, Professor of Pharmaceuticals at the Department of Public Health.
Both studies indicate that the risk of NAION applies to all patients with type 2 diabetes who used Ozempic, regardless of the severity of the disease.
“Fortunately, according to our study, the number of people affected is lower than what was found in the American study, but the number of NAION cases among people receiving Ozempic still doubled,” says Grauslund.
“The American study proposes a hypothesis about a possible association, so it was important to investigate whether it could be confirmed in follow-up studies with better data sources – data sources like the ones we have access to in the Nordic region”, adds Pottegård.
Researchers do not recommend stopping treatment with Ozempic
Despite the results of the studies, the researchers do not intend to encourage the interruption of type 2 diabetes treatment with Ozempic.
“This is a serious but very rare side effect. We often only learn about this kind of thing after a new drug has been on the market for a few years, like Ozempic. It must be emphasized that it is neither more serious nor more common than the rare side effects of many other medications that we continue to use. It is, so to speak, just a new piece of the puzzle of understanding how this medicine works”, highlights Anton Pottegård.
The researchers hope that the results of the study can be used by doctors and patients to discuss the pros and cons of treatment with Ozempic.
What Novo Nordisk says
In a note sent to CNN Novo Nordisk states that, after a detailed evaluation of the studies and the company’s internal safety analysis, the pharmaceutical company “maintains the opinion that the benefit-risk profile of semaglutide [princípio ativo do Ozempic, assim como do Wegovy e do Rybelsus] remains unchanged.”
“Although both studies showed an approximate increase in relative risk, the absolute risk and absolute number of people affected are very low. This is in line with the very low annual incidence of this rare disorder. One of the studies found that 2 people per 10,000 patients treated with semaglutide per year developed NAION, compared with 1 per 10,000 in the control group, concluding that the absolute risk is very low. Studies have not demonstrated a causal relationship between semaglutide and NAION”, states the note.
The pharmaceutical company also states that it carried out an analysis of randomized and controlled clinical trials with GLP-1 receptor agonists [classe da semaglutida]including an evaluation by an independent ophthalmologist, to confirm NAION diagnoses. “Through this analysis, very few confirmed cases of NAION were identified, without an imbalance that would disfavor Novo Nordisk’s GLP-1 receptor agonists,” he says.
“Patient safety is a top priority for Novo Nordisk, and we take all reports of adverse events related to the use of our medicines very seriously. This also applies to eye conditions, which are well-known comorbidities in people with diabetes. Any decision to start treatment with prescription medications must be made in consultation with a healthcare professional, who must carry out a risk-benefit assessment for the patient, weighing the benefits of treatment with the potential risks”, highlights the company.
This content was originally published in Ozempic may double the risk of rare eye disease, new studies suggest on the CNN Brasil website.
Source: CNN Brasil
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