According to experts, the study has not demonstrated a cause and effect relationship and the drugs should continue to be indicated for asymptomatic people.
Brazilian medical societies released a clarifying note on Friday 12th study that associated the use of semaglutideactive ingredient of medicines Ozempic, Wegovy and Rybelsus, to an increased risk of nonarteritic anterior ischemic optic neuropathy (NAION-NA), a rare eye disease that affects the optic nerve and can lead to blindness.
The text, signed by the Brazilian Society of Diabetes (SBD), the Brazilian Association for the Study of Obesity and Metabolic Syndrome (Abeso), the Brazilian Society of Endocrinology and Metabology (SBEM) and the Brazilian Society of Ophthalmology (SBO), highlights that there are limitations in the research and, to date, there is no evidence of causality between the use of semaglutide and the emergence of NAION.
“To date, there is no evidence of causality between the use of semaglutide and the emergence of NOIA-NA. However, new studies, especially large real-life studies dedicated to the evaluation of ocular health in patients using semaglutide, are awaited to clarify this issue,” the note reads.
Experts say that the use of semaglutide should continue to be normally indicated for asymptomatic people, “but only by doctors, being strongly condemned its use without a medical prescription and for weight loss in people without obesity or overweight with comorbidities”.
What do medical societies say?
In the note, the entities specify that their scientific committees have analyzed in detail the study, developed by researchers at Mass Eye and Ear, a university hospital in Harvard University focusing on the health of the eyes, ears, nose, throat, head and neck – and published in the scientific journal JAMA Ophthalmologyand highlight the following aspects:
- of 17,298 patients with neuro-ophthalmological diseases from a specialized neuro-ophthalmology clinic, 710 people with diabetes and 979 with obesity were selected;
- 555 selected patients were using semaglutide and among them, there were 37 cases of NAION, or 6.6%;
- of 1,134 people with diabetes or obesity not using semaglutide, nine cases of NAION occurred, or 0.79%;
- This difference was statistically significant, in relative terms.
On the other hand, they believe that the study was observational and not randomized, meaning that people who used semaglutide were not randomly selected to receive the drug, but rather were chosen from medical records to be included in the study based on previous use. Because of this selection, there is no way to say that those who used semaglutide had a similar risk of NAION as people who did not receive the drug.
Furthermore, risk factors such as smoking, duration of diabetes, and optic disc morphology were not taken into account. The study did not assess whether patients in the semaglutide group actually followed the prescription correctly, as there was no monitoring of the medications. adherence. Information on semaglutide doses was also not presented, preventing us from examining whether higher doses were associated with a higher incidence of NAION.
The organizations also emphasize that NOIA-NA is a rare disease, with a prevalence of 2 to 10 cases per 100,000 people in the general population, or 0.002% to 0.01%, and that the group that did not use semaglutide had a rate of 0.79% – well above the norm. For doctors, this indicates that the results were obtained in a population at much higher risk, which limits the possibility of extrapolating the results to the general population.
“Therefore, it is not possible to conclude from this study that there is a causal relationship between the use of semaglutide and the occurrence of NAION. There is no way to state, with these data, that semaglutide caused an increase in cases of NAION-NA,” the note reads.
The companies also recall that, in 13,809 patients who received semaglutide in previously randomized studies, no cases of NAION were reported and emphasize the benefits of using semaglutide in both weight loss and hyperglycemia control in patients with type 2 diabetes, reducing the risk of cardiovascular events and reducing the progression of diabetic kidney disease.
“SBD, ABESO, SBEM and SBO acknowledge that while there may have been an increased relative risk of NAION in people using semaglutide, the absolute increase in risk was very low and should not be a reason for discontinuation of treatment,” the statement said.
Recommendations
The societies recommend that people with diabetes have routine and periodic retinal exams as part of disease monitoring, as required by current guidelines.
Currently, the leading cause of blindness in patients with diabetes is diabetic retinopathy. Novo Nordisk, maker of Ozempic and Wegovy, announced that an ongoing study is examining the long-term effects of semaglutide 1.0 mg in this condition. The study is expected to be completed in the second half of 2027.
In relation to subjects who have already had NOIA-NA or who present a sudden or recent loss of vision, medical authorities state that semaglutide must be immediately discontinued and the patient must undergo an ophthalmological examination as soon as possible. The therapeutic decision must be made on a case-by-case basis, together with the ophthalmologist.
Source: Terra
Ben Stock is a lifestyle journalist and author at Gossipify. He writes about topics such as health, wellness, travel, food and home decor. He provides practical advice and inspiration to improve well-being, keeps readers up to date with latest lifestyle news and trends, known for his engaging writing style, in-depth analysis and unique perspectives.
