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Two impartial research from the College of Southern Denmark (SDU) present that sufferers with sort 2 diabetes who’re handled with the drug Ozempic have an elevated danger of growing harm to the optic nerve of the attention, which may result in extreme and everlasting lack of imaginative and prescient. Each research are based mostly on Danish registers and are the most important on this planet.
Of their separate research, Jakob Grauslund, Professor of Ophthalmology, and Anton Pottegård, Professor of Prescription drugs, have used two completely different strategies to analyze all Danish customers of Ozempic.
Each of the brand new register-based research from SDU verify a priority that was raised earlier this yr in a smaller American research. Within the American research, it was noticed that Ozempic greater than doubles the danger of the uncommon situation NAION (non-arteritic anterior ischemic optic neuropathy), which causes harm to the optic nerve of the attention.
Jakob Grauslund and his analysis colleagues have validated the speculation of the American research in Denmark, the place the drug Ozempic is utilized by 106,454 sufferers within the remedy of sort 2 diabetes.
“We have examined data from all 424,152 Danes with type 2 diabetes. We found that Ozempic more than doubles the risk of developing NAION. NAION is damage to the optic nerve of the eye caused by a sudden stop of blood flow to the optic nerve. It is a condition that can lead to severe and permanent loss of vision,” says Grauslund, Professor of Ophthalmology on the Division of Medical Analysis, SDU, and Division of Ophthalmology E, Odense College Hospital.
“In the study, we found that the risk is doubled. At the same time, in the clinic we have noticed that since Ozempic came on the market in 2018, the number of NAION cases in Denmark has continued,” he continues. “Whereas we used to see between 60 and 70 cases of NAION per year, we are now seeing up to 150. In addition, we have noticed that the patients who come to hospital due to NAION are more often patients with type 2 diabetes.”
In Grauslund’s research, the researchers divided the sufferers into two teams: those that had been handled with Ozempic and those that acquired different remedy. Within the statistical analyses, age, gender, blood sugar and a variety of different circumstances had been additionally taken under consideration.
Similar findings with a special technique
Anton Pottegård and his analysis group, who’re specialists on medication use, have carefully examined a smaller however extra particular pattern of the group of sufferers with sort 2 diabetes. They’ve in contrast new customers of Ozempic with customers of one other drug used within the remedy of diabetes who’re on the identical stage of the illness. This ensures a really even and direct comparability. They’ve carried out this in each Denmark and Norway.
“In collaboration with the Norwegian Institute of Public Health, we have looked at all Danish and Norwegian diabetes patients who started treatment with Ozempic and compared them with people who started treatment with another medication. As was the case for Jakob Grauslund, we found that the risk of developing NAION doubles if you take Ozempic,” explains Pottegård, Professor of Prescription drugs on the Division of Public Well being.
Danger is doubled
As with the American research, each research from the College of Southern Denmark present that Ozempic will increase the danger of growing NAION and that this is applicable to everybody with sort 2 diabetes and never simply to these sufferers who’re already very in poor health.
“Fortunately, according to our study, the number of people affected is lower than was found in the American study, but the number of cases of NAION among the people who are receiving Ozempic has still doubled,” says Grauslund.
The upper variety of instances within the American research could also be as a result of give attention to a restricted group of sufferers and since the American knowledge have plenty of limitations that aren’t relevant within the Scandinavian well being registers.
“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 such as those we have access to in the Nordic region,” explains Pottegård. “These are the registers we have now used to confirm this suspicion.”
May result in a change in remedy
Left untreated, diabetes can result in different adjustments and problems within the eyes. Though these circumstances are much less extreme than the harm brought on to the optic nerve by NAION, they’re much extra frequent. It’s subsequently not the intention of Grauslund and Pottegård to advise diabetes sufferers to cease their remedy.
“This is a serious but very rare side effect. Often, we only learn about this kind of thing after a new drug has been on the market for a few years, as is the case with Ozempic. It should be emphasized that it is neither more serious nor more common than the rare side effects of many other medicines that we continue to use. It is, so to speak, just a new piece of the puzzle of understanding how this drug works,” explains Pottegård.
“We hope that our results can be used by doctors and patients to discuss the pros and cons of treatment with Ozempic,” provides Grauslund.
Kurt Højlund is a professor of diabetes at Steno Diabetes Heart Odense, SDU and Odense College Hospital. He sees sufferers with sort 2 diabetes every single day and is answerable for selecting the most effective remedy for them.
Højlund is among the many group of authors behind one of many research. He says, “This can be very essential that sort 2 diabetes is handled, however you must think about whether or not the small elevated danger of extreme imaginative and prescient loss by utilizing Ozempic signifies that you must as a substitute use one of many different new medicine that shield in opposition to kidney and heart problems. That is commensurate with the brand new pointers which got here into drive on 25 November. We can’t but with certainty determine sufferers with a very excessive danger.
“However, treatment with Ozempic should be stopped if NAION is detected in one eye. The vast majority of patients can be confident in receiving treatment with Ozempic, as the absolute risk is so low, but some people may prefer an alternative treatment following consultation with their doctor.”
Danish and worldwide authorities have been knowledgeable of the findings. NAION as a possible aspect impact of semaglutide, the lively ingredient in Ozempic, has been a spotlight for the authorities over the previous six months. The brand new findings will probably be included into their ongoing work.
Grauslund’s research has been accepted within the Worldwide Journal of Retina and Vitreous, and Pottegård’s research is at present obtainable on the medRxiv preprint server.
Extra data:
Grauslund et al, As soon as-weekly semaglutide doubles the five-year danger of nonarteritic anterior ischemic optic neuropathy in a Danish cohort of 424,152 individuals with sort 2 diabetes
Emma Simonsen et al, Use of semaglutide and danger of non-arteritic anterior ischemic optic neuropathy: A Danish–Norwegian cohort research, medRxiv (2024). DOI: 10.1101/2024.12.09.24318574
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Diabetes drug linked to elevated danger of extreme eye situation (2024, December 16)
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