(Bloomberg) — Novo Nordisk A/S’s blockbuster shot Ozempic was linked to an elevated danger of a uncommon type of imaginative and prescient loss in a examine that backs up Harvard University analysis printed earlier this yr.
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Diabetes sufferers who used Ozempic had been greater than twice as prone to be recognized with the uncommon situation, known as NAION, than those that took one other kind of diabetes drug, in response to a workforce of researchers who studied years of affected person information from Denmark and Norway. The examine wasn’t in a position to decide whether or not there was an analogous impression amongst folks taking Ozempic’s sister drug, Wegovy, for weight problems.
The outcomes appeared Dec. 11 on medRxiv, a web site that posts research earlier than they’ve been reviewed by exterior scientists.
NAION happens when a lack of blood movement damages the optic nerve and is commonest in folks older than 50. Diabetes itself, coronary heart illness, sleep apnea and different situations may also elevate the danger that it’s going to strike. The total price of the situation was very low within the examine, with simply 1.4 extra instances per 10,000 years of affected person commentary amongst sufferers who took Ozempic in contrast with those that took the opposite diabetes drug.
Still, the attention situation is irreversible, untreatable and probably blinding, and docs have stated that sufferers needs to be knowledgeable of the doable danger. The corresponding creator on the examine declined to remark.
Novo shares fell as a lot as 5.4% in Copenhagen, probably the most in a few month. The inventory has climbed about 8% this yr, outpacing an increase of round 4% in a Bloomberg index monitoring European pharmaceutical corporations.
Weighing Benefits
Assuming the danger stays fixed over time, the outcomes point out {that a} kind 2 diabetes affected person taking Ozempic for 20 years would have a 0.3% to 0.5% likelihood of growing NAION, the analysis workforce stated.
“It is essential to weigh the potential danger of NAION in opposition to the substantial therapeutic advantages of semaglutide,” the lively ingredient in Ozempic and Wegovy, in response to authors from the University of Southern Denmark, Norwegian Institute of Public Health and University of Copenhagen, in addition to different establishments that performed the analysis.
After an intensive analysis of this examine and its personal inside security evaluation, Novo stated it believes the risk-benefit profile is unchanged. Very few instances of NAION had been seen in Novo’s personal trials, the corporate stated, “with no imbalance disfavoring” its medication.
Hints of a hyperlink to NAION first emerged in a smaller examine printed in July by a workforce from the Harvard-affiliated hospital Massachusetts Eye and Ear. It’s an instance of how very uncommon potential uncomfortable side effects could emerge solely after extraordinarily massive numbers of individuals use a medication.
The Nordic examine discovered a smaller added danger of NAION than the Harvard trial did. That trial centered on sufferers who had in some unspecified time in the future been referred to a health care provider for a neuro-ophthalmological evaluation, the Danish-Norwegian workforce famous, and will have been sicker in consequence.
The Nordic examine in contrast customers of semaglutide and individuals who took medicines in an older class of medication, known as SGLT-2s. It adopted new customers of the medication in Denmark and Norway from the start of 2018 — the yr Ozempic was launched in these markets — till June 2024 in Denmark and May 2022 in Norway. The researchers included greater than 44,000 Ozempic sufferers in Denmark and greater than 16,000 in Norway, discovering 32 instances of NAION in all the group.
The findings with Wegovy, which grew to become obtainable in Denmark in 2022 and in Norway in early 2023, had been inconclusive as a result of not sufficient sufferers had been included.
–With help from Robert Langreth.
(Updates with shares within the sixth paragraph)
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